Cleanroom standards tables: ISO 14644-1 and GMP Grades A–D
ISO 14644-1 classifies cleanrooms by the maximum number of particles per cubic metre. PIC/S GMP Annex 1 uses Grades A–D for sterile medicinal product manufacture. This page brings the most-used tables together in one place.
ISO 14644-1:2015 particle limits ≥ 0.5 µm
ISO 5
3,520
ISO 6
35,200
ISO 7
352,000
ISO 8
3,520,000
ISO 9
35,200,000
Source: ISO 14644-1:2015 Table 1, particles per cubic metre · ISO Class 9 applies to the operational state only
GMP Grades under PIC/S GMP Annex 1 (PE 009-17), particles/m³
| Grade | ≥ 0.5 µm | ≥ 5 µm | ||
|---|---|---|---|---|
| At rest | In operation | At rest | In operation | |
| A | 3,520 (≈ ISO 5) | 3,520 (≈ ISO 5) | Not specified* | Not specified* |
| B | 3,520 (≈ ISO 5) | 352,000 (≈ ISO 7) | Not specified* | 2,930 |
| C | 352,000 (≈ ISO 7) | 3,520,000 (≈ ISO 8) | 2,930 | 29,300 |
| D | 3,520,000 (≈ ISO 8) | Not predetermined (set by manufacturer) | 29,300 | Not predetermined (set by manufacturer) |
Source: PIC/S PE 009-17 Annex 1 Table 1 (classification) · * 5 µm classification may be considered where indicated by the CCS or historical trends · In Thailand, the MOPH GMP notification B.E. 2569 allows Annex 1 to follow PE 009-16 until 31 December 2029; the ≥ 0.5 µm limits are the same, but the ≥ 5 µm limits differ. See the comparison table
Minimum number of sampling locations (ISO 14644-1:2015 Table A.1)
2
1
10
5
24
6
52
10
104
16
232
22
1,000
27
Source: ISO 14644-1:2015 Table A.1 (room area in m² → minimum number of locations). For rooms larger than 1,000 m², use Formula A.1 in the standard
Retest intervals
ISO 14644-2:2015 (particle classification)
12 months
PIC/S GMP Annex 1: Grade A, B
6 months
PIC/S GMP Annex 1: Grade C, D
12 months
Source: ISO 14644-2:2015 · PIC/S PE 009-17 Annex 1 clause 4.32 (maximum intervals) · Requalification is also required after remedial action or significant change
