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|
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| 美国联邦标准（USA FEDERAL STANDARD）FS209E |
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洁净度级别
CLEAN CLASS
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粒 径 PARTICLE SIZE（um）
|
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0.1
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0.2
|
0.3
|
0.5
|
5.0
|
|
1
|
3.5
|
7.5
|
3
|
1
|
NA
|
|
10
|
350
|
75
|
30
|
10
|
NA
|
|
100
|
NA
|
750
|
300
|
100
|
NA
|
|
1000
|
NA
|
NA
|
NA
|
1000
|
7
|
|
10000
|
NA
|
NA
|
NA
|
10000
|
70
|
|
100000
|
NA
|
NA
|
NA
|
100000
|
700
|
|
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| 中国药品生产洁净室（区）的空气洁净度标准 |
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|
洁净度级别
CLEAN CLASS
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尘粒最大允许数/立方米
Maximum permit quantity of particles per cubic
metre
|
微生物最大允许数
Maximum permit quantity of microorganism
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|
≥0.5um
|
≥5um
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浮游菌/立方米 Quantity
of suspended bacteria per cubic metre
|
沉降菌/皿
Quantity of droped bacteria per
plate
|
|
100
|
3,500
|
0
|
5
|
1
|
|
10,000
|
350,000
|
2,000
|
100
|
3
|
|
100,000
|
3,500,000
|
20,000
|
500
|
10
|
|
300,000
|
10,500,000
|
60,000
|
NA
|
15
|
|
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|
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