文档介绍：无菌工艺培训默沙东清洁模块CLEANINGMODULE*OBJECTIVES目的Attheendofthismodule:在完成此模块培训后应明白:*CLEANING清洁CleaningwithinaPharmaceuticalprocessingplantisacriticalactivity清洁对一个制药厂来说是一个关键工序Theremustbededicatedequipmentforthecleaningprocess必须明确清洁程序所使用的设备Detailedproceduresonhowtoclean,whichdisinfectantstouseandthedilutionstobeusedforthecleaningprocess应有相应规程来详细说明:清洁方法,清洁程序所使用的消毒剂及其配制。WHY?清洁模块CLEANINGMODULE*CLEANING 清洁Cleaninghastobeavalidatedprocess清洁应是一个已验证的程序Cleaninghastobedocumentedthesameasanyotheractivity清洁应和其它工序一样,有相关的记录为什么清洁如此重要WHYISCLEANINGSOIMