CLEANROOM CLASSIFICATION
A cleanroom is classified according to the number and the size of airborne particles permitted per volume of air. For companies which have to comply with cleanroom standards, cleanrooms must be designed, installed and operated correspondingly to different classification methods, depending on the environment where they are utilized.
International Standards Organization or ISO issued the following documents to help classify cleanrooms:
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ISO 14644-1 Standard |
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Class |
Maximum particles/ m 3 |
FED STD 209E equivalent |
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≥0,1μm |
≥0.2μm |
≥0.3μm |
≥0,5μm |
≥1μm |
≥5μm |
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ISO 1 |
10 |
2,37 |
1,02 |
0,35 |
0,083 |
0.0029 |
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ISO 2 |
100 |
23,7 |
10,2 |
3,5 |
0,83 |
0,029 |
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ISO 3 |
1.000 |
237 |
102 |
35 |
8,3 |
0,029 |
Class 1 |
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ISO 4 |
10.000 |
2.370 |
1.020 |
352 |
83 |
2,9 |
Class 10 |
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ISO 5 |
100.000 |
23.700 |
10.200 |
3.520 |
832 |
29 |
Class 100 |
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ISO 6 |
1,0 x 10 6 |
237.000 |
102.000 |
35.200 |
8.320 |
293 |
Class 1.000 |
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ISO 7 |
1,0 x 10 7 |
2,37 x 10 6 |
1.020.000 |
352.000 |
83.200 |
2.930 |
Class 10.000 |
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ISO 8 |
1,0 x 10 8 |
2,37 x 10 7 |
1,02 x 10 7 |
3.520.000 |
832.000 |
29.300 |
Class 100.000 |
|
ISO 9 |
1,0 x 10 9 |
2,37 x 10 8 |
1,02 x 10 8 |
35.200.000 |
8.320.000 |
293.000 |
Room Air |
US Federal Standards 209E is now superseded:
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US Federal Standards 209E for Cleanroom standards |
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Class |
Maximum particles/ ft 3 |
ISO 14644-1 equivalent |
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≥0,1μm |
≥0.2μm |
≥0.3μm |
≥0,5μm |
≥5μm |
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|
1 |
35 |
7,5 |
3 |
1 |
0,007 |
ISO 3 |
|
10 |
350 |
75 |
30 |
10 |
0,07 |
ISO 4 |
|
100 |
3.500 |
750 |
300 |
100 |
0,7 |
ISO 5 |
|
1.000 |
35.000 |
7.500 |
3.000 |
1.000 |
7 |
ISO 6 |
|
10.000 |
350.000 |
75.000 |
30.000 |
10.000 |
70 |
ISO 7 |
|
100.000 |
3,5 x 10 6 |
750.000 |
300.000 |
100.000 |
700 |
ISO 8 |
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US FED STD 209E was officially cancelled by General Services Administration on November 29th 201 but it is still widely used. |
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British Standard 5295 cleanroom standards:
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BS 5295 cleanroom standards |
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Class |
≥0,5μm |
≥1μm |
≥5μm |
≥10μm |
≥ 25μm |
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Class 1 |
3.000 |
0 |
0 |
0 |
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Class 2 |
300.000 |
2.000 |
30 |
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Class 3 |
1.000.000 |
20.000 |
4.000 |
300 |
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Class 4 |
200.000 |
40.000 |
4.000 |
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BS 5295 Class 1 also requires that the greatest particle present in any sample cannot exceed 5 um. |
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EU GMP Classification:
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EU GMP Classification |
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Class |
Maximum particles/ m 3 |
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At rest |
In operation |
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0.5μm |
5μm |
0.5μm |
5μm |
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Class A |
3.520 |
20 |
3.500 |
20 |
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Class B |
3.520 |
29 |
352.000 |
2.900 |
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Class C |
352.000 |
2.900 |
3.520.000 |
29.000 |
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Class D |
3.520.000 |
29.000 |
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351/53 Le Van Sy, Ward 13, District 3, Ho Chi Minh City. |
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Telephone: 0912 372 634/ 0987 974 150 |
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Email: congtywishine@gmail.com |