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What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification?
Key changes impacting pharmaceutical cleanrooms include a number of factors including:
Application and uncertainty of ≥5.0µm particles in Grade A and Grade B environments for classification and monitoring to ISO 5
Removal of the 95% UCL calculations
Increase in sampling locations for most cleanrooms
ISO classification classes
The ISO 14644-1 changes impact the basis for classification moving from ‘classification by formula’ to ‘classification by table’ (with a formula for intermediate sizes). The changes have resulted from a re-evaluation of the sensitivity of airborne particle counters and the instrument’s capacity to count small concentrations. In the case of particles ≥0.5µm, the collection efficiency has been reconsidered.
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