General Cleanroom Information
What is a cleanroom?
The most accurate way of answering this question is by quoting the ISO standard definition of a cleanroom. This is the standard which all cleanrooms must conform to and the following explanation gives the defining parameters of a cleanroom -
"Cleanroom - Room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room........"
Ref: International standard ISO14644-1 first edition 1999-05-01
Cleanroom Classification Table
| Cleanroom Standard |
Cleanroom Classification Guidelines |
| ISO 14644-1 |
Class 3 |
Class 4 |
Class 5 |
Class 6 |
Class 7 |
Class 8 |
| Federal Standard 209E |
1 |
10 |
100 |
1,000 |
10,000 |
100,000 |
| EU GGMP |
- |
- |
A/B |
- |
C |
D |
| Air changes / hour |
360-540 |
300-540 |
240-480 |
150-240 |
60-90 |
5-48 |
Selected Airborne Particulate Cleanliness Classes
For cleanrooms and clean zones shown in ISO 14644-1:1999
| ISO Classification Number |
Maximum concentration limits (particles/m³ of air) for particles equal to and larger than the considered sizes shown below |
|
≥0.1µm |
≥0.2µm |
≥0.3µm |
≥0.5µm |
≥1µm |
≥5.0µm |
| ISO Class 1 |
10 |
2 |
- |
- |
- |
- |
| ISO Class 2 |
100 |
24 |
10 |
4 |
- |
- |
| ISO Class 3 |
1,000 |
237 |
102 |
35 |
8 |
- |
| ISO Class 4 |
10,000 |
2,370 |
1,020 |
352 |
83 |
- |
| ISO Class 5 |
100,000 |
23,700 |
10,200 |
3,520 |
832 |
29 |
| ISO Class 6 |
1,000,000 |
237,000 |
102,000 |
35,200 |
8,320 |
293 |
| ISO Class 7 |
- |
- |
- |
352,000 |
83,200 |
2,930 |
| ISO Class 8 |
- |
- |
- |
3,520,000 |
832,000 |
29,300 |
| ISO Class 9 |
- |
- |
- |
35,200,000 |
8,320,000 |
293,000 |
Cleanroom Limits for Airborne Particulate Contamination
Relating to GGMP
| Cleanroom Standard |
Maximum permitted number of particles /m³ |
| EU GGMP Grade |
ISO EN 14644-1 |
At rest ≥0.5µm |
At rest ≥5.0µm |
In operation ≥0.5µm |
In operation ≥5.0µm |
| A |
5 |
3,520 |
20 |
3,520 |
20 |
| B |
5 |
3,520 |
29 |
352,000 |
2,900 |
| C |
7 |
352,000 |
2,900 |
3,520,000 |
29,000 |
| D |
8 |
3,520,000 |
29,000 |
Not defined |
Not defined |
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