Table 7.
Recommended limits for viable airborne particles on surfaces according to EU-GMP and USP.
| Clean area type | Maximal number of cfu on surfaces | ||||
|---|---|---|---|---|---|
| EU GMP | USP | ||||
| FS209E | ISO | EU GMP | Contact plates (diam. 55 mm; cfu/plate) | Contact plates (area 24–30 cm2; cfu/plate)a | |
| Surfaces | Floor | ||||
| M3.5 (100) | 5 | A | <1 | 3 | 3 |
| M4.5 (1,000) | 6 | — | — | — | |
| M5.5 (10,000) | 7 | B | 5 | 5 | 10 |
| M6.5 (100,000) | 8 | C | 25 | — | — |
| D | 50 | — | — | ||
aContact plate areas vary from 24 to 30 cm2. When swabbing is used in sampling, the area covered should be greater than or equal to 24 cm2 but no larger than 30 cm2.