fsma training: environmental monitoring - web-fs.s3 …€¦ · • days 1, 2, 3 - of 33 swabs...
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Environmental Monitoring
FSMA TRAINING:
ENVIRONMENTAL MONITORING
Environmental Monitoring
Deann Akins-Lewenthal - ConAgra
Listeria Monitoring:
Frozen Food Industry
Environmental Monitoring EMPC- Whole Genome Sequencing
Challenges in manufacturing environments have led to new opportunities to use Next Generation Tools
• Whole Genome Sequencing reveals the DNA makeup of organisms
• Determine persistence of pathogens in environments and help to drive towards root cause and appropriate corrective actions
Two examples of using WGS with Environmental Listeria spp.
• Both manufacturing facilities produce products that don’t support the growth of Listeria spp.
Environmental Monitoring Plant 1: Driving Change with
New Tools
• 2 drains in the roasting room reported as positive for Listeria species; CA
and vectoring began
• Vectors + and investigative swabbing showed many floor sites were positive
• Multiple re-cleanings and verification swabs collected
• Roasting commenced and operational swabs taken
• Days 1, 2, 3 - Of 33 swabs taken each time: 6, 29, 17 consecutive positives
Environmental Monitoring Timeline cont.
Full clean, chlorinated floor (1,800 ppm)
10 swab results were +
2 frame sites +
Increased chlorine ppm on floor (2,000 ppm)
40 swab results were NEGATIVE
Days 1, 2 – Of 31 swabs taken: 10, 22 consecutive positives
Later, another full clean and chlorine flood >2000 ppm.
3 of 33 swabs were +
Finally, swabbed inside bearings
and found them positive
(Total period of about three months)
Vector and investigative swabbing
indicated corrective actions were not
successful
Environmental Monitoring Whole Genome Sequencing…
WGS performed on 66 isolates recovered
from Roaster room
isolates with 98% similarity with Listeria innocua 54
isolate grouped with Listeria marthii 1
isolates atypical for Listeria species 11
Environmental Monitoring Outcome
Sanitary design modifications initiated once harborage site identified
New sealed bearings Removed the sandwich
areas for the legs Made cut-outs for clean-
ability
Environmental Monitoring Example 2
Routine EMP program was initiated by Enterprise Microbiology
First positives detected, 2nd set of follow up swabs showed
few Listeria spp. positive
Additional CA’s were performed. Follow-up swabs were negative
During routine swabbing, Listeria positives were detected again, CA’s were
performed, 2nd set of follow-up swabs detected few Listeria spp. positives
Increased Swabbing was performed, 34 positives were detected. Line was
shut down, Corporate team was involved and an action plan was
proposed. Plan included: (1) WGS analysis of the isolates (2) Change in
sanitation practices (3) Capital improvements and (4) Traffic controls
Root-cause found and fixed. 3 months of negative results. Plant continues
to implement best practices identified during the root-cause investigation
process
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Environmental Monitoring Example 2
Environmental Monitoring
Maintenance Cart was going to/from outside of
the facility to production areas
Group 1 Listeria spp. Group 2 Listeria spp.
Environmental Monitoring Key Accomplishments
Re-surfaced the floors where the Listeria was detected and in the sanitation room
Listeria spp. harborage sources (ex: cracks in floors) were sealed
Roll-up door was removed and replaced with a wall
Restricted usage of water-DRY CLEANING AND SANITATION ONLY
Re-designed traffic controls
Instituted foot sanitation for employees before entering into the area
Environmental Monitoring Take Home Message
A robust EMPC program is designed
to find potential pathogens and eliminate them.
Seek and Destroy
Definitions of EMPC terms may not be universal to all of industry; Ask for
clarity
Routine versus investigational,
zones
Important to focus on the corrective action
plan and follow through after a
suspect result is determined.
WGS will not be used in every
situation.
Resolution does not happen over night.
Environmental Monitoring Acknowledgments
Joan Menke
Steve Hermansky, Ph.D.
Bala Kottapalli, Ph.D.
Nancy Dobmeier
Brad Ziebell