Cleanliness Classification
1963, in the FED STANDARD 209, clean room classified some class as per the maximum limited of dust in the unit cubic inch space≥0.5μm, for example, class 100, class 10000, class 100000. Chinese clean room is also in accordance with this kind of standard for classification.
1999, ISO published ISO14644-1”CLEAN ROOM AND BE CONTROLLED CLEAN ENVIRONMENT, 1ST PART: AIR CLEANLINESS CLASSIFICATION”, ISO specified the cleanliness class and the traditional classification as per the below form:
| ISO14644 class | Max Concentration limit（particle qty/m3） | Approximate Corresponding Traditional Standard | |||||
| 0.1μm | 0.2μm | 0.3μm | 0.5μm | 1.0μm | 5.0μm | ||
| ISO 1 class | 10 | 2 |
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| ISO 2 class | 100 | 24 | 10 | 4 |
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| ISO 3 class | 1,000 | 237 | 102 | 35 | 8 |
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1 class |
| ISO 4 class | 10,000 | 2,370 | 1,020 | 352 | 83 |
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10 class |
| ISO 5 class | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | 100 class |
| ISO 6 class | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | 1,000 class |
| ISO 7 class |
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352,000 | 83,200 | 2,930 | 10,000 class |
| ISO 8 class |
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3,520,000 | 832,000 | 29,300 | 100,000 class |
| ISO 9 class |
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35,200,000 | 8,320,000 | 293,000 |
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Formulization the above value：
Cn = 10N × (0.1/D)2.08
Cn — Max allowable > a certain grain size PM’s qty concentration/m³;
N — ISO cleanliness class;
D — PM Dimension，Unit: micrometer;
0.1 — Constant，Unit: micrometer.
PS: GMP specified the cleanliness
| Cleanliness Class | Max qty of PM | Max sty of microorganism | Be equal to ISO classification | ||
| ≥0.5μm | 5μm | Floating bacteria/m3 | Sediment bacteria/vessel | ||
| 100 class | 3,500 | 0 | 5 | 1 | ISO 5 class |
| 10,000 class | 350,000 | 2,000 | 100 | 3 | ISO 7class |
| 100,000 class | 3,500,000 | 20,000 | 500 | 10 | ISO 8 class |
| 300,000 class | 10,000,000 | 60,000 |
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15 |
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