■美国联邦标准（USA Federal Standard）209E（1992年）
| 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 |
■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 |
ISO14644-1(1999) |
US 209E (1992) |
US 209D (1988) |
EEC GGMP (1989) |
FRANCE AFNOR(1981) |
GERMANY VDI 2083(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 |
- |
- |
- |
- |
- |
■基于≥0.5um粒径的各国洁净度等级近似对照表
| 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 |
|
