Our cleanrooms for sterile manufacturing of MSC cellular products are built accordingly to meet current Good Manufacturing Practices (cGMP) of the Pharmaceutical Inspection Co-operation Scheme, ISO cleanroom guidelines and World Health Organization guidelines on GMP.
Cleanliness Level
|
Grade | Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes shown | |||
| At rest | In operation | ||||
| ≥0.5 µm | ≥5.0 µm | ≥0.5 µm | ≥5.0 µm | ||
Extremely clean
Clean | A | 3,520 | 20 | 3,520 | 20 |
| B | 3,520 | 29 | 352,000 | 2,900 | |
| C | 352,000 | 2,900 | 3,520,000 | 29,000 | |
| D | 3,520,000 | 29,000 | Not defined | Not defined | |