Document No.

NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 1 of 8

DOCUMENT NUMBER
NSPL/QAC/P/04

DOCUMENT NAME
ENVIRONMENTAL PATHOGEN TESTING PROGRAMME

DATE REVISION

PREPARED BY: BASAVARAJ

APPROVED BY: YAGNASREE

Objective

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 2 of 8

To ensure food produced is free from pathogens

Scope
It provides guidance and measures the overall effectiveness of sanitary design,
personnel practices, and operational methods.
Environmental Pathogen Testing Program (EPTP):
Pathogenic microorganisms such as Listeria monocytogenes and Salmonellaspp.
have well-established histories of being potential contaminants in food•handling
environments. Hence, it is critical to monitor the hygienic environment in the
food manufacturing facility for the production of high quality and safe food
products. An environmental pathogen testing program (EPTP) will assess the
effectiveness of the overall hygienic practices in a facility and provide necessary
information to prevent possible microbial contamination of food products
EPTP Benefits:
Measures the overall effectiveness of sanitary design, personnel practices, and
operational methods. Provides information (source and concentration) about
indicator organisms, spoilage organisms, and/or pathogens of concern in a timely
manner, so that appropriate corrective actions can be initiated to prevent potential
microbial outbreaks. Acts as an early warning system for microbiological hazard. in
both the production and post-production environment when well-developed and
effectively implemented as an integral component of prerequisite programs. Helps to
identify harbourage niches and hot spot in a plant that may act as a source of
contamination. Is critical aspect of documenting the overall sanitary condition of
facility.
EPTP Process:
• To implement EPTP effectively we need to bring together individuals familiar with
the operation to help identify potential areas of risk and concern in a facility. This
group will be the EPTP team and may include the plant quality manager, the plant or
corporate microbiologist, line supervisors or operators, and sanitation supervisors or
workers.
•An EPTP should be carefully designed after evaluating the facility and its products.
Different food plants with various food products may require different EPTPs. An
EPTP is specific to a facility and to the individual operations within a facility.
•A tailored environmental monitoring program with a baseline/target will be more
specific as well as more effective in assessing the overall sanitary conditions of the
facility.

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 3 of 8

•It is critical for the ETP team to define what constitutes highest risk areas (zone 1) to
lowest risk areas (zone 4) for product contamination in a facility. Also, it is important
to choose the right testing fools and methods before beginning to collect samples.
Seek and Destroy
Environmental pathogen program is counterintuitive to many people because
while the overall food safety goal is to maintain critical processing areas free of
the pathogen, the goal of environmental pathogen program is to find these
organisms.
A successful program diligently tries to find the organism and addresses issues
identified.

Sampling Plan - Written SOPs for Environmental Pathogen Program

Set a baseline, link that with your sampling plan, and establish testing
frequency once you have finalized the number of samples and zones. It is critical
to have clear written SOPs for environmental pathogen programs to reduce
errors and they shallinclude the following:
□ Frequency of sampling: higher frequency as closer to zone 1, for
example: weekly zone 2/3 and monthly zone 4
□ When, where, how and duration of sampling: sampling sites should not
be random but target the mostlikely sites to harbour the organism of
concern;
□ Procedure for recording data and coding;
□ Sample number, size or volume;
□ Specific sampling and analysis validated protocols;
□ Monitoring of incubators and use of equipment;
□ Handling and shipping of samples; and
□ Alert and action levels and appropriate response to deviations from alert
or action levels.
 It is important that personnel performing environmental pathogen
program are trained and validated. Each individual needs to
demonstrate proficiency of doing it. It is important that sampler
understand proper recording of environmental pathogen program
data, alert and action levels, and zero tolerance levels. Personnel
must be comfortable and qualified for sampling protocol and using
the equipment.

To establish Critical Zones:

 Survey entire facility and have amap of the facility.

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 4 of 8

 Study that map and identify traffic patterns to divide the facility into critical
hygiene zones, GMP zones, and non-processing zones.
 Put in place barriers between these zones and dedicate equipment to the
critical hygiene zone, and restrict access between zones.
 Establish strict cleaning, sanitation and monitoring plans for these diff zones.
 Which tests will be done, and in which zones; Choose the right test methods.

Fig 2: Namdhari Seeds Pvt Ltd Zone Mapping

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 5 of 8

DESCRIPTION OF ENVIRONMENTAL SAMPLING ZONES.

Environmental sampling sites are defined by “zones”; classifications of sampling sites
based on risk of contamination and proximity to product contact

Zone - 1 All direct food contact surfaces in the plant (e.g., Cutting
machine, Centrifuges, Dryers, utensils, work tables, etc.).
Zone - 2 Nonfood contact areas in the plant that are closely adjacent to product contact surfaces.
In general, this is the area where environmental contamination is most likely to
affect the safety of the product (e.g., equipment framework, maintenance tools, drip
shields, housings, etc.).

Nonfood contact surfaces those are not close to zone 1. If zone 3 is contaminated with
Zone - 3
a pathogen, it could lead to contamination of zone 2 through employees' actions or
movement of machinery (e.g., walls, floor, drains, etc.).
Areas remote from the product processing areas if zone 4 is not maintained in a good
Zone -4
sanitary condition, it can lead to cross contamination of zones 1, 2, 3 ( eg: office areas
locker rooms, maintenance room etc.
Sample Collection:
Mapping:
A map of all sampling locations on a facility design diagram is an effective way
of identifying hot spots to take appropriate corrective actions. Mapping helps in
identifying harborage niches and hot spots that may act as a source of
contamination.

