1、1.00NA1035075.030.010.010075030010007.01000070.3100000700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 尘埃最允许数/平方米微生物最大允许数0.5um5um浮游菌个/立方米沉降菌个/皿.30min35005350,0002,00033,500,00020,00050030000010,500,00061,80015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/M30.5umISO14644-1(1999)US209E(1992)209D(1988)EECGGMP(1989
2、)FRANCEAFNOR(1981)GERMANYVDI 2083(1990)JAPANJAOA(1989)-3.52M135.3M1.5M23534M2.51,000M33,530M3.5A+B4,00010,000M435,3006M4.5100,000M5353,0007M5.5C400,0001,000,000M63,530,0008M6.5D4,000,00010,000,000M7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)0.1um0.2um0.3um0.5um1um5um24237102352370102035283237001020035208322910000002370001020003520083202933520008320029303520000832000293009352000008320000293000国家标准GB50073-2001