Clean-room conditions validation

Classification and monitoring to the Clean Room Standards requires that particular numbers of samples of air be taken per unit floor area, that samples be taken in specified locations, and that samples be taken at appropriate frequencies. Table 2 summarizes these requirements. It is evident that the evolution of the US standard from FS 209B to FS 2WE. both for validation and for routine monitoring, is toward the as otherwise specific" condition, which bounces the onus for decision-making back to the user and his customer. This is not the case for the British Standard. To validate a clean room, the British Standard BS 5295.1989 asks for more locations and more replicate testing at each location than BS 5295.1976 or either revision of the U.S. standard.. 

Some medical device manufacturers are confused with the requirements for an equipment performance qualification (PQ). In general, a PQ is not required for manufacturing equipment if its performance is demonstrated during process validation (PV) where the equipment must be shown to perform under the unique conditions of every product (or range of products). A separate equipment PQ is only required when it is used in a manufacturing support role, which typically includes compressed air systems, clean rooms, and purified water systems. 

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