Pathogenic Environmental Monitoring
Guarantee of chance of recontamination of food product cannot be given even after the effective application of HACCP and GMP. Even after following all required hygienic practices there are chances of recontamination of food with microbiological infestation, that might be due to addition of ingredient after kill treatment or from the processing room or from any other source. Microbiological contaminations can be either non-pathogenic or pathogenic microorganisms. Various pathogenic microorganisms such as E. coli, Listeria monocytogenes, and Salmonella spp. are potent contaminants in food-handling environments. Pathogenic Environmental monitoring prevent possible microbial contamination of food products by proper and scheduled monitoring for the presence of pathogenic microbes. It does not make food safe, rather, it helps in making systematic approach to reduce or eliminate pathogenic contamination in a timely manner.
The most effective tool for determining the effectiveness of a facility’s Salmonella controls is the implementation of an aggressive Pathogen Environmental Monitoring Program (PEM. A PEM is an on-going measure of the effectiveness of the overall Salmonella control program in the plant but it should be noted that it is not, in itself a Salmonella control program. It provides feedback on where efforts need to be directed for the overall control program. PEM Program should be designed in accordance to the requirement and process of facility as one size program does not fit all.
PEM: Requirement
- Team: For coming up with systematic approach there is requirement for a proper team which can look after whole program including setting up program, implementation and validation of the program at every fixed interval of time. It is important to have a team with mixed functionality. Team should consist of a team leader, quality manager, microbiologist, sanitation incharge, operations manager, plant engineer, maintenance head and line supervisor. All should have clear understanding of process and potential risks that can lead to pathogenic contamination.
- Hygienic zones of control assessment: To determine Primary Pathogen Control Area (PPCA) in facility there should be a hygienic zone assessment. Areas where post-lethality, treated/finished product is exposed to the environment they are marked as high hygiene or high risk area. Zoning is to identify areas of high and low risk to the product within the manufacturing operation and hence spreading of pathogens into the PPCA can be prevented, where protection of the exposed post-lethality product is critical. Hygiene zone assessment of the entire facility should be followed by creating a color-coded mapping of the facility.
During Hygiene zone assessment evaluation all production areas, storage, receiving, warehousing and loading docks, employee facilities such as cafeterias, break rooms, locker rooms, washrooms, maintenance areas, offices/conference rooms, etc. should be considered. Designating the PPCA, basic GMP areas, transition areas, and non-processing areas and paying particular attention to areas within the facility where ingredients, products, or the environment could be a potential source of Listeria, Salmonella and other pathogens and a high potential to re-contaminate post-lethality treated product. Non-process areas such as forklift charging stations, refuse/recycling areas, restrooms and others could also impact the PPCA.
- Sanitary Zoning:
In the sanitary zoning concept, the plant operations are divided into four zones based on level of risk.
Zone 1: Areas in plant that are direct product contact surfaces after the lethality or microbial reduction step (e.g. roaster) and before the product is sealed in the primary package. If there is no lethality step in the process – sites where the product is exposed to plant equipment and environment prior to sealing in the primary packaging, like conveyor belts/buckets, utensils, slicers/dicers, product hoppers/bins/bin liners, discharge chutes, fillers, air blowers and control buttons/switches
Zone 2: Non-product (near) contact areas in the plant that are closely adjacent to product contact surfaces like equipment exterior, under & equipment framework, drip pans/shields/housings, control panels/buttons, overhead lights, refrigeration unit’s/drip pans, conveyors, rail systems and pipes directly over zone 1 surfaces, computer screens, maintenance tools, drains located directly under equipment, motors located adjacent to lines
Zone 3: Non-product contact surfaces that are in open post-lethality product processing areas, but no closely adjacent to zone 1 surfaces. These surfaces have the possibility of leading to product recontamination like floors, walls, ceilings, hoses, pallets, drains, foot baths/ mats, brooms/ mops, condensate drip pans, trolleys, forklifts, walk-along, carts and toolboxes
Zone 4: Areas that are more remote from post lethality product processing areas. If these areas are not maintained in good hygienic condition can lead to cross-contamination of zone 1– 3 areas. These includes area like hallways, loading docks, bathrooms, locker rooms, employee cafeteria/break rooms, raw material coolers/freezers/Warehouses, maintenance shop and office areas.
Microbial Growth Niches
Locations, often “hard to reach” places, harboring the organism after the routine sanitation process for that area has been competed. Places within food processing equipment and/or a food processing environment where microorganisms become established and multiply serves as a reservoir from which microorganisms are dispersed and contaminate equipment during operation. Areas like behind O-rings, seals and gaskets on equipment and around doors (especially if old and brittle), spaces between metals, plastic joints and parts, chain guards, motor covers and housings, water-saturated insulation (e.g. in old spiral freezers, wrapped around pipes or behind fiberglass wall panels) can be serving as harborage area for microbial growth. Transfer Point are sites or carriers, such as employees and product handler’s gloves/clothing/boots, equipment or equipment parts, or maintenance tools, supplies and/or ingredients that may cross contaminate from one source to another prior to or during operations
Corrective action for Positive Results
In case of positive results facility should have a pre-determined action plan that would be implemented in the event of a Salmonella, Listeria positive result. The action plan should be specific for each of the four zones and include type of immediate corrective actions to be taken by zone, actions to be taken to verify Salmonella/Listeria has been eliminated from the area in question, a root cause analysis to find the source of the contamination so that it can be prevented in the future. In the event of a Pathogen (Salmonella/Listeria) positive, the response team should conduct an in-depth investigation looking at any maintenance disruptions/activities, in-plant construction, unplanned down time and other non-standard production activities (e.g. R&D plant trial)
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