Table 4 Overview of environmental monitoring after placing the automated dispensing system
Day 1 | Day 2 | Day 3 | Criteria GMP class A | |
|---|---|---|---|---|
Settle plates CFU/4 h average | 0.2 | 0 | 0 | < 1 CFU |
Contact plates CFU/plate average | 0 | 0 | 0 | < 1 CFU |
Particles at rest | 0.5 µm: 24.7/m3 5.0 µm: 0.0/m3 | 0.5 µm: 42.4/m3 5.0 µm: 0.0/m3 | 0.5 µm: 219.1/m3 5.0 µm: 7.1/m3 | 0.5 µm: ≤ 3520 /m3 5.0 µm: ≤ 20/m3 |
Particles in operation | 0.5 µm: 38.9/m3 5.0 µm: 0.0/m3 | 0.5 µm: 7.1/m3 5.0 µm: 0.0/m3 | 0.5 µm: 732.9/m3 5.0 µm: 12.0/m3 | 0.5 µm: ≤ 3520 /m3 5.0 µm: ≤ 20/m3 |
Bouillon simulation | Clear medium | Clear medium | Clear medium | Clear medium |