What do the ISO 14644-1 changes mean for pharmaceutical cleanroom classification?

FAQs Standards

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.