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How to Set Up Sampling Zone for

an Environmental Monitoring
Program

©Copyright AIB International


May not be reproduced without written permission.
Introduction
• Kantha Channaiah, Ph.D.
Director of Microbiology
• Webinar: 45 minutes
• Q&A session: 15 minutes
• Please hold your questions until the end of the
webinar
• Questions can be entered via the Q&A widget on
the right-hand side of your screen
Agenda
• Food Safety - Importance
• What is a Hygienic Zoning?
• Why do we need Hygienic Zoning?
• Objectives of Hygienic Zoning
• Application of Hygienic Zoning
• Hygienic Zoning for an Effective Environmental Monitoring Program
• Summary
• Q&A
Food Safety: Top Priority
• The food processing environment plays an
important role in food safety
• Microorganisms can enter the food processing
environment through different routes
• The Good Hygienic Practice is critical to achieve
food safety (ICMSF)

ICMSF: International Commission on Microbiological Specifications for Foods


Cross-Contamination & Food Safety
• Each year foodborne illness outbreaks affect
millions of people & kill thousands
• Cross-contamination
is one of the frequent causes and sources
• It is critical to implement hygienic zoning in a
food establishment
Why Do We Need Hygienic Zoning?
• To differentiate areas within a
facility to minimize product
cross-contamination
• Hygiene zoning plays an
important role in reducing or
excluding:
– Microorganisms
– Chemicals
– Physical agents
How to Achieve Food Safety?

Cleaning
Hygiene GMPs &
HACCP
Preventive
& EMP
Food
Zoning SOPs Controls
Safety
Sanitation

Hygiene Zoning is one of the Pillars of Food Safety Program


What is a Hygienic Zone?
• A designated production area in a food
establishment
• Classifies the individual production areas by
their hygiene risk and demands the specific
functions and hygiene standards
Objectives of Hygienic Zoning
1. To identify and separate high and low
risk areas within a plant environment,
and
2. To protect cross-contamination of
product and the process
Hygienic Zoning – Assessment & Considerations
• Conduct Environmental Risk Assessment
– Infrastructure
– Identify the sources of contamination
e.g., dust, air, water droplets, employee, raw ingredients, equipment
(forklift), etc.
– Identify the cross over areas
– Check the history of that place
– Review the cleaning & sanitation records
– Create a color-coded zones/ map
Applying Hygienic Zoning in a Food Plant
1. Determine what constitutes the Primary
Pathogen Control Area (PPCA)
2. Designate basic GMP areas, transition
areas, and non-processing areas using a
color coded map
3. Demark those areas that require strict
hygiene rules, and
4. Decide on the rules (including employee
traffic) that need to be applied in each
segregated zones
Hygienic Zoning
Non-
manufacturing
zones

Transition
areas
Basic
GMP
areas

Primary
pathogen
control
areas
Example: Hygienic Zoning

Primary Pathogen
Zone 1 Zone 3 Basic GMP
Control Area
Non-
Zone 2 Transition Zone 4 Manufacturing
Hygienic Zoning - Guidelines
• All manufacturing activities must take place in the appropriate areas or
zones e.g., Zone 1/ 2/ 3/ 4.
• Wherever possible highly sensitive areas should be separated by a
physical barrier to avoid cross-contamination
• Have dedicated employees in each zone(s) to achieve highest food
safety throughout the process
• Determine each zone(s) specific cleaning & monitoring requirements
• Monitor & verify
Hygienic Zoning Levels - Guidelines
• Not all food production plants require
exactly 4 hygienic zones
• Some plants require only 2/ 3/ 4
depending on the nature of the
finished product, HACCP plant, and
risk analysis
Hygienic Zoning - Controlling Traffic Pattern

Controlling raw
ingredient, equipment,
and employee traffic
pattern is key to prevent
cross-contamination

