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standards in various countries of Clean room

2014-05-20 12:32:17

Cleanroom standards in various countries

美国联邦标准(USAFederalStandard209E1992年)

洁净度级别

Clean class level

粒径(um)

Particle size

 

0.1

0.2

0.3

0.5

5

1

35

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

70.3

100000

NA

NA

NA

100000

700

单位:尘埃数量个/ft3

中国药品生产洁净室(区)的空气洁净度标准

Chinese pharmaceutical manufacturing clean room ( area ) of the air cleanliness standards

 

洁净度级别

尘埃最允许数/平方米

微生物最大允许数

 

≥0.5um

≥5um

浮游菌个/立方米

沉降菌个/.30min

100

3500

0

5

1

10000

350,000

2,000

100

3

100000

3,500,000

20,000

500

10

300000

10,500,000

61,800

NA

15

国家药品监督管理局199981发布实施

基于≥0.5um粒径的各国洁净度等级近似对照表

■ Based on ≥ 0.5um particle size approximate national level of cleanliness table

/M3≥0.5um

ISO
14644-
1(1999)

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