化工制药厂洁净区微生物控制浅析  

Analysis of Microbial Control in Clean Area of Chemical Pharmaceutical Factory

作　　者：匡海奇 余展旺[1] 李远文[1] Kuang Haiqi;Yu Zhanwang;Li Yuanwen(School of Applied Biology,Shenzhen Institute of Technology,Shenzhen 518116,China)

机构地区：[1]深圳技师学院应用生物学院,广东深圳518116

出　　处：《山东化工》2021年第15期99-101,共3页Shandong Chemical Industry

摘　　要：药品安全关系国计民生,随着国家十四五规划的提出,提高食品药品等关系人民健康产品和服务的安全保障水平迫在眉睫,化学药的微生物控制一直是老大难问题,其中生产环境和设备、生产操作及质量管理体系的完善贯穿了药品生产的始终,即化学药微生物水平的控制在于良好的质量体系的实施、生产环境的保证、生产环节的监控、有效的趋势分析和数理统计,本文就微生物的过程控制从硬件和软件两个大的方面分别阐述了洁净区生产过程中的质量理念的嵌入方法,并阐述了根据有效的数据分析,进而针对不同微生物,可以采取对应的消毒措施,更好地指导洁净区的清洁卫生和生产实践,为药品生产保驾护航。Drug safety is related to the national economy and the people's livelihood.With the proposal of the national 14th five year plan,it is urgent to improve the safety level of food and drugs and other products and services related to people's health.The microbial control of chemical drugs has always been a long-standing problem.The improvement of production environment and equipment,production operation and quality management system runs through the whole process of drug production,that is,the microbial level of chemical drugs In this paper,the embedded method of quality concept in the production process of clean area is described from two aspects of hardware and software.According to the effective data analysis,the embedded method of quality concept in the production process of clean area is described,Corresponding disinfection measures can be taken to better guide the cleaning and production practice of the clean area and escort the drug production.

关 键 词：十四五规划 化学制药 洁净区 微生物控制 验证 质量管理体系 

分 类 号：TQ086[化学工程]