BPF 1989 – Pharmaceutical Industry Guide
Controlled Room Classification StandardsCONTROLLED ROOM CLASSIFICATION STANDARDS
BPF 1989 (Pharmaceutical Industry Guide)
CLEAN ROOMS
Classification of the different air qualities required to manufacture sterile products:
| Maximum Nº of particles per m3 of air, with a dimension equal or superior to | Max. Nº of microorganisms per m3 of air (in activity) | ||||
|---|---|---|---|---|---|
| 0.5 µm | 5 µm | 0.5 µm | 5 µm | ||
| In non-activity (b) | In activity | ||||
| A | 3500 | 0 | 3500 | 0 | <1 |
| B | 3500 | 0 | 350000 | 2000 | 10 |
| C | 350000 | 2000 | 3500000 | 20000 | 100 |
| D | 3500000 | 20000 | not defined (c) | not defined (c) | 200 |
