|
|
|
>> |
洁净级别国际行业标准(一) |
|
|
|
■ 美国联邦标准（USA Federal Standard）
空气中微粒的洁净等级对照
空气微粒洁净等级 （每立方米，每立方英尺）微粒的最大浓度限值 ISO14644-1 | FED STD 209E | CLASS | Number of Par Cubic Meter by Micrometer Size | ISO Class | English | Metric | | 0.1um | 0.2um | 0.3um | 0.5um | 0.5um | 5um | | | | | m3 | m3 | m3 | ft3 | m3 | | 1 | | | ISO1 | 10 | 2 | | | | | 2 | | | ISO2 | 100 | 26 | 10 | | 4 | | 3 | 1 | M1.5 | 1SO3 | 1,000 | 265 | 106 | | 35 | | 4 | 10 | M2.5 | ISO4 | 10,000 | 2,650 | 1,060 | 10 | 353 | | 5(百级) | 100 | M3.5 | ISO5 | 100,000 | 26,500 | 10,600 | 100 | 3,530 | 29 | 6(千级) | 1,000 | M4.5 | ISO6 | 1,000,000 | 265,000 | 106,000 | 1000 | 35,300 | 293 | 7(万级) | 10,000 | M5.5 | ISO7 | | | | 10000 | 353,000 | 2,930 | 8(十万级) | 100,000 | M6.5 | ISO8 | | | | 100000 | 3,530,000 | 29,300 | 9 | | | ISO9 | | | | 1000000 | 35,300,000 | 293,000 |
| |
■ 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/立方米 | 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
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 | - | - | - | - | - |
|
|
|
|
|
|
|
