无尘车间洁净等级标准
净化等级行业规范
净化等级行业规范
美国联邦标准(USA Federal Standard) 209E (1992年)
洁净度级别 Clean Class | 粒径 Particles Size (um) | ||||
0.1 | 0.2 | 0.3 | 0.5 | 5.0 | |
1 | 35.0 | 7.5 | 3.0 | 1 | --- |
10 | 350 | 75.0 | 30 | 10 | --- |
100 | --- | 750 | 300 | 100 | --- |
1000 | --- | --- | --- | 1000 | 7.0 |
10000 | --- | --- | --- | 10000 | 70.3 |
100000 | --- | --- | --- | 100000 | 700 |
单位:尘埃数量个/ft3
无尘车间净化等级标准ISO14644国际净化标准
ISO Classification Number (N) | 0.1um | 0.2um | 0.3um | 0.5um | 1.0um | 5.0um |
ISO Class 1 | 10 | 2 | --- | --- | --- | --- |
ISO Class 2 | 100 | 24 | 10 | 4 | --- | --- |
ISO Class 3 | 1000 | 237 | 102 | 35 | 8 | --- |
ISO Class 4 | 10000 | 2370 | 1020 | 352 | 83 | --- |
ISO Class 5 | 100000 | 23700 | 10200 | 3520 | 832 | 29 |
ISO Class 6 | 1000000 | 237000 | 102000 | 35200 | 8320 | 293 |
ISO Class 7 | --- | --- | --- | 352000 | 83200 | 2930 |
ISO Class 8 | --- | --- | --- | 3520000 | 832000 | 29300 |
ISO Class 9 | --- | --- | --- | 35200000 | 8320000 | 293000 |
单位:PC/M3
净化等级标准之中国药品生产洁净室(区)空气洁净度标准
洁净度级别 Clean Class | 尘埃*大允许数/立方米 Maximum pemit quantity of Particles percubic metre | 尘埃*大允许数/立方米 Maximum pemit quantity of Microorganism | ||
≥0.5um | ≥5.0um | 浮游菌个/M3 | 浮游菌个/·30min | |
100 | 3,500 | 0 | 5 | 1 |
1000 | 35,000 | 2,000 | 100 | 3 |
10000 | 350,000 | 20,000 | 500 | 10 |
100000 | 3,500,000 | 61,800 | --- | 15 |
国家药品监督管理局1999年8月1日发布实施
苏州世煦机电设备有限公司是净化风机、净化设备(FFU,初中高效空气过滤器,滤网,风淋室,货淋室,风淋通道,洁净门,FFU风机过滤机组, FFU网络集中控制器,层流罩,净化无尘无菌工作台,无尘衣柜,无尘置物柜,净化洁净棚,无尘车间,传递窗,称量室,风淋传递窗,自净器,洁净采样车,生物**柜,净化洗手机,高效送风口)及洁净室净化工程设计施工维护为一体的净化企业。