Table 6.
Recommended limits for viable airborne particles in the environment according to FDA-cGMP, EU-GMP, and USP.
| Clean area type | Maximal number of cfu in the environment | ||||||
|---|---|---|---|---|---|---|---|
| FDA-cGMP | EU-GMP | USP | |||||
| FS209E | ISO | EU-GMP | Air sample (cfu/m3) | Settle platesa (diam. 90 mm; cfu/4 h) | Air sample (cfu/m3) | Settle plates (diam. 90 mm; cfu/4 h)b | Air sample (cfu/m3) |
| M3.5 (100) | 5 | A | 1c | 1c | <1 | <1 | <3 |
| M4.5 (1,000) | 6 | 7 | 3 | — | — | ||
| M5.5 (10,000) | 7 | B | 10 | 5 | 10 | 5 | <20 |
| M6.5 (100,000) | 8 | C | 100 | 50 | 100 | 50 | <100 |
| D | — | — | 200 | 100 | — | ||
aThe additional use of settling plates is optional.
bIndividual settle plates may be exposed for less than 4 hours.
cSamples from class 100 (ISO 5) environments should normally yield no microbiological contaminants.