3m canada september 26, 2018 · september 26, 2018. time event 7:45 –8:15 breakfast/ registration...
TRANSCRIPT
Toronto Canadian Food Safety Symposium 20183M CANADA
September 26 2018
TIME EVENT
745 ndash 815 Breakfast Registration
820 ndash 830 Introduction
830 ndash 930 Speaker 1 Ken Davenport
930 ndash 1000 Speaker 2 Andreacute Cocircteacute
1000 ndash 1015 Break
1015 ndash 1045 Speaker 3 Wei Que
1045 ndash 1230 Speaker 4 Dr Worobo
1230 ndash 130 Lunch
130 ndash 300 Round Table
WRITE DOWN QUESTION THROUGHOUT THE DAY TO ASK SPEAKERS
3M STAFF WILL BE
WEARING RED BELTS
WASHROOMSBESIDE ELEVATORLEFT
ADDITIONAL IN RESTAURANT
BEVERAGES amp SNACKS WILL BE
PROVIDED AT BREAK TIMES
LUNCH VISIT ALL 4 TABLES WITH YOUR
PUNCH CARD FOR A CHANCE TO
WIN
PLEASE TURN YOUR PHONES OFF
IMPORTANT NOTES
KEYNOTE SPEAKERS
DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor
University
bull MBA from the University of Minnesota
bull PhD from the Department of Biochemistry at Rice University
bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications
bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment
Allergens amp HACCP
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
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What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
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What foods are most often regulated as allergens
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Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
TIME EVENT
745 ndash 815 Breakfast Registration
820 ndash 830 Introduction
830 ndash 930 Speaker 1 Ken Davenport
930 ndash 1000 Speaker 2 Andreacute Cocircteacute
1000 ndash 1015 Break
1015 ndash 1045 Speaker 3 Wei Que
1045 ndash 1230 Speaker 4 Dr Worobo
1230 ndash 130 Lunch
130 ndash 300 Round Table
WRITE DOWN QUESTION THROUGHOUT THE DAY TO ASK SPEAKERS
3M STAFF WILL BE
WEARING RED BELTS
WASHROOMSBESIDE ELEVATORLEFT
ADDITIONAL IN RESTAURANT
BEVERAGES amp SNACKS WILL BE
PROVIDED AT BREAK TIMES
LUNCH VISIT ALL 4 TABLES WITH YOUR
PUNCH CARD FOR A CHANCE TO
WIN
PLEASE TURN YOUR PHONES OFF
IMPORTANT NOTES
KEYNOTE SPEAKERS
DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor
University
bull MBA from the University of Minnesota
bull PhD from the Department of Biochemistry at Rice University
bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications
bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment
Allergens amp HACCP
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
WRITE DOWN QUESTION THROUGHOUT THE DAY TO ASK SPEAKERS
3M STAFF WILL BE
WEARING RED BELTS
WASHROOMSBESIDE ELEVATORLEFT
ADDITIONAL IN RESTAURANT
BEVERAGES amp SNACKS WILL BE
PROVIDED AT BREAK TIMES
LUNCH VISIT ALL 4 TABLES WITH YOUR
PUNCH CARD FOR A CHANCE TO
WIN
PLEASE TURN YOUR PHONES OFF
IMPORTANT NOTES
KEYNOTE SPEAKERS
DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor
University
bull MBA from the University of Minnesota
bull PhD from the Department of Biochemistry at Rice University
bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications
bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment
Allergens amp HACCP
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
KEYNOTE SPEAKERS
DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor
University
bull MBA from the University of Minnesota
bull PhD from the Department of Biochemistry at Rice University
bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications
bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment
Allergens amp HACCP
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor
University
bull MBA from the University of Minnesota
bull PhD from the Department of Biochemistry at Rice University
bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications
bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment
Allergens amp HACCP
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Allergens amp HACCP
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Humans love and need food
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Food allergy prevalence
bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population
bull 4-8 in infant and young children population
bull Cowrsquos milk egg and peanuts among the most common allergenic foods
can change depending of region and dietary patterns
bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
9 All Rights Reserved11 December 2018copy 3M
What is an allergen
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
10 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Micro-nutrients
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
11 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Not susceptible population
Micro-nutrients
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
12 All Rights Reserved11 December 2018copy 3M
What is an allergen
The composition of most foods includes four elemental components
Carbo-hydrates
Lipids
Proteins
Some people will have immune systems that will mistake some food proteins for
infectious agents and aggressively attack the proteins
Allergen
Allergen
Not susceptible population
Allergic reactionSusceptible population
Micro-nutrients
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
13 All Rights Reserved11 December 2018copy 3M
An allergy is different from a food sensitivity or allergy-like intoxications
Adverse reaction to food
IgE mediated
Food allergy
Non- IgE mediated
Allergy-like intoxication
Ingestion of histamine produced in foodScombroid fish
poisoning
Senstivity
Sulfite inducedasthma
Strawbery or chocolate induced
histamine
Lactose intolerance
