|
|
■ 美国联邦标准（USA Federal Standard）209E（1992年）无尘室洁净度参照标准
|
洁净度级别
|
粒 径 (um)
|
|
|
0.1
|
0.2
|
0.3
|
0.5
|
5.0
|
|
1
|
35.0
|
7.50
|
3.00
|
1.00
|
NA
|
|
10
|
350
|
75.0
|
30.0
|
10.0
|
NA
|
|
100
|
NA
|
750
|
300
|
100
|
NA
|
|
1000
|
NA
|
NA
|
NA
|
1000
|
7.0
|
|
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
|
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/皿.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1999年8月1日发布实施
|
|
■ 基于≥0.5um粒径的各国洁净度等级近似对照表
|
个/M3≥0.5um
|
ISO
14644-1(1999)
|
US
209E(1992)
|
US
209D(1988)
|
EEC
GGMP(1989)
|
FRANCE
AFNOR(1981)
|
GERMANY
VDI2083(1990)
|
JAPAN
JAOA(1989)
|
|
1
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|
3.5
|
2
|
-
|
-
|
-
|
-
|
0
|
2
|
|
10.0
|
-
|
M1
|
-
|
-
|
-
|
-
|
-
|
|
35.3
|
3
|
M1.5
|
1
|
-
|
-
|
1
|
3
|
|
100
|
-
|
M2
|
-
|
-
|
-
|
-
|
-
|
|
353
|
4
|
M2.5
|
10
|
-
|
-
|
2
|
4
|
|
1,000
|
-
|
M3
|
-
|
-
|
-
|
-
|
-
|
|
3,530
|
5
|
M3.5
|
100
|
A+B
|
4,000
|
3
|
5
|
|
10,000
|
-
|
M4
|
-
|
-
|
-
|
-
|
-
|
|
35,300
|
6
|
M4.5
|
1,000
|
1,000
|
-
|
4
|
6
|
|
100,000
|
-
|
M5
|
-
|
-
|
-
|
-
|
-
|
|
353,000
|
7
|
M5.5
|
10,000
|
C
|
400,000
|
5
|
7
|
|
1,000,000
|
-
|
M6
|
-
|
-
|
-
|
-
|
-
|
|
3,530,000
|
8
|
M6.5
|
100,000
|
D
|
4,000,000
|
6
|
8
|
|
10,000,000
|
-
|
M7
|
-
|
-
|
-
|
-
|
- |
|
|
■ 洁净室及洁净区空气中悬浮粒子洁净度等级
|
空气洁净度等级(N)
|
大于或等于表中粒径的最大浓度限值(pc/m3)
|
|
|
0.1um
|
0.2um
|
0.3um
|
0.5um
|
1um
|
5um
|
|
1
|
10
|
2
|
|
|
|
|
|
2
|
100
|
24
|
10
|
4
|
|
|
|
3
|
1000
|
237
|
102
|
35
|
8
|
|
|
4
|
10000
|
2370
|
1020
|
352
|
83
|
|
|
5
|
100000
|
23700
|
10200
|
3520
|
832
|
29
|
|
6
|
1000000
|
237000
|
102000
|
35200
|
8320
|
293
|
|
7
|
|
|
|
352000
|
83200
|
2930
|
|
8
|
|
|
|
3520000
|
832000
|
29300
|
|
9
|
|
|
|
35200000
|
8320000
|
293000 | |
|
