Hygienic zoning is a plan that identifies and enables the required level of protection and care for the product. It involves zoning risk assessment, zoning plan and zoning verification. It is to determine the area that can be source of microbial or chemical contamination and to prevent it passing to production area. Hygienic zoning is created within facility based on risk of cross contamination.
Type of operation and potential risk that can be in the plant are the two determining factors that can control the degree of hygiene in the facility. Segregation of area according to the requirement of hygiene level will have restricted access with rules and procedure set for people who are allowed entry in different level of cleanliness. As each processing unit require different.
The degree of hygiene control in the facility depends on the type of the operation and the analysis of the potential risk. Based on the assessment, the facility is divided into areas with different allowable processing steps, different rules and/or procedures for persons who are allowed entry, and/or different levels of cleanliness. Generally, the more sensitive the product or the consumer, the more important it is to separate the facility into different hygiene areas. Each manufacturing operation requires an appropriate environmental cleanliness level in order to minimize risks of contamination. Buffer zones, sanitizing stations, physical (or other) barriers are often placed between the basic GMP areas to the high hygiene areas.
Hygienic Zoning: Objective
Major constrain in zoning is to identify and differentiate areas within a facility for product and process protection. But once correct zoning has been done it can benefit in various ways. Hygienic zoning helps in maintaining product quality in the main product flow. Apart from increasing the efficiency it also has advantage from safety prospective as zoning prevent contamination of the product with substances that would adversely affect the health of a consumer.
Prevention of micro-contamination of the environment, the equipment, raw & packaging materials, people and product. Prevention of foreign body contamination, whatever the size and nature, of the environment, the equipment, the raw & pack materials, people and the product. Prevention of cross-contamination between flows of people, waste and materials. Prevention of cross-contamination and cross contact between incompatible products or ingredients (e.g. allergens or micro-specification). Establishment of basic environmental conditions necessary to produce safe product.
Type of Hygienic Zoning
There are three hygienic zones namely basic (Zone B, Zone B0, Zone B1), medium (Zone M) and high (zone H).
- Basic zones:
Zone B: are area which require basic level of hygienic design requirements. It encompasses areas in which products are produced that are not susceptible to contamination or that are protected in their final packages
Zone B0: are outside the building area, within the perimeter of the site where the objective is to control or reduce hazards created by unauthorized personnel entry and hazards created by water, dirt, dust and presence of animals.
Zone B1: includes warehouses that store both raw materials and packed processed products, offices, workshops, power supply areas, canteens and redundant buildings/rooms. The objective is to control or reduce hazards created by birds and pests.
- Medium Hygiene Zone
Zone M: are area in which medium level of hygienic design requirements is sufficient. It includes process areas where products are produced that are susceptible to contamination, but where the consumer group is not especially sensitive and where no further microbial growth is possible in the product in the supply chain. In this area, product might be exposed to the environment, during sampling and during the opening of equipment to clear blockages. The objective is to control or reduce the creation of hazardous sources that can affect an associated area of higher zone classification. The protection of the interior of food processing equipment from contamination when exposed to the atmosphere.
- High Hygiene Zone
Zone H: are area where the highest level of hygiene is required. A “High Hygiene” room in food processing is the equivalent of a cleanroom, must be completely contained. Zone H is typical for open processing, where even short exposure of product to the atmosphere can result in a food safety hazard. Products and ingredients that are processed or stored and are destined for a highly susceptible consumer group (e.g., infant nutrition), are instant in nature or ready for consumption. The objective is to control all product contamination hazards and to protect the interior of food processing equipment from exposure to atmosphere. Filtered air must be supplied to this a
Zoning Risk Assessment: Zoning can be done only after correct assessment of risk. On the basis of risk, the areas can be segregated into different zones. For assessment, one has to look into each and every factors that can affect the quality of product in unwanted way. While risk assessment, a complete preventive approach should be considered against factors including microbiological, chemical, allergen, physical or pest infestation. Not only these but there are other factors as well which need to be combated with like allergens. Part from these factors area not coming under production area should also be taken into consideration such as maintenance areas and equipment storage area, both temporary and permanent.
Key Components of Zoning: Zoning plan consists of zoning map, local procedure including rules for each zone, identification of barriers both physical and virtual and verification plan. Zoning maps typically include indication of hygienic zone, people movement i.e., deciding the entry/exit points, material movement, waste movement i.e., its collection and exit points. Major factor being deciding barriers and transitions between zones to maintain hygiene.
Zones should be clearly identified through marking, signage or physical barriers at transitions and entry/exit points. Entry requirements to production areas and transitions between zones should be clearly defined for people and materials. Site zoning plan should be supported by a verification plan with activities defined as appropriate for the site. Negative trends should lead to a root cause analysis and corrective actions. Zoning plan should be communicated to all factory personnel. Staff should understand which routines apply to their job function and activities. Visitors, contractors, service providers, other 3rd parties should be informed of the zoning plan prior to entry
Ideally, a facility should be designed to provide a flow pattern for food products, personnel, and equipment to prevent contact of the finished product with raw materials. Flow should be in one direction and follow a logical sequence from raw material handling to finished product storage. And for waste it should be from most hygienic area to low hygiene area. Applying concept of hygiene zoning will ensure food safety in the manufacturing unit.