The pharmaceutical industry defines its own GMP classes A, B, C and D, which are based on the ISO standards in terms of particle concentration, but also specify limit values for harmful microorganisms.
In order to operate a Cleanroom, particle measurements must be carried out during acceptance and during operation. These measurements are used to classify the cleanliness of the room. The classification into cleanroom classes describes the exposure of the room atmosphere to particles of different sizes per room volume.
Briefly explained: Cleanroom classes
The DIN EN ISO 141644-1 standard, which classifies air cleanliness into cleanroom classes from 1-9 depending on the number of particles/m³, has become established worldwide as a uniform standard.
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