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Manufacturing Hygiene UKC Oct 13
7 steps QA Approach
Pers and Mfg Hygiene
STATUTORY REQUIREMENTS / GMP - TEA COMPLIANCE
BEVERAGES
PRODUCT : TEA
PFA IN-HOUSE SAFETY TESTING
SL PFA PARAMETERS LIMITS LIMITS MARGIN @ FREQUENCY
NO (ON DRY BASIS)
A ANALYTICAL PARAMETERS ( A 14 )
1 TOTAL ASH ( % BY WEIGHT ON DRY 4 - 8 4.25 - 7.75 0.25
MATTER)
2 ASH SOLUBLE IN BOILING WATER 40 43 3
AS % OF TOTAL ASH (Min)
3 ASH INSOLUBLE IN HCL % BY WEIGHT 1 0.98 0.02 Blend paper wise
ON DRY MATTER Max
4 ALKALINITY OF SOLUBLE ASH 1.0 - 2.2 1.1 - 2.0 0.1 - 0.2
AS K2O BY MASS (%)
5 WATER EXTRACT OBTAINED BY 32 32.5 0.5
BOILING TEA IN WATER FOR 1 HOUR
UNDER REFLUX ( % Min )
6 CRUDE FIBRE % BY WEIGHT ON 17 16 1
DRY MATTER ( Max)
7 IRON FILINGS (PPM) - Max 250 -
8 MOISTURE (%) - Max 7.0 -
Ensure full
compliance with
Statutory /
Mandatory
Requirements
STEP-2
BRAND QUALITY OBJECTIVES
Understand the
changing
Expectations of
the Consumers ,
apply QFD &
Develop Brand
Quality Objectives
STEP-3
• Bacterial growth & survival are dependent on:
– pH
– Temperature
– Water activity (aw)
– Nutrition
– Presence/absence of antimicrobials or preservatives
Product & Process Design
RIGHT PRODUCT & PROCESS DESIGN
Design Robust
Product /
Processes
STEP-4
Good Manufacturing Practice - GMP
Design Control Points - DCP
HACCP
Ensure GMP / GHP before embarking on HACCP
STEP-5 Implement HACCP
Right Hardware / Infrastructure and
Implementation of GHP / GMP( Category)
• Pest Proofing
– Food Handling Area
• Building / Roof / Wall / Floor
drain
• Storage and handling
facilities
• Laboratory
• Personnel Hygiene
Infrastructure
– Hygiene Station at entrance
– Change room
– Toilet
– PPE
• Handling of lubricants /
cleaning aids / chemicals etc.
• Process robustness
(pasteurisation, handling
of preservatives etc.)
• Water management
• Air
• Valves
• Pumps
• Pipeline / fittings
• Heat Exchangers/Vessels
• Generic CCPs
• Cleaning & Disinfection
• Rework Handling
• Offline Processing
Plant & Building Infrastructure Manufacturing Hygiene & Design
STEP-6
PEOPLE
SYSTEM HARDWARE PRODUCT
Four Legs Of a Sound QUALITY SYSTEM
Delighted
CUSTOMER
&
Empowered
EMPLOYEE
STEP-7 Sound Quality & Con
Safety Mgt.Systems
Manufacturing Hygiene :
Preliminary Risk Assessment
• Identify critical points in design
• Identify missing data
• Identify key issues that needs
verification during factory visit
2. Inspection & Factory Visit
• Factory design & lay-out
• Personnel
• Product
• Process
FOCUSS ON HYGIENE
Factory Design & Lay-out
• Site & infrastructure
• Building design & lay-out
• Utilities
• Pest control
2. Inspection & Factory Visit
Factory Design & Lay-out
• Site & infrastructure
• Building design & lay-out • Utilities
• Pest control
Checklist
• Site location
• Access control
• Hard surface
• Potential sources of contamination
(e.g.waste water treatment, farms)
2. Inspection & Factory Visit
Factory Design & Lay-out
• Site & infrastructure
• Building design & lay-out
• Utilities
• Pest control Checklist
• Segregation, zoning, logical flow of people and product
• No direct opening of toilets, labs and social areas to production area
• Floors drainable, no cracks or broken tiles,
• Cleanability and cleaniness of floors, walls, drains, ceilings
• Condition and state of repair
• Windows (shatter proof) and doors closed or screened
2. Inspection & Factory Visit
Factory Design & Lay-out
• Site & infrastructure
• Building design & lay-out
• Utilities
• Pest control
Checklist
• Heating, ventilation & air conditioning (HVAC) condition, over-
pressures, air flow
• Adequate and protected lighting
• Water source, quality, and treatment
• Steam (culinary)
• Air (oil & water free), filter type
• Approved lubricants
2. Inspection & Factory Visit
Water Sources Principal Supply
Towns/Municipal
Other Supply
Well / Bore Hole
Surface Water
Typical Process Water Treatment System
WATER SOFTENER
BREAK TANK
BACK FLOW PREVENTER
DE
PT
H F
ILT
ER
AC
TIV
AT
ED
CA
RB
ON
FIL
TE
R
CA
TIO
N E
XC
HA
NG
ER
CA
TIO
N P
OL
ISH
ER
AN
ION
EX
CH
AN
GE
R
MAINS
FEED
MAINS
FEED
MAINS WATER SOFTENED WATER DEMIN WATER
CHLORINATION AND STORAGE
Water Treatment Components Depth Filter
– For removal of suspended solids in water
Activated Carbon Filter – For removal of organic contaminants in water
– Recommended disinfection weekly once, e.g. 90oC water for 1 hour
Water Softening – For removal of ions which give rise to scale ( e.g. Mg, Ca replaced by Na )
– Recommended monthly disinfection, e.g. by 500ppm available chlorine for
up to 30 mins
Demineralisation – For removal of both anions and cations
– Resin bed regeneration (acid+alkali) kills majority of micro-organisms
– Recommended annual disinfection
– Size units to ensure frequent regeneration
Process Water Distribution System
Should Be : Capable of disinfection
Complies with hygienic design principles
EITHER :
Supply Ring Main Continuous circulation
No “dead-ends”
No stagnation
OR :
Drainable :-
Empty + dry
No storage of unchlorinated water
Process Water System Design
No
“Dead-Legs”
!!!!
