CLEANROOM SPECIFICATIONS
CLEANROOM SPECIFICATIONS
CLEANROOM STANDARDS
ISO 14644-1 : 2015
table 1: selected airborne particulate cleanliness classes for cleanrooms and clean zones
| ISO Classification Number (N) |
Maximum concentration limits (particles / m3 of air) for particles equal to and larger than the considered sizes below |
FED STD 209ENearest equivalent Class |
BS5295 1989Nearest equivalent Class |
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| 0.1µm | 0.2µm | 0.3µm | 0.5µm | 1µm | 5µm | |||
| ISO Class 1 | 10 | 2 | ||||||
| ISO Class 2 | 100 | 24 | 10 | 4 | ||||
| ISO Class 3 | 1000 | 237 | 102 | 35 | 8 | 1 | C | |
| ISO Class 4 | 10000 | 2370 | 1020 | 352 | 83 | 10 | D | |
| ISO Class 5 | 100 000 | 23 700 | 10 200 | 3520 | 832 | 29 | 100 | E (F) |
| ISO Class 6 | 1 000 000 | 237 000 | 102 000 | 35 200 | 8320 | 293 | 1000 | H (G) |
| ISO Class 7 | 352 000 | 83 200 | 2930 | 10 000 | J | |||
| ISO Class 8 | 3 520 000 | 832 000 | 29 300 | 100 000 | K | |||
| ISO Class 9 | 35 200 000 | 8 320 000 | 293 000 | |||||
EU GMP ANNEX 1 : 2022
Maximum permitted total particle concentration for classification
Maximum permitted total particle concentration for classification
| Maxiumum limits for total particle ≥ 0.5 µm/m3 |
Maxiumum limits for total particle ≥ 0.5 µm/m3 |
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| Grade | at rest | in operation | at rest | in operation |
| A | 3 520 | 3 520 | Not specified | Not specified |
| B | 3 520 | 352 000 | Not specified | 2 930 |
| C | 352 000 | 3 520 000 | 2 930 | 29 300 |
| D | 3 520 000 | Not predetermined | 29 300 | Not predetermined |
Maximum permitted microbial contamination
| Grade | Air sample CFU/m3 | Settle Plates (diam.90mm) CFU/4 hours |
Contact plates (diam.55mm) CFU/plate |
| A | No growth | No growth | No growth |
| B | 10 | 5 | 5 |
| C | 100 | 50 | 25 |
| D | 200 | 100 | 50 |