摘要
目的:分析不同检测方法异同及其合理性有效性。方法:采用现行GB/T 16292-2010医药工业洁净室(区)悬浮粒子的测试方法和ISO 14644-1:2015洁净室和相关受控环境分别对同一洁净区进行悬浮粒子监测,针对得到的检验数据进行分析。结果:洁净实验室采样点数目不超过9个点的时候,使用ISO14644-1:2015对洁净实验区域监测操作性更强,采样数据处理简单方便,结果判断简便,异常情况处理程序明显减少。结论:ISO 14644-1:2015与GB/T 16292-2010相比更为科学,采样点数量的确定方法更具有统计学意义。
Objective:To analyze the similarities and differences of different detection methods and their rationality and effectiveness.Methods:The current GB/T 16292-2010 pharmaceutical industry clean room(area)suspended particle test method and ISO 14644-1:2015 clean room and related controlled environment were used to monitor suspended particles in the same clean area,and the test data were analyzed.Results:When the number of sampling points in the clean operating laboratory was not more than 9,the monitoring operability of ISO14644-1:2015 was stronger,the sampling data processing was simple and convenient,the result judgment was simple,and the abnormal situation processing procedures were significantly reduced.Conclusion:ISO 14644-1:2015 is more scientific than GB/T 16292-2010,and the method to determine the number of sampling points is more statistically significant.
作者
陈明桥
林铁豪
欧国栋
CHEN Mingqiao;LIN Tiehao;OU Guodong(Guangdong Institute for Drug Control,Guangzhou 510663,China)
出处
《中国药品标准》
CAS
2021年第6期536-540,共5页
Drug Standards of China
关键词
洁净实验室
悬浮粒子
分布
限度
监测
clean operating laboratory
suspended particles
distribution
limit
monitor
