如何解决《药品生产质量管理规范》要求的A级洁净区1m^3采样问题  

Discussion on sampling method of 1m^3 for grade A area by Good manufacturing practice for medicinal products

作　　者：许钟麟[1] 张彦国[1] 张益昭[1] 曹国庆[1] 梁磊[1] 

机构地区：[1]中国建筑科学研究院

出　　处：《暖通空调》2016年第6期71-72,36,共3页Heating Ventilating & Air Conditioning

摘　　要：《药品生产质量管理规范》(GMP)要求A级洁净区采样量1 m^3来源于ISO标准(更早为209C)能测出20粒微粒的最小采样量要求,所需采样时间太长。根据GMP中关于检测方法参照ISO 14644-1的说明,认为可以用流量为28.3L/min的粒子计数器在每点只采样1次或采用顺序采样法测试,使采样时间最短可降到每点8min。The requirement,the total sample volume should not be less than 1 m3 for grade A area which is described in Good manufacturing practices for medicinal products,derives from the minimum sampling volume demand of twenty particulates required by ISO standard（the former edition is 209C）.According to the requirement,the corresponding sampling time is too long.On the basis of the explanation of GMP,which recommends the sampling method referring to ISO 14644-1,considers that a discrete airborne particle counter with 28.3 L/min sampling flow rate could be used for monitoring the concentration of particles only once at one sampling point in the grade A area,or using the sequential sampling procedure.Based on the sequential sampling method,the sampling time may be shortened to at least eight minutes for each sampling point.

关 键 词：GMP 采样量 A级洁净区 顺序采样法 采样时间 

分 类 号：TQ460.8[化学工程—制药化工] TU834.85[建筑科学—供热、供燃气、通风及空调工程]