Effective Implementation of PEMPathogen Environment Monitoring

Ganesh Kamath

3rd Dec 2014, Master Classes CII, New Delhi

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

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*

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

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

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

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?

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

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

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?

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

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

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

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

QUESTIONS?

Thank You