Classification of air quality for manufacture of sterile products
Clean room classes |
A |
B |
C |
D |
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Comparable clean room class according to... |
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US Fed. Std.209 |
100 |
100 |
10,000 |
100,000 |
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VDI 2083 |
3 |
3 |
5 |
6 |
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Type of air flow |
Laminar flow in the working area |
Non-laminar flow |
Non-laminar flow |
Non-laminar flow |
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Air change |
1/h |
360－540 |
＞20 |
＞20 |
＞20 |
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Average air velocity |
m/s |
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vertically |
0.3 |
－ |
－ |
－ |
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horizontally |
0.45 |
－ |
－ |
－ |
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Maximum permitted number of viable microorganisms |
1/m3 |
＜1* |
max. 5* |
max. 100 |
max. 500 |
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Maximum permitted number of particles |
1/m3 |
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≧0.5 mm |
3,500 |
3,500 |
350,000 |
3,500,000 |
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≧5 mm |
none |
none |
2,000 |
20,000 |
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※The marked low values can be reliably determined only by a great number of air samples.