FDA Air Classificationsa
ISO Class Designation | Clean Area Classification | ≥0.5 μm Particles/m3 | Microbiological Active Air Action Levelsb (cfu/m3) |
---|---|---|---|
5 | 100 | 3520 | 1c |
6 | 1000 | 35,200 | 7 |
7 | 10,000 | 352,000 | 10 |
8 | 100,000 | 3,520,000 | 100 |
↵a All classifications based on data measured in the vicinity of exposed materials/articles during periods of activity.
↵b Values represent recommended levels of environmental quality. You may find it appropriate to establish alternate microbiological action levels due to the nature of the operation or method of analysis.
↵c Samples from Class 100 (ISO Class 5) environments should normally yield no microbiological contaminants.