Table 3.
Airborne particulate classification for these grades, according to the PIC/S GMP and EU-GMP.
| Grade | Maximum number of particles permitted/m3 | |||
|---|---|---|---|---|
| At rest | In operation | |||
| ≥0.5 µm | ≥5.0 µm | ≥0.5 µm | ≥5.0 µm | |
| Aa | 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 |
aAll areas must be free particles of size greater than 5 μm. Limits are set to 1 particle/m3 because it is impossible to ensure the absence of particles with any statistical significance. The periodic classification of facilities (cleanroom) must show that all areas meet the defined limits.