■ 美國聯邦標準（USA Federal Standard）209E（1992年）
| 潔凈度級別 |
粒 徑(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 |
■ 中國藥品生產潔凈室（區）的空氣潔凈度標準
| 潔凈度級別 |
塵埃最允許數/平方米 |
微生物最大允許數 |
|
≥0.5um |
≥5um |
浮游菌個/立方米 |
沉降菌個/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 |
■ 基于≥0.5um粒徑的各國潔凈度等級近似對照表
個/
M3≥0.5um |
ISO
14644-1
(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 |
- |
- |
- |
- |
- |
■ 潔凈室及潔凈區空氣中懸浮粒子潔凈度等級
空氣潔凈度等級(N) |
大于或等于表中粒徑的最大濃度限值(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 |
|
