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Clean rooms and air quality

Filtration in clean rooms eliminates microorganisms

In clean rooms, this is achieved using HEPA filters, which are designed to remove up to 99.997% of particles from the air. HEPA filters are protected from clogging by pre-filters, which remove up to approximately 90% of particles from the air.

Therefore, if the air contains approximately 3 x 108 particles per m3 and there is a prefilter and a HEPA filter, the prefilter removes a sufficient number of particles to leave approximately 3 x 107 per m3 as a challenge for the HEPA filter.

The HEPA filter will leave around 103 per m3 to enter the clean room. In EU GMP, this relatively low number is within the limits for Grade A/ISO Class 5 and Grade B/ISO Class 7 “at rest” (Annex 1.4).

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