Pharmaceutical Area classification with respect to filters used as per WHO guidelines
WHO gmp guidelines describes area in a pharmaceutical Manufacturing facility, as Level 1 level 2 and level 3 areas.
Level 1 Area is place where there is no possibility of contamination of product, the product comes here after final packing if at all, this area is a general area which may be used for housekeeping and maintainace. (Non classified area)
Level 2 Area is area where the raw and packing material is stored in closed condition, this area is controlled with respect to temperature and humidity. These areas are not provided with coarse filters, the working benches and dispensing places may be provided with UDF units. (UDF unit is a unit having vertical laminar air flow) (Classified area)
Level 3. Is area where actually pharmaceutical ingredients raw material or under process product is exposed to environment, therefore this area is required to control for its quality of air and cleanness. This area is called as controlled area; these areas are supplied air filtered through HEPA filters. (Classified area)
Which Filters can be used as per WHO GMP guidelines for Level 1 level 2 and level 3 areas
Level 1: EN 779 G4 filters Primary filters only
Level 2: EN 779 G4 plus F8 or F9 filters air used in this area is 100 % outside air being filtered and supplied.
Level 3: EN 779 G4 plus F8 plus EN 1822 H13 filters. Recirculated air is used, where there is possibility of cross contamination hence three level filters are used as primary, secondary and tertiary filters.
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[…] PAL and Material Air Lock. Air locks are provided with HEPA filtered air supply with pressure to prevent the cross contamination. Clean up time: Clean up time is the time period required in a clean room at when a AHU is started air in the room starts getting filtered, and replaced with HEPA filtered air so that the particle count in the clean room comes to the rated count of the classification. For an example, a class 10000 area is at rest in morning and before AHU is started its count will be higher than the rated value, after AHU is started air in the clean room starts getting filtered through HEPA filter the particles get filtered and part of air is exhausted and part of fresh air is filtered and supplied so that the particle count in the room drops and is maintained to the level of acceptance as per rated class of the clean room, time period required to attain this is called as Clean up time. While describing the class of filter one must not use term as 3-micron filter or 5 micron or 10-micron filter As per WHO Guidelines On HVAC system, it may lead to wrong filter getting installed. Therefore, Filters nomenclature should be adapted as EN 779 and EN 1822 […]