Pathogen monitoring in Environment is a challenge in Food industry and is extremely important control mechanism to manage pathogens. have tried to highlight important aspects to be considered while implementing this program

1. Effective Implementation of PEM
Pathogen Environment Monitoring
Ganesh Kamath
3rd Dec 2014, Master Classes CII, New Delhi

2. To conclude, the take home message
is..
5 messages on PEM Program
 Understand the Intent
 Pre-requisites are backbone, know your mistakes
 Be sure of your target and sampling
 Listen to the data
 Manage Adverse events carefully

3. Understand the Program
 Is Finished food analysis good
enough?
◦ What criteria absent/g, /10g, /25g. /
5x25g???
 If so then why this statistics?
 Microbiology results are based on
sampling, probability, extent of
contamination, recovery etc
 So the Intent is
◦ Protect our Consumers
◦ Protect our Business
Number of cases of culture-confirmed bacterial and
laboratory-confirmed parasitic infection,
hospitalizations, and deaths, by pathogen —
Foodborne Diseases Active Surveillance Network,
United States, 2013*

4. Understand the Intent
 What is the intention of this program?
◦ To have a clean data?
◦ To have a clean manufacturing line?
◦ To pass the audits?
 The intent is
◦ To verify the effectiveness of certain prerequisite programs
implemented in the site to assure Microbiological Food
Safety
◦ To understand the cause of cross contamination
◦ To establish an early warning system
◦ To Hunt and Eliminate

5. Pre-requisites are backbone
When to implement the PEM program?
 Start with Pre-requisite programs First
◦ Zoning
◦ Pest Management
◦ Cleaning and Sanitation
◦ Maintenance practices
◦ Training and people practices

6. Mistakes in Zoning
 Do we know our Raw and
RTE Areas?
◦ Do we have controlled access
from exteriors
 Is our traffic under control?
◦ Do we move pallets between
Areas
◦ Do we move trolleys between
Areas
◦ Do we have transition zones
 How is the air flowing
between Areas?
 Are our buildings and roofs
ensure integrity to natural
forces?
 Is our Zoning in RTE
correct?
◦ Zone 1 / Zone 2 / Zone 3 /
Zone 4

7. Mistakes in Cleaning and Sanitation
 Dedicated cleaning tools in
Raw and RTE area
◦ Are they colour coded
 Dedicated tools for different
Zones in RTE area
◦ Are they colour coded
◦ Are these tools handled,
cleaned and sanitised
separately?
 Dedicated Vacuum cleaners
 Do we have dedicated
cleaning tools for drains
 Are our RTE areas
maintained Bone Dry during
production
 Cleaning of cleaning tools?

8. Mistakes in maintenance practices
 Breakdowns
◦ All rules are thrown out of
window!
 Sunday Maintenance
◦ GMP does not apply
◦ Microbiologist / Hygienist
on leave
◦ OEM, Contractors have
no idea about zoning and
PEM
 Practices
◦ Is separate maintenance
tools used for RTE zones
◦ What about cleaning after
maintenance activities?
RTE area Tools
Raw area Tools

9. Mistakes in People practices
 Transition zone bypass
◦ Rules are not for me!
 Cleaning practices
◦ Do it fast, we need to start
production
◦ Dry cleaning, what is that?
◦ Untrained contract labour does
the cleaning job
◦ Tool control, how does that
matter?
◦ Drains the most neglected part
of a factory
 Training and monitoring
program

10. Mistakes in Target Organism
 What is our Target Pathogen
◦ Salmonella, Listeria, E Coli?
◦ Not TPC, Coliforms and Y&M
◦ Sole dependence of Target Pathogen?
 Do we use Indicator organism
◦ Enterobacteriaceae (EB)
◦ Do we have action limits? Root cause analysis and
Corrective actions?
 Where do we sample
◦ Line>Zone 1>Zone2>Zone3>Zone4?
◦ Raw Area?

11. Mistakes in sampling
 Are we using the right
tools and techniques?
 Targeting conformance!
◦ Sample after cleaning
◦ Sample the same spot
over and again
 Mostly missed hot spots
◦ Focus on items that cross
transitions zones (Pallets,
forklift wheels, shoes)
◦ Dust bins, Vacuum
cleaners
◦ Hunting for dirty, hidden,
moist, hard to reach

12. Mistakes in data analysis
 Trends… Why?
 Do we know the hot
spots?
 Can we trace the exact
root cause of cross
contamination
Major
Maintenance
Cross
contamination
Improper
cleaning

13. Adverse Event Management
 What is an adverse event?
◦ Roof leakage
◦ Un controlled water in RTE area
◦ Drain back off etc
 What should you do?
◦ Isolate the area
◦ Take control of incriminated products
◦ Clean and Disinfect
◦ Verify with extensive sampling (Line, Environment &
Products)
◦ Start production
◦ Monitor at an escalated level

14. To conclude, the take home message
is..
5 messages on PEM Program
 Understand the Intent
 Pre-requisites are backbone, Know your mistakes
 Be sure of your target and sampling
 Listen to the data
 Manage Adverse events carefully

15. QUESTIONS?
Thank You