Sample Collection:
Samplers must practice good hygiene:
Wash/ Sanitize hands.
Put on sterile gloves before handling swab.
Change gloves/ sanitize between swabs.
The area sampled can vary from: 40 t0 200 in 2 for indicators. 40 t0 400 in2 for
pathogens.
Wipe Zone-1 based sample sights with alcohol based sanitizer after sampling.
Submit samples promptly.

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 6 of 8

Sampling Frequency /Plan

Product Contact
Proximity Site Locations Potential Targets Timing
Zone 1 Conveyors, slicers, mixers, utensils, product Aerobic Plate Count Pre-operation;
Direct/Indirect Coliform Yeast/Mold
tanks/vats, overhead fixtures/pipes
Product Contact Enterobacteriaceae
Lactic Acid Bacteria After sanitation but before
start of production
Conveyor frames, equipment handles, Aerobic Plate Count Coliform Pre-operation; After
Zone 2 Areas adjacent to shields and guards, controller buttons, Yeast/Mold Enterobacteriaceae sanitation but before
Zone 1 sites maintenance tools Lactic Acid Bacteria Salmonella start of production
spp. Listeria spp. Listeria
monocytogenes Staphylococcus
aureus
Drains, walls, undersides of tables and Salmonella spp.Listeria spp. At least 3 hours into
Zone 3 Non-Product
Contact within equipment, hollow legs of equipment, Listeria monocytogenes production shift
cart wheels, trash receptacles, lifts, Staphylococcus aureus
Protected areas
pallets
Outside Protected Break rooms, restrooms, locker rooms, Salmonella spp. At least 3 hours into
Zone 4
Areas warehouses, shipping/receiving Listeria spp. production shift
Corrective Actions:
Positive Zone I:
• Stop production in the affected line.
• Stop product.
• Thoroughly examine the area, both visually and through vector
swabbing.
• Breakdown production lines for inspection and take appropriate
corrective actions (e.g., leakage, employee traffic, etc.).
• Thoroughly clean affected site (SO-foot radius) and swab site and
adjacent areas (zones 2 and 3).
• Increase sampling frequency until you get three consecutive negative
results.
B. Positive Zone 2:
• Breakdown production lines for inspection.
• Restrict traffic flow in these areas to the extent possible.
• Thoroughly examine the area, both visually and through vector swabbing.
• Take appropriate corrective actions (e.g., leakage, employee traffic, etc.).
• Collect swabs after thorough cleaning (zones 2 and 3) in a 50-foot radius.
• Increase sampling frequency until you get three consecutive negative results.
• Zone I swabbing and/or finished product testing may need to be initiated or
intensified in the event of persistent zone.

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 7 of 8

C. Positive Zone 3 and Negative Zone 2:

This is an early indication that the cleaning and sanitation programs need to be more
robust or redesigned.
•Restrict traffic flow in these areas to the extent possible.
• Thoroughly examine the area.
• Collect swabs after thorough cleaning (zone 3) in a 50-foot radius.
• Increase sampling frequency (e.g., from weekly to daily) until you get three
consecutive negative results.
D. Positive Zone 2 & Zone 3:
• Break down production lines for inspection.
• Restrict traffic flow in these areas to the extent possible.
• Thoroughly examine the area both visually and through vector swabbing.
• Take appropriate corrective actions (e.g., leakage, employee traffic, etc.).
• Collect swabs after thorough cleaning (zones 2 and 3) in a 50-foot radius.
• Increase sampling frequency (e.g., from weekly to daily) until you get three
consecutive negative results in zones 2 and 3.
• Zone I swabbing and/or finished product testing may need to be initiated or
intensified in the event of persistent zone 2 positives.

Action Plan In Case of Positive Results:

A. Assemble EPTP team.
B. Initiate root-cause investigation. (What happened?)
C. Use the team's findings to improve operations, such as:
• Thoroughly examine the area, both visually and through vector swabbing.
• Increase cleaning and sanitation frequency.
• Re- examine employee traffic patterns and redirect, if feasible.
• Make repairs (e.g., leaks, cracks etc.).
• Audit production handling practices (e.g., product and material handling, etc.).

Confidential- Do not copy or distribute without prior consent from

 Document No. NSPL/QAC/P/04

ENVIRONMENTAL PATHOGEN Date of Issue 01.03.2021

TESTING PROGRAMME
Namdhari Seeds Pvt Ltd Version 1.00
Procedure Page No. 8 of 8

• Redesign and/or perform equipment maintenance as needed to eliminate

harbourage niches that may act as a source of contamination
or facilitate cleaning access.
• Conduct indirect cleaning such as floor scrubbing and sanitation or cleaning
of overhead equipment, A/C ducts and pipes, etc.
• Increase the swab frequencies.
• Verify the effectiveness.
• Monitor and document.

EPTP team members

Unit head: Mrs Yagnasree
Quality: Basavaraj
Maintenance: Mr. Venkat Naidu
Production: Mr. Pruthvi Manas
Stores and Dispatch: Mr. Srinivas and Mr. Rajashekar, Mr. Sai Manas
Housekeeping team: Mrs. Lakshmi, Mrs. Jyothi

Confidential- Do not copy or distribute without prior consent from