| Air Filtration to Control Contamination | |||||||
| ISO 14644-1 Class | Recommended filtration | ||||||
| ISO Class 9 | Equivalent to level 1 or Pharmaceutical condition: G4 filters | ||||||
| ISO Class 8 | Production facility operating on 100% outside air: G4 and F8 filters | ||||||
| ISO Class 8 | Production facility operating on recirculated plus ambient air: where potential for product cross-contamination exists. G4,F8 &H13 filters | ||||||
| ISO Class 7 | Facility operating on recirculated air or 100% ambient air:G4,F8 & H13 filters(HEPA filters may be located terminally or in AHU) | ||||||
| ISO Class 6 | Facility operating on recirculated air or 100% ambient air:G4,F8 & H13 filters(HEPA filters to be terminally located.) | ||||||
| ISO Class 5 | Facility operating on recirculated air or 100% ambient air:G4,F8 & H13 filters(HEPA filters to be terminally located.) | ||||||
| The filter classifications referred to above relate to the EN1822 and EN779 test standards | |||||||
| which are the latest filter test standards, recommended for international use. (EN 779 relates | |||||||
| to filter classes G1 to F9 and EN 1822 relates to filter classes H10 to U16.) | |||||||
| ISO Class 1 | |||
| ISO Class 2 | |||
| ISO Class 3 | M1 & M1.5 | 1 | |
| ISO Class 4 | M2 & M2.5 | 10 | |
| ISO Class 5(L) | M3 & M3.5 | 100 (L) | Class A |
| ISO Class 5(T) | M3.5 | 100(T) | Class A |
| ISO Class 6 | M4.5 & M5 | 1000 | Class B |
| ISO Class 7 | M5 & M5.5 | 10 000 | Class C |
| ISO Class 8 | M6 & M6.5 | 100 000 | Class D |
| ISO Class 9 | M7 | 1,000,000 | Class E |
