摘要
目的:为药品生产企业洁净环境管理的风险评估和控制提供参考。方法:筛选2020、2021两年我院接受委托的101家生产企业洁净检测数据,并参照相关标准,收集洁净室数量及面积、温度、相对湿度、换气次数、静压差、沉降菌、悬浮粒子,并分析现场检测过程中发现的问题。结果:共检测洁净区202个,洁净室2 874间,其中D级洁净室1 723间,C级洁净室862间,A级洁净室289间。各D级和C级洁净室的温度、相对湿度、换气次数、尘埃粒子数均符合要求;有静压差要求的房间分别有202间和279间,静压差在11~20 Pa范围内,均符合要求;分别有323间和92间洁净室检出沉降菌,检出菌数分别以1~2个/皿(325间)及1个/皿(13间)为主,主要为一更间或缓冲间为主。结论:生产企业在日常生产过程中,应注重洁净室(区)的设计和施工,加强洁净环境技术参数的监测和设备的日常维护管理,以促进生产的高效运行,保障产品质量。
Objective:It provides reference for the risk assessment and control of clean environment management in drug manufacturing enterprises.Methods:The cleaning test data of 71 manufacturers in 2020,2021 were selected,and the number and area of clean rooms,temperature and relative humidity,ventilation frequency,static pressure difference,number of sedimention bacteria and dust articles were collected according to relevant standards,and the problems found in the field of cleaning test site were analyzed.Results:A total of 202 clean zones and 2874 clean rooms were tested,including 1723 class D clean rooms and 862 class C clean rooms.The temperature,relative humidity,ventilation frequency and dust particle number of each class D and class C clean room met the requirements.Among the class D and class C clean rooms,202 and 279 clean rooms which static pressure difference met the equirements,and the test results was in the range of 11-20 Pa;323 and 92 clean rooms were detected with sedimentation bacteria,mainly 1 or 2 each culture vessel(325 clean rooms)and 1 each culture vessel(13 clean rooms)were detected,respectively.The rooms where sedimentation bacteria were detected were mainly two watch rooms and buffer rooms.Conclusion:In the process of daily production,manufacturers should strengthen the monitoring of cleaning technical parameters and the maintenance management of equipments,and pay attention to the design and construction of clean room(zone),so as to promote the efficient operation of production and ensure the quality of products.
作者
黄伟
季大伟
HUANG Wei;JI Dawei(Taizhou Institute for Drug Control,Jiangsu Taizhou 225300,China)
出处
《中国药品标准》
CAS
2023年第2期134-137,共4页
Drug Standards of China
关键词
分析
生产企业
洁净室
洁净检测
analysis
manufacturers
clean rooms
cleaning test