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
14 All Rights Reserved11 December 2018copy 3M
What IS food allergy
Food allergy symptoms
Gastro-intestinalVomitingDiarrheaNausea
Abdominal cramps
RespiratoryAsthma
Wheezingrhinitis
CutaneousUrticaria (hives)
EczemaDermatitis
Rashangioedema
Extreme symptomsAnaphylactic shock
HypotensionSwelling of tongueLaryngeal edema
OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy
Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
15 All Rights Reserved11 December 2018copy 3M
What is NOT a food allergy
Lactose Intolerance
ldquoAllergicrdquo to Sulfite in Wine
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
16 All Rights Reserved11 December 2018copy 3M
What foods are most often related to food allergies
Additional
bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits
The big 8 Plus additional ones depending on country and region
True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf
What foods are most often regulated as allergens
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
18 All Rights Reserved11 December 2018copy 3M
Preventing food allergies in the human population
ALLERGEN CONTROLSegregation
Prevent cross-contactLABELLING
Allergen free
Allergen content
May contain
statements
FSMAPreventive
controls
HACCPPreventive
controls
GMPsPreventive
controls
Environmental monitoring
Preventive controls
CleaningPreventive
controls
Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
19
3M Health Care AcademySM
HACCP Overview
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
HACCP
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
20
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
21
3M Health Care AcademySM
Introduction to HARPC
The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the
paradigm for food safety regulations and FDA inspections for the US
Requires a written Food Safety Plan containing
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification program
- Written recall plan
Hazard Analysis and Risk-based Preventative Controls
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
22
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
23
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
24
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
25
3M Health Care AcademySM
Risk-Based Preventative Controls
- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or
refrigerating)
- Maximum andor minimum values for the hazard to prevent the hazard occurring
- Process controls must include procedures practices and processes performed on food
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
26
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
27
3M Health Care AcademySM
Why the new ldquopreventative controlsrdquo
- Food allergen controls must be explicitly identified
- Labeling of the finished food to ensure compliance
- Sanitation controls
Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs
The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
28
3M Health Care AcademySM
Comparison of HARPC and HACCP
1 Conduct Hazard Analysis
2 Identify CCPs
3 Establish Critical Limits
4 Establish Monitoring Actions
5 Establish corrective Actions
6 Establish Verification Procedures
7 Establish a Record-Keeping System
- Written Hazard Analysis
- Written and validated preventative controls
- Written corrective action procedures
- Written verification procedures
- Written supplier approval and verification
program
- Written recall plan
HACCP HARPC
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
29 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
30 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
Primary to minimally processed ingredients
Specification about residual allergen content
Example Codex Standard for wheat allow up to 3 other grains
Raw material segregation (ierice flour from wheat flour)
Dedicated or Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION CLEANING VERIFICATION
Confirmation you have the right productRMs
Test ldquofirst off the linerdquo
Test ldquorepresentative samplerdquo for allergens
bull Often quantitativebull Often 3rd party lab
Product Testing Product
Testing
Environmental testing
Qualitative Product Testing
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
31 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
32 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS
bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label
Support risk assessment and risk
management activities
Usually a quantitative analysis is required
ELISA
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
33 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
34 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VALIDATION
Usually a quantitative analysis is required
ELISA
Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
35 All Rights Reserved11 December 2018copy 3M
Allergen control during manufacturing VERIFICATION
Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective
a Rapid allergen testb Rapid protein testc ATPd Visual inspection
Allergen testing can be (should be) part of the environmental monitoring programs
Support risk management activities
Usually a qualitative analysis is required
Lateral Flow Devices
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
36 All Rights Reserved11 December 2018copy 3M
Allergen testing
Quantitative
Qualitative
Requires to know concentration of allergen
protein in the food
Presenceabsence is sufficient to trigger corrective actions
(at a certain level of detection)
Final product
Rinse waterCIP
CIP Clean In Place final rinse water
Swabs
Most common during process
VALIDATION
Raw material
Final product
Rinse waterCIP
SwabsRaw
material
In many cases through third party reference or service
lab
Most common during process
VERIFICATION
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
37 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
ELISA (Enzyme Linked Immuno-Sorbant Assay)
Antibody based method
Detect presence of protein by making an antibody
sandwich amp detecting a marker (enzyme) linked to one of
the antibodies (conjugated antibody)
YYYYYY YYYYYY
Positive Negative
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
ELISA tests ndash what the results look like
Negative
Positive
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
40 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
41 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsResults
Positves results may appear as fast as in 5 min
Once is positive stays positive
A negative result should be confirmed at 11 + 1 min
After 12 min the strip is not valid
The intensity of the band is irrelevant a faint line is as positive as a strong line
(Gluten does not have an H line)
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Lateral Flow ndash Positive Test
YYY YYY
Test Hook Control
Y
Allergen Protein
Other Protein
Antibody with Gold Bead
Capture Antibody
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Lateral Flow ndash Negative Test
YYY YYY
Test Hook Control
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Lateral Flow ndashControl Lines - denatured
YYY YYY
Test Hook Control
Ex pH 3DetergentAlcohol
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Lateral Flow ndash Hook Line for Overload
YYY YYY
Test Hook Control
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
46 All Rights Reserved11 December 2018copy 3M
Allergen control in food manufacturing operations
Raw material selection and specification
Manufacturing operations Finished Product Testing
bull Primary to minimally processed ingredients
bull Specification about residual allergen content
bull Example Codex Standard for wheat allow up to 3 other grains
bull Codex Standard for maize allows up to 2 of other grants
bull Raw material segregation (ie rice flour from wheat flour)
bull Shared manufacturing lines
Ex Gluten free pasta and wheat pasta should avoid cross-contact
CLEANING VALIDATION amp VERIFICATION
Confirmation you have the right productRMs
bull Test ldquofirst off the linerdquo
bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab
Product Testing
Product Testing
Lateral Flow
Qualitative Product Testing -
Lateral Flow
Generally ELISA (could use Lat
Flow)
ELISA
ELISA
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
47 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
CleaningCleaning
Verification
Production Start
ldquoFormula Verificationrdquo
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
48 All Rights Reserved11 December 2018copy 3M
3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs
SOLID FOOD
LIQUID FOOD
SWABSCIP
rinse water
3M LFD Differentiation
3M LFD Differentiation
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
49 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Processing can either increase or reduce allergenic effect no guarantee
Heat Treated roasting
pasteurization cooking baking
bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour
bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked
cake
This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
50 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal
Antibodies raised only against unprocessed proteins recognize a
particular epitope
Antibodies may be unable to bind to the
processed protein
No epitope recognition
Heat Treated roasting
pasteurization cooking baking
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
51 All Rights Reserved11 December 2018copy 3M
Immunoassays in food testing Impact of food processing
Polyclonal antibodies recognize several epitopes
Even if both antibodies bind to fragments because the fragments
arenrsquot connected you get a FALSE-Negative Test Result
in ELISA and LFDs
Protein Break-down Process
FermentationEnzymatic Digestion
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
THANK YOU
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
DR RANDY WOROBObull Professor of Food Microbiology at
Cornell University
bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables
bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs
bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Controlling for Food Spoilage Using Environmental Monitoring
Presented by
3M Food Safety
Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Where does microbial contamination come from in a food production facility
Animals
Humans
Inanimate Objects
(food contact surfaces)
Rodents amp Pests
Environmental
FOOD
(Modified from Beuchat)
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Controlling Microbial Contamination
bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities
bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs
bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Goals of a Microbial Environmental Testing Program
bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning
bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and
locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific
piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control
(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Seek and Destroy
bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample
bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg
new equipment qualification) or the facility as a whole
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Where to Test
bull Food contact surfacesbull Food contact surface positives may have to be followed up with
finished product testing
bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)
bull Tubs conveyances underneath tables
bull Floors floor mats walls amp drains in production areas
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Where to Test ndash The Zone Concept
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Where to Test
bull Nichesbull Hollow rollers table legs etc floor wall
junctures floor cracks difficult to clean areas seals on doors etc
bull Sampling of niches more likely to identify source
bull Transfer pointsbull Hands door handles
bull Sampling of transfer points requires follow up to identify source
bull Some areas could be bothbull Key boards
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Other Sampling Considerations
bull Must select samples to find positivesbull Subtleties of sampling are much more important with
environmental samples as compared to finished product samples
bull Need to set up a system that encourages collection of samples that yield positive results
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Hygiene and environmental monitoring and management programs
bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess
sanitary conditions
bull Document to meet regulatory requirements
bull Manage for efficiencybull Review of data collected to identify potential areas of improvement
bull Review of data collected to identify and prevent future issues
Verifying Effectiveness of Cleaning and Monitoring the Environment
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Measuring the Effectiveness of Cleaning and Sanitation
All have their place in a robust hygiene
monitoring program
Visual inspection
ATP bioluminescence
Traditional microbiology
(swab amp plate)
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Measuring the Effectiveness of Cleaning and Sanitation
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
ATP is the ldquoenergy currencyrdquo molecule of all living organisms
What is ATP
Adenosine
Phosphates
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Sources of ATP
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
How ATP Bioluminescence Works
ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule
of all living organisms
Increasein organisms
or organic residues
Increase in ATP levels+
Luciferinluciferase
Increasein light (RLU)
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Simple Relationship
Increase in organic residues
Increase in ATP levels
Increase in light (RLU)
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Benefits of Using ATP as a ldquoRiskrdquo Indicator
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Survey of 8 Beverage Facilities
1 Both cleaning and sanitation
practices and testing are not
only for FCS but also for non-
FCS
2 Fabrication of the surface is
important in terms of its clean-
ability
3 Continual sanitation operations
during production reduce
environmental contamination
0
100
200
300
400
500
600
700
800
900
1000
Drain Floor Container Bottling line Clean StainlessSteel Tank
RL
Us
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
1 Identify testing locations
2 Determine the testing frequency
3 Analyze the data
4 Implement short-term corrective actions
5 Perform root cause analysis
Guidance on Building a Hygiene Management Program
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Environmental Monitoring
bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)
bull Indicator organism testing
bull Spoilage organism testing
bull Pathogen testing
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Production Line
ATP Testing
Forklift Cart
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
MicroIndicator Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Pathogen Testing
Facility Sampling Guidance
Packaging WarehouseRM
Warehouse
Finished Goods
Production Line
Forklift Cart
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
bull Risk Analysis 101
bull How significant is the Hazard
bull How close is the surface to the food
bull What is the Probability the Hazard will occur
bull How hard is it to clean the surface
Test Point Selection Process
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Low Medium High
High
Medium
Low
Probability
Color = risk level
Test Point Selection Process
How Close to the Food
Zone 1 Direct Contact
Zone 2 Indirect Contact
Zone 3 Close Proximity
Zone 4 General Area
How close to food How hard to clean
Ha
zard
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Mixer
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Wall
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Unlikely
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Probe
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Possible
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Drain
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard High impactProbability Probable
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Outside Hull
Example Jacketed Mixer Kettle
Low Medium High
High
Medium
Low
Probability
Haz
ard
Hazard Moderate impactProbability Unlikely
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Weight
Blade
Tray
Collection Pan
Collection Side
Slice Thickness Knob
Slicer Handle
Example Meat Slicer
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Low Medium High
High
Medium
Low
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Find trends in the data trends in the plant
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Immediately identify cost savings
Identify potential increased costs
bull Visualize trends
bull By sample point
bull By particular day or week
bull Easy to interpret
bull Align resources
bull Justify resources
bull Existing and new
Ranking and Trending Reports
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Making the Most From your Data
Coliform Trends from 2006 - 2008
90
92
94
96
98
100Ja
n-0
6
Ma
r-0
6
Ma
y-0
6
Ju
l-0
6
Se
p-0
6
No
v-0
6
Ja
n-0
7
Ma
r-0
7
Ma
y-0
7
Ju
l-0
7
Se
p-0
7
No
v-0
7
Ja
n-0
8
Ma
r-0
8
Ma
y-0
8
Time (months)
o
f c
olifo
rm
s lt
1 c
fum
L
Test Point Trend 2006-08
0
20
40
60
80
100
120
140
160
802
06
130306
130606
230806
311006
170307
110707
180707
250707
310707
908
07
240807
300807
709
07
261107
301107
712
07
Time
RL
U Pass Limit
Result
Introduction of ATP
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Striving for Continual Improvement
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
⦁ Measured Aerobic Count in finished product
⦁ AC target is lt10 x 105 CFUg
bull Many many samples had been failing the AC target levels
Food Manufacturer Case Study 1
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9
SAMPLE NUMBER
CF
UG
1901
2104
Provided by 3M Food Safety
Food Manufacturer Case Study
This graph shows the microbiology (total aerobic count) data for finished product testing
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
APC GRAPH CORN 2008
0
50000
100000
150000
200000
250000
300000
350000
1
25
49
73
97
12
1
14
5
16
9
19
3
21
7
24
1
26
5
28
9
31
3
33
7
36
1
38
5
40
9
43
3
45
7
48
1
50
5
52
9
55
3
57
7
60
1
62
5
64
9
67
3
69
7
72
1
74
5
76
9
79
3
81
7
84
1
86
5
88
9SAMPLE NUMBER
CF
UG
1901
2104
Introduction of ATP testing
2009 corn season APC results
0
50000
100000
150000
200000
250000
300000
350000
1
19
37
55
73
91
10
9
12
7
14
5
16
3
18
1
19
9
21
7
23
5
25
3
27
1
28
9
30
7
32
5
34
3
36
1
37
9
39
7
41
5
43
3
45
1
46
9
48
7
50
5
52
3
54
1
55
9
57
7
59
5
61
3
63
1
64
9
66
7
68
5
sample number
AP
C
spec limit
280109020209
1804
Food Manufacturer Case Study
Significant improvement in finished product quality almost immediately
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
⦁ Additional microbiological testing reveals Asaia spp
⦁ Acetic Acid Bacterium
⦁ Cleaning amp sanitation records (CIP amp COP) acceptable
Food Manufacturer Case Study 2
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Identifying the Contamination Source
0
05
1
15
2
25
3
35Ingredients
Well water
Mixing tank
Pasteurized Bulk HoldingTank
Filler
Log
CFU
ml o
r g
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Identifying the Contamination Source ndash ATP swabbing
0
500
1000
1500
2000
2500
3000
3500
4000
4500Water line to mixing tank
Mixing tank
Filler
Pasteurized Bulk HoldingTank
Line to pasteurizer
RLU
Val
ue
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
⦁ Line to filler from pasteurized bulk holding tank
was not in CIP loop
⦁ Sanitizer used was peroxyacetic acid
⦁ Asaia is aciduric so acid-based sanitizers are less
effective
⦁ Line to filler was non-sanitary welds amp corroded
Root Cause Analysis
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
⦁ Filler line from pasteurized bulk holding tank
replaced with new stainless steel pipe fabricated
with sanitary grade welds and included in CIP
loop
⦁ Chlorine based sanitizer used throughout the
facility
Corrective Procedures
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
⦁ Tofu manufacturer
⦁ Vacuum packaged refrigerated pasteurized
product
⦁ Customer complaints of off flavors and odors
⦁ Elevated finished product counts on APC
⦁ Pasteurization records indicate critical limits are
being met
Food Manufacturer Case Study 3
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
⦁ Gram negative spoilage organism identified (heat
sensitive
⦁ Packaging integrity confirmed
⦁ Deep cleaning of equipment reduced spoilage
incidence but gradually increased over time
Food Manufacturer Case Study 3
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Identifying the Spoilage Source
0
1
2
3
4
5
6
7Formed tofu
cut tofu
Cooling tank
Vacuum packagedunpasteurized
Pasteurized finishedproduct
Log
CFU
ml o
r g
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing
Problem spots
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
RCA
⦁ Conveyortank not sanitary design amp poor
cleaning
Corrections
⦁ Sanitary design conveyor for improved cleaning
Root Cause Analysis amp Corrections
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
bull Cleaning and sanitation regime are essential to ensuring the
safety and quality of your hygiene management program
bull ATP luminescence testing can provide a rapid evaluation of the
cleaning and sanitation regimes for all contact surfaces
bull Can be used to identify sources for microbial contamination
(safety amp quality) that may be from practices and the facility
bull As part of a routine environmentally monitoring program it can
identify trends and prevent potential problems
Key Points to Consider
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Thank youThank You
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
LUNCH
bull 1230 ndash 130
Donrsquot forget to visit our booths for your chance to win
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
Add a Slide Title - 5THANK YOU
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
HEALTH CARE ACADEMY
VISIT FOR MORE EDUCATIONAL
CONTENT AND HOW-TOrsquoS
3mcahealthcareacademy
