Classification guidelines for cleanrooms
Do you want a clear overview of which level of compliance your cleanroom environment demands according to the GMP Annex 1 and ISO standards? We have compiled all relevant guidelines here.
MAXIMUM ACTIONS LIMITS FOR MICROBIAL CONTAMINATION
| GMP Grade | Air Sample CFU/m³ | Settle plates (Ø 90mm) CFU/4 hours | Contact plates (Ø 55 mm) CFU/plate | Glove print 5 fingers, both hands CFU/glove |
| A | No growth | |||
| B | 10 | 5 | 5 | 5 |
| C | 100 | 50 | 25 | – |
| D | 200 | 100 | 50 | – |
SCHEDULE OF TESTING TO DEMONSTRATE COMPLIANCE FOR ALL ISO CLASSES
| Test parameter | Max. time interval | Classification | Test method |
| Particle count test | 6 months | ≤ ISO Class 5 | ISO 14644-1 |
| Particle count test | 12 months | > ISO Class 5 | ISO 14644-1 |
| Airflow volume or velocity | 12 months | All classes | ISO 14644-3 |
| Air pressure difference | 12 months | All classes | ISO 14644-3 |
| Airflow visualization | 24 months | All classes | ISO 14644-3 |
| Recovery test | 24 months | All classes | ISO 14644-3 |
SCHEDULE OF TESTING TO DEMONSTRATE COMPLIANCE FOR ALL GRADES ACCORDING TO GMP ANNEX 1
| GMP Grade | A | B | C | D |
| Suggested time interval for requalification of cleanroom* | 6 months | 6 months | 12 months | 12 months |
* The frequency must be justified based on risk with the CCS (contamination control strategy)
DIFFERENT CLEANROOM CLASSES ACCORDING TO ISO 14644 AND FED STD 209E
| ISO Class | FED STD 209E equivalent | Maximum particles/m³ (at rest and in operation) | |||||
| ≥ 0.1µm | ≥ 0.2µm | ≥ 0.3µm | ≥ 0.5µm | ≥ 1µm | ≥ 5µm | ||
| ISO 1 | 10 | ||||||
| ISO 2 | 100 | 24 | 10 | ||||
| ISO 3 | Class 1 | 1.000 | 237 | 102 | 35 | ||
| ISO 4 | Class 10 | 10.000 | 2.370 | 1.020 | 352 | 83 | |
| ISO 5 | Class 100 | 100.000 | 23.700 | 10.200 | 3.520 | 832 | |
| ISO 6 | Class 1.000 | 1.000.000 | 237.000 | 102.000 | 35.200 | 8.320 | 293 |
| ISO 7 | Class 10.000 | 352.000 | 83.200 | 2.930 | |||
| ISO 8 | Class 100.000 | 3.520.000 | 832.000 | 29.300 | |||
| ISO 9 | Room air | 35.200.000 | 8.320.000 | 293.000 | |||
MAXIMUM PERMITTED TOTAL PARTICLE CONCENTRATION FOR CLASSIFICATION ACCORDING TO GMP ANNEX 1
| GMP Annex 1 | Maximum particles/m³ | |||
| At rest | In operation | |||
| ≥ 0.5µm | ≥ 5µm | ≥ 0.5µm | ≥ 5µm | |
| GMP Grade A | 3.520 | Not specified (a) | 3.520 | Not specified (a) |
| GMP Grade B | 3.520 | Not specified (a) | 352.000 | 2.930 |
| GMP Grade C | 352.000 | Not specified (a) | 3.520.000 | 29.300 |
| GMP Grade D | 3.520.000 | 29.300 | Not pre-determined (b) | Not pre-determined (b) |
NOTE GMP ANNEX 1
(a) Classification including 5 µm particles may be considered where indicated by the contamination control strategy (CCS) or historical trends.
(b) For grade D, in operation limits are not predetermined. The manufacturer should establish in operation limits based on a risk assessment and routine data where applicable.
CONTACT US FOR MORE INFORMATION
Do you have a challenge in achieving compliance for your cleanrooms, isolators, LAF cabinets, BSCs or other controlled environments? Or are you struggling with planning, documentation or a technical interpretation? Do not hesitate to contact us. Our experts are happy to think along with you.
