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Recommended limits for viable airborne particles on personnel according to FDA-cGMP, EU-GMP, and USP.
| Clean area type | Maximal number of cfu | ||||
|---|---|---|---|---|---|
| EU-cGMP | USP | ||||
| FS209E | ISO | EU GMP | Glove print (5 fingers) (cfu/glove) | cfu per contact plate | |
| Gloves | Personnel clothing and garb | ||||
| M3.5 (100) | 5 | A | <1 | 3 | 5 |
| M5.5 (10,000) | 7 | B | 5 | 10 | 20 |