Water Decontamination METHOD Positive Negative
Heat ( 60 to 80degC )
No chemicals, canbe part of the
process
Capital cost, high energy ( todestroy viruses/spores ), noresidual effect, cool water
again ?
Ultra-Violet( UV Lamp )
Effective against allmicro-organisms, no
chemicals
Need clear / uncoloured /water, clumps/biofilms not
treated, lamp maintenance,no residual effect
Micro Filtration Effective against allmicro-organisms
Grow-through can occurRequires monitoring and
maintenance
Ozonation Effective against allmicro-organisms
Capital and maintenancecosts can be high, no residual
effect
SodiumHypochlorite
Reliable, ResidualProtection, Cost
Effective
Chemical residue, Noteffective against spores at
2ppm, By-products
Chlorine Dioxide Effective against allmicro-organisms
As for Sodium HypochloriteHarmful gas
Factory Design & Lay-out
• Site & infrastructure
• Building design & lay-out
• Utilities
• Pest control
Checklist
• Pest access prevented
• Control system in place by professional 3rd party
• Position of executors
Personnel Hygiene
• Hand washing facilities
• Changing facilities
• Sanitary facilities
• Clothing
• Skills & capabilities
2. Inspection & Factory Visit
Product
• Raw material storage and handling
• Product handling
• Product/intermediates storage and holding
• Rework
• Packaging materials storage and handling
• Storage finished product
2. Inspection & Factory Visit
Packaging Materials Good Practices
•Toxicological safety clearance
•Keep stock levels to just-in-time wherever possible
•Ensure FIFO operates effectively with clear labelling
•Store in clean, dry, and dust free conditions on pallets
•Cover primary packaging
•Maintain good housekeeping, particularly on residual
materials returned from production
•Dispose of old stock
For Packaging Materials
Processing
Heat:
Hot process above 70oC can decontaminate if
process time is sufficient.
Some preservatives are deactivated by heat, pH
or other ingredients.
Order of Addition of Ingredients:
Effect of Process Conditions on Microbiological Quality
Processing Bad Practices
Vessel manway / lids left open
Flexible hoses poorly managed (on floor, in pools of liquid)
Standards of temporary modifications
Lack of disinfection after engineering work
Inadequate manual cleaning of equipment ( e.g. hoses )
Main plant trials not including assessment of how to control hygiene risks
Lack of awareness of risks and consequences
Some typical examples of bad practices are / have been :
Packing
• Simple hand filling operations
• Semi auto or fully automatic machines
• Weigh fillers
• Volumetric fillers
• “Flow meter” fillers
There are a wide range of packing machines in use:
Each type has a different set of risks
None provide positive benefits in the form of lethal steps
Packing Process Risks
• Supply headers for machines
• Pipework, valves, and flexible hoses
• Dosing valves
• Filler nozzles
• Spillage
• Condensation
• Dust generation
Typical risk areas in packing machines are :
The risks must be identified
AND
procedures put in place to manage these risks
Bulk, High Risk, Liquid Raw Materials
Transport Tankers must be cleaned & disinfected prior to use and certified as such
Receipt Reception points must be clearly labelled, clean, dry and terminal
connections covered by end caps
Hoses and pumps part of cleaning and disinfection programme
Storage Storage must be in stainless steel stock tanks of hygienic design
Aware of condensation risk is material ‘hot filled’, then cools on store
Inspection access is essential
CCP
CCP
Drum/IBC, High Risk, Liquid
Raw Materials Intermediate Bulk Containers / Drums
If reused by supplier, should be cleaned, disinfected and dried prior to
refill
Tops should be clean to avoid contamination of contents on opening
- environmental dust
- rainwater
Drum stores must be covered
Connections / pumps used to off-load to be part of C&D programme
CCP
CCP
Process Specifications / Recipes
Specify
Batch sheets (or control system) must:
Record
Orders of addition
Final pH specification
Batch temperature
Processing times
Deviations and reasons
Double checks for key raw
materials (e.g. preservative)
Includes all stages and unit operations :
- manual operations
- premixes
- main mix
Could be several CCPslinked to the process routes
e.g. correct dosing of preservative
Premixes / Intermediates
Pre-mixes and Intermediates must also be handled in a hygienically secure
way
If the pre-mix or intermediate is potentially vulnerable to contamination a
decision needs to be taken as to whether it will be made up fresh or stored
If a risk premix or intermediate is to be stored then physical protection (
temperature or pH mostly ) or chemical preservation will be required
Cleaning and disinfection procedures need to be carefully considered.
