Cleanroom Classifications
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| ISO Class 5 (Class A/B, US-Class 100) |
Sterile preparation - aseptic production, media fill and transfer |
| ISO Class 6 (US-Class 1 000) |
Sterile preparation - aseptic production; background of class A |
| ISO Class 7 (Class C, US-Class 10 000) |
Preparation of media before filtration; media fill before endsterilsation |
| ISO Class 8 (Class D, US-Class 100 000) |
Preparation of products before endsterilsation; handling of ingredients after cleaning process; background of isolators |
| Number of Particles per Cubic Meter | ||||||
|---|---|---|---|---|---|---|
| Class | 0.1micro m | 0.2micro m | 0.3micro m | 0.5micro m | 1micro m | 5micro m |
| ISO 1 | 10 | 2 | ||||
| ISO 2 | 100 | 24 | 10 | 4 | ||
| ISO 3 | 1 000 | 237 | 102 | 35 | 8 | |
| ISO 4 | 10 000 | 2 370 | 1 020 | 352 | 83 | |
| ISO 5 | 100 000 | 23 700 | 10 200 | 3 520 | 832 | 29 |
| ISO 6 | 1 000 000 | 237 000 | 102 000 | 35 200 | 8 320 | 293 |
| ISO 7 | 352 000 | 83 200 | 2 930 | |||
| ISO 8 | 3 520 000 | 832 000 | 29 300 | |||
| ISO 9 | 35 200 000 | 8 320 000 | 293 000 | |||
| Class 5 is expected to be free of particles >5micro m acc. Annex 1 point 3 more strict than ISO 14644 | ||||||
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