Review Article
Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects
Table 8
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 |
|
|
