微生物鉴定技术在无菌药品生产企业中的应用

微生物鉴定技术在无菌药品生产企业中的应用

收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2012-01-25

Application of Microbe Technology in The Industry of Sterile Medicine

Received:1900-01-01 Revised:1900-01-01 Online:2012-01-25

摘要/Abstract

摘要： 目的:为无菌药品生产企业建立一种准确、快速的微生物鉴定方法,用于完善质量管理体系.方法:(1)分别采用API试剂条和分子生物学技术对6株标准菌和10株环境随机获得菌进行鉴定,确认其在无菌药品生产企业应用的适用性;(2)建立环境微生物数据库模型,探讨无菌生产企业环境微生物的一般规律;(3)分别对无菌药品污染溯源调查和环境偏差调查进行举例分析,探讨微生物鉴定技术在无菌药品生产企业中的应用价值.结果:集成应用分析生物学技术和生化鉴定技术所建立的微生物鉴别技术能够有效地应用于无菌药品生产企业,能够有效解决污染溯源、纠偏等实际问题.结论:建立适合无菌药品生产企业日常监控的微生物鉴别技术是十分必要的,我国制药企业应尽快掌握相关生物学技术并建立微生物鉴定技术,以提升和完善药品的GMP管理水平.

Abstract: Objective:Set up a fast and precise assay method for sterile products enterprise,to perfect the qulity management system.Methods:(1)Use API article reagent and Protocols in Molecular Biology separately to test 6 cosmetics and 10 bacterial gained randomly,to make sure it is applieable in the sterile products enterprise;(2)Set up Environmental microbial database model,discussing the general rules to tne microbial environment of sterile products enterprise;(3)Give examples to the sterile products pollution source survey and environmental investigation,discuss the values of assay method in sterile products enterprise.Results:Pathogenic microorganism technology under Biological technology and biochemical identification technology can be effevctively used in sterile products enterprise,and can effectively solve the problems of pollution and correcting errors.Conclusion:It’s necessary to set up assay method for sterile products enterprise.Company of ou=r country should master such technology to improve and pefect gmp management.

. 微生物鉴定技术在无菌药品生产企业中的应用[J]. .

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