文章摘要
黄伟,季大伟.生产企业洁净检测分析[J].中国药品标准,2023,24(2):
生产企业洁净检测分析
Analysis of Cleaning Test for Manufacturers
投稿时间:2022-12-08  修订日期:2023-03-29
DOI:
中文关键词: 分析  生产企业  洁净室  洁净检测
英文关键词: analysis  manufacturers  clean rooms  cleaning test
基金项目:
作者单位E-mail
黄伟 泰州市药品检验院 1920158039@qq.com 
季大伟* 泰州市药品检验院 26181548@qq.com 
摘要点击次数: 318
全文下载次数: 290
中文摘要:
      目的:为医药领域生产企业的高效生产运行提供参考。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:共检测洁净室202个,洁净室2874间,其中D级洁净室1723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,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。
英文摘要:
      Abstract Objective:To provide a reference for the efficient production and operation of medicine field manufacturers. Methods:The cleaning test data of 71 manufacturers in 2020 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, including1723 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 static pressure difference was in the range of 11–20 Pa,323 and 92 clean rooms were detected with sedimentation bacteria, mainly one or two each culture vessel(325 clean rooms) and one each culture vessel(13 clean rooms) were detected, respectively. The rooms where sedimentation bacteria were detected were mainly two watch roomsand 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.
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