KANDHARI BEVERAGES PVT LTD.

SAMBA KBN/SOP/QA/13

Quality System Procedure Issue No: 01

Environment Monitoring Program Date of Issue: 10.06.23

1. PURPOSE: - Environmental monitoring programs (EMP) to support manufacturing facilities in

finding and eliminating any residential pathogens and/or spoilage microorganisms of concern in
processing zones.

2. SCOPE: These requirements apply to all operations manufacturing for/or on behalf of The Coca-
Cola Company. This requirement does not cover cleaning and testing outlined in BP-RQ-750 Cleaning
and Sanitizing.

3. Responsibility: Microbiologist/ QA Manager

4. Zoning:
Hygienic zoning and product proximity zones in the manufacturing facility are divided into four zones
based on risk assessment are as following:

ZONES-1 (Food Contact Surface)

Contact or may contact product e.g. (Filler, Mixing Trolley, Pulp Cutting
Equipment, Filler Enclosure, Sugar Dumping Hopper, Closure/Preform
Hopper, Scoops, Bucket, Preform/Closure conveyors, Gloves, Food-
Handlers, etc.)

ZONE-2 (Non-Food Contact Surface)

Near to food, contact surfaces (Processing equipment exterior and
framework, equipment control panels, switches) Sites where the potential
risk of transfer of contamination to exposed food exists equipment and
framework. In General, this is the Area Where Environmental
Contamination is Most Likely to Affect the Safety of the Product (e.g.,
Equipment Framework, Conveyor Belt, Filler Base Plate, Tank Outer side, Water Hose,
Concentrate Storage, Hand Trolley in Syrup Room, Homogenizer, Filler Room Table,
Maintenance Tools, Drip Shields, Housings, Guides and Star-Wheels etc.).

Prepared by Microbiologist
Approved by QA Manager
Classified: “Internal Use Only”
 KANDHARI BEVERAGES PVT LTD. SAMBA KBN/SOP/QA/13

Quality System Procedure Issue No: 01

Environment Monitoring Program Date of Issue: 10.06.23

ZONE-3 (Non-Food Contact Surface)

Remote from food contact surfaces located near processing area Sites
surrounding Zone 2 that could transfer contamination to Zone 2 and Zone 1 (e.g:
floors, walls, drains, ventilation HVAC, overhead piping, forklifts, doorways,
Lockers, Maintenance Workshop equipment, Pallets, etc.).

ZONE-4 (Non-Food Contact Surface)

Non-Manufacturing areas, Sites away from food production areas: If Zone
4th is not Maintained in a Good Sanitary Condition, It Can Lead to Cross
Contamination of Zones 1, 2, and 3 (e.g.- Door, Locker, Handles, Platforms
etc. warehouse Rack, Loading way etc.).

5. Sampling Frequency:
1. Sample should be taken as per defined sampling plan & procedure- KBN/SOP/QA/13/04
2. High Risk areas must be sampled at a higher frequency.
3. Sampling must be conducted at different days of the week to get full information about the
production cycle. Consider seasonal changes if expected to have higher contamination or
micro growth in some seasons rather than others
4. Schedule different production shifts if there is production operation or the location is on
Stoppage mode
5. Positive results must trigger investigational extensive sampling as part of corrective actions.

6. Sampling procedure
The sampling approach depends on the based on the facility zoning and general hygienic situation

Surface swabbing
 Carefully Remove the Cap from the Pre-Moistened Sterile Cotton Swab.
 Thoroughly Swab a Standard Sample Rotating the Swab as the Sample is Being Collected.
 After Swabbing the Test Area, carefully Place the Swab into the Tube. If the Swab Cannot
Be transferred immediately, return it to its Holding Tube and Store in a Cool Place.
 Prepare the Plates by Membrane Filtration Method.

Prepared by Microbiologist
Approved by QA Manager
Classified: “Internal Use Only”
 KANDHARI BEVERAGES PVT LTD. SAMBA KBN/SOP/QA/13

Quality System Procedure Issue No: 01

Environment Monitoring Program Date of Issue: 10.06.23

 For Membrane Filtration, Dilute the Amount of the Sample According to Specification with
a Minimum of One-Part Sample to three Parts of Sterile Distilled or Deionized Water.
 Invert and incubate all the Plates at 25⁰C for 120hrs for Yeast & Mold, 36⁰C for 48hrs for
TPC & Enterobacteriaceae.
 After Incubation, Count the Number of CFU Formed on the Plates with the Help of Colony
Counter and Record the Results.