A place for everything and everything in its place


- Benjamin Franklin
Product Flow is the Key to Success
• Establishing a correct traffic pattern is critical for food safety
Hygienic Zoning and Food Safety
The SUCCESS of hygienic zoning depends on:
• GMPs
• Cleaning & sanitation program
• Employee hygiene practices
• Pest control program
• Process validation
• Good hygiene post-process handling
• SOPs
 Red brushes & containers: Used for raw products
 White brushes & Containers: Used for cooked food and FCS
 Purple brushes & Containers: Used for Zone II areas
 Yellow Brushes & Containers: Used for Zone III areas
 Black Brushes & Containers: Used for drains only
Requirements: Common GMP Zones
• SOP and Physical Barriers
– Handwashing
– Footwear/ boot sanitation
– Hairnet and beard net
– Safety gadgets: Glasses, ear plugs
– Jewelry policy
– Eating/ drinking policy
– Sick employee policy
Requirements: High Sensitive Zones
• SOP and Physical Barriers:
– Walls and locked doors
– Restricted access
– Air balancing
– Hygiene Entrance Area: people
– Hygiene Transfer Area: materials &
equipment
Hygienic Zoning for an Effective Environmental
Monitoring Program
Utilize the Hygienic Zoning Concept
• Based on the hygienic zoning concept, divided the facility in to 2/3/4
zones
• The number of environmental swabs depends on the hygiene zones and
the nature of the finished products
A proper hygienic
zoning is the
foundation for an
effective
environmental
monitoring program
What Does FDA-FSMA Say?
• A facility, as appropriate to the facility, the
food, and the nature of the preventive
control, must conduct environmental
monitoring and product testing if:
– A ready-to-eat (“RTE”) food product is
exposed to the environment before it is
packaged Environmental swab
– The packaged food does not receive a and product tests:
treatment that would significantly Verification activity
minimize an environmental pathogen
• EMP is not designed to validate the effectiveness of cleaning and
sanitizing methods, but is more focused on validating cleaning and
sanitizing frequencies, and all the programs of the Good
Manufacturing Practices (21 CFR).
Polling Question
Why it is recommended to test zone 1 for indicator microorganism?

Why not for pathogens?


Polling Question - Answer
Why it is recommended to test zone 1 for indicator microorganism?

Why not for pathogens?

It is recommended not to swab for pathogens in a zone 1 environment as


this is not an effective way to capture product contamination. Also, if zone
1 tests positive, then it will most likely initiate a recall situation.
Zone
1

• All direct food contact surfaces in the plant (blenders, conveyors,


utensils, work tables, etc.)
• Zone 1 is the most sensitive to contamination
• It is recommended not to swab for pathogens in zone 1 areas
• It is highly recommended to test zone 1 for indicator
microorganism
Environmental Swabs in Zone 1 Areas
Total percentage of
testing from zone 1
is normally
10-20%
Polling Question
What is the percentage of swabs that we need to collect from zone 2
areas?
Polling Question - Answer
What is the percentage of swabs that we need to collect from zone 2
areas?

About 40-50% of total swabs, because this is the area in which


environmental contamination is most likely to affect the safety of the
product
Zone
2

• Non-food contact areas in the plant that are closely adjacent


to food contact surfaces (equipment frame, maintenance
tools, drip shields, chain-guard housings, etc.)
• Area in which environmental contamination is most likely to
affect the safety of the product
• It is recommended to test zone 2 areas for indicators as well as
pathogens
Environmental Swabs in Zone 2 Areas
Total percentage of
testing from
zone 2 is normally
40-50%
Polling Question
What is the indicator bacteria for Salmonella?
Polling Question - Answer
What is the indicator bacteria for Salmonella?

Enterobacteriaceae
Zone
3

• Non-food contact surfaces that are not close to zone 1 surfaces (walls,
floors, drains, ceilings, pallets, etc.)
• Don’t forget to include wheels!
• It is recommended to test zone 3 areas for indicator as well as pathogens
– E.g., Enterobacteriaceae for Salmonella spp.
– Listeria spp. for Listeria monocytogenes
• If zone 3 is contaminated with a pathogen, it could lead to
contamination of zone 2
Environmental Swabs in Zone 3 Areas
Total percentage of
testing from
zone 3 is normally
30-40%
Zone
4

• Refers to the areas remote from the product-processing areas


(employee break area, office area, maintenance room, etc.)
• If zone 4 is not maintained in a good hygienic condition, it can lead
to cross-contamination of zones 3, 2, and 1
• In general, zone 4 is tested for indicator microorganism
Environmental Swabs in Zone 4 Areas
Total percentage
of testing from
zone 4 is normally
<10%
Polling Question
What is the best method to collect air samples?
Polling Question - Answer
What is the best method to collect air samples?

Recommend using hand held portable air sampler.


E.g., SAS Super 100 Microbial Air Sampler, 100 L/min

Note: AIB International does not endorse third party products and services
Comprehensive Environmental Monitoring Program (EMP)

• EMP plan:
– Hygienic zones (1-4 zones)
– Water: All water sources
– Air: Collect air samples (E.g., air sampler
100L/min)
– Employees: E.g., Hands, boots, cloth
– Product testing: Raw ingredients &
finished product
Verification
• Periodically verify your written
environmental monitoring procedures
by increased and intensive
environmental sampling of the plant to
assess whether the hygienic sampling
sites are appropriate
(FDA 2017)
Summary
• Prevents cross-contamination
• Eliminates product held-up
• Designing products flow is the key to success
• Reduces the downtime required for an item of process equipment to be
cleaned
• Reduce the likelihood of post-lethality cross-contamination
• Helps in building an effective EMP
• Hygiene zoning helps facility prioritize/ optimize sanitation program
Questions
Thank You