• Process
• Line lay-out
• P&ID verification
• Equipment & components design
• Process control & records
• Operational procedures (e.g.start-up, shut down)
• Packaging
• Maintenance & calibration
• CIP routing (hardware)
• Cleaning & Disinfection procedures
• HACCP
Checklist
• Dead-ends, T-pieces
• Verify type of equipment and check detailed design (technical drawing
evaluation of complex equipment) in case equipment is not approved
• State of repair and cleaniness of equipment, leaking couplings, valves, pumps,
damaged seals
• Calibration
• CIP system construction, double seat valves, chemical dosing correct, safe
separation of CIP-product
• Pasteurisation/sterilisation conditions adequate
• PHE/THE intact, flow diversion, cooling
• Pipe construction, welding, corrosion,
• Materials of construction
• Tank design, sprayballs construction.
2. Inspection & Factory Visit
Hygiene assessment
Checklist, Pasteurisation/Sterilisation unit\
• Type of product pump
• Kind of heat exchanger
• Regeneration
• Type and position of temperature probes
• Type of flow diversion valve
• Type of pressure sensors
• Flash vessel, how constructed
• Back pressure valves (types and place)
• Coupling types downstream heating unit
• Type of sampling valves
Hygiene assessment
Checklist, CIP
• P&ID; clear routes of CIP connections
• CIP documented, validated
• Valve seat flushing
• Valve seat lifting
• By-passes cleaned
• Dead-ends in product lines
• Clear cleaning loops and no dead ends
• Cleaning of drain valves
• Draining after cleaning
Checklist Plant & Equipmt
• Type and model of filling machine
• Cleaning procedures
• Pre-sterilisation procedures
• Type of sterilisation
• Air filters
• Spray nozzles
• Water quality, sterile water loop construction
• Mechanical seals construction
• Stop-start procedures
• Cleanliness of filler during production
• Construction of filling valves
• Commissioning & validation of filling machine
Hygiene assessment
Process line components
• Heating unit (PHE, THE, steam injector, steam infusion)
• Components; valves, couplings, pumps, sensors, etc.
• Cooling system (PHE, flash vessel)
• Aseptic tank, post-dosing
• Aseptic filler
• SIP/CIP system design & procedures
Valve Types and Cleaning
Type CIP Comments
Lip Seal (mix-proof) Yes Suitable for fully automated systems
Butterfly Yes Many types, plenty which are
cleanable
Rising Stem (tank base) Yes Care with very viscous materials or
trapped solids
Diaphragm Yes Must orientate to allow draining
Plug No Operational difficulties; can CIP if
substitute spool piece for valve
Ball No Material trapped in annulus between
ball and body - new types claim to be
hygienic ?
Pressure Relief Some Material trapped beyond seal in most
types
Non-Return Some Care on design to minimise hold up
and heat sanitising is recommended
Gate No Don’t use them !
Pump Types and Cleaning
Type CIP Breakdown Weak Hygienic Features
Cleaning
Lobe Yes Yes Some models have
crevices / poor rotor
attachment
Centrifugal Yes Yes Seals and impeller
shadowing
Double Diaphragm Yes Yes Peripheral seal is the weak
point
Diaphragm / Piston Yes No Non-return valves and seals
Peristaltic Yes No Care for cracked hoses
Rotary Vane Yes No Sliding vanes poor
Barrel / Drum No Yes Complex interior requires
flushing
Progressive Cavity No Yes Seals and poor draining
Sine No No Complex interior design
with sliding parts
Gear No No Seals and crevices
in intermeshing
gears
Heat Exchanger Types and Cleaning Heat Exchanger Comments Overall
Rating
Plate and Frame Hygienic designs available, must be single
pass and self draining. Tell tale for leaks is
desirable. CIPable given correct flowrates.
Scraped Surface Hygienic designs exist, need to look at
individual cases. CIPable, must run
scraper during cleaning.
Shell & Tube Hygienic designs exist, need to look at
individual cases. CIPable in principle, but
even flow not guaranteed in all tubes.
Spiral
(Longitudinal/Annular)
Fundamentally unhygienic due to seal
configuration. Not cleanable.
Preferred
Acceptable
Caution
when
selecting
Not
Acceptable
Heat Exchangers Types
T H A N K Y O U