Air Testing
For routine monitoring, target microorganisms for all products are:
Air volume to be taken is 1m3.
(1) Total viable count
(2) Yeast and molds

Sampling priority and split of numbers of samples of spoilage and hygiene indicators
Product Proximity
Food
Contact Non-Food Contact
Zone risk Surface
classification/ Percentage Surface
Proximity to (%) of total Zone 1 (Z1) Zone 2 (Z2) (close to Zone 3 (Z3) (walls, drains, Zone 4 (Z4) (non-
product samples (product PCS) HVAC, uniforms, shoes) manufacturing
contact areas)
surfaces
(PCS))
Surface
High Risk 50%** >30%* N/A
Surface Surface

Air N/A
>50%* Air >20%* Air

80% 20%
Surface
Medium Risk 30%** >30%* Trouble shooting
Surface Surface

Air N/A
>50%* Air >20%* Air

80%* 20%*
Surface: N/A Surface: 100%
Low Risk 20%** Trouble shooting
Air N/A Air 100% Investigational sampling

Prepared by Microbiologist
Approved by QA Manager
Classified: “Internal Use Only”
 KANDHARI BEVERAGES PVT LTD. SAMBA KBN/SOP/QA/13

Quality System Procedure Issue No: 01

Environment Monitoring Program Date of Issue: 10.06.23

Note:
RED: High Priority, Routine Sampling
Orange (zone 2&3): Medium Priority, Routine
Sampling, Less Frequency
Green: Low Priority, Investigational Sampling for
Tracking Potential harborage niches.

7. Verification of sampling:
The relevance of schedule and sampling scheme must be regularly verified (based on trend analysis
and additional investigation sampling) to make sure that the monitoring remains dynamic and do not
provide a false sense of security.

8. Corrective actions

The following are key considerations relative to taking proper corrective actions:

 Investigation/troubleshooting sampling
 Use Swabbathon to establish baseline or to understand full scope of the contamination
 Use Vector swabbing to investigate the source and the spreading of contamination. Establish
vectors in all directions
 All corrective actions, including additional sample results, need to be properly
documented.
 An analysis to find the root cause of the contamination so that it can be prevented in
the future
 The specific corrective actions to be taken based on the zones and an assessment of
the likelihood of finished-product contamination.
 The three samples must be taken consecutively following the receipt of the previous
sample result (i.e. when the first result is received the second sample shall be taken).

13. Definitions
Prepared by Microbiologist
Approved by QA Manager
Classified: “Internal Use Only”
 KANDHARI BEVERAGES PVT LTD. SAMBA KBN/SOP/QA/13

Quality System Procedure Issue No: 01

Environment Monitoring Program Date of Issue: 10.06.23

Type of cleaning:

• Wet cleaning – the removal of soil, including food residues, dirt, grease or other objectionable
matter using water and detergents.
• Controlled wet cleaning – the removal of soil, including food residues, dirt, grease or other
objectionable matter using a limited amount of water and detergents and controlling the spread
of the water used.
• Dry cleaning – the removal of soil, including food residues, dirt, grease or other objectionable
matter by actions such as wiping, sweeping, brushing, scraping, or vacuuming the residues
without the use of water and detergents.

Hygienic zoning refers to the GMPs in place and risk associated with each processing area.
Direct product contact surfaces (PCS) are surfaces exposed to product during normal equipment
operation.

Indirect product contact surfaces are surfaces from which liquids or dust or other material may
drain, drop, diffuse, or be drawn into the product or into the container, and surfaces that touch
product contact surfaces or the product container

Product proximity i.e. where environmental samples are collected according to the potential for
contamination in relation to the areas in which where food is being processed (zoning) with a
clear difference between Food Contact Surfaces and Non-Food Contact Surfaces.

Alarm level in microbiological environmental monitoring is that level of microorganisms that

when exceeded, it requires immediate follow-up and corrective action. Alarm levels are usually
based on historical data gained during routine operation of the processes in the specific hygienic
zones.

Swabathon – environmental extensive swabbing of surfaces when investigators collect at least 50

and possibly 100-400 samples over 1 or more days, from different hygienic zones to establish
baseline or ensure there are no pathogenic nor spoilage microbes that can contaminate final
product.

Vector swabbing is used to identify the original source of contamination and all surrounding
locations that might be contaminated Grid off the surrounding areas and systematically conduct
intensified swabbing.

Prepared by Microbiologist
Approved by QA Manager
Classified: “Internal Use Only”
 KANDHARI BEVERAGES PVT LTD. SAMBA KBN/SOP/QA/13

Quality System Procedure Issue No: 01

Environment Monitoring Program Date of Issue: 10.06.23

13. Associated documents

1. Product Risk Assessment KBN/SOP/QA/13/01

2. Plant zoning Risk Assessment KBN/SOP/QA/13/02

3. EMP MAP KBN/SOP/QA/13/03

4. EMP Sampling plan KBN/SOP/QA/13/04

5. EMP Trends KBN/SOP/QA/13/05

Prepared by Microbiologist
Approved by QA Manager
Classified: “Internal Use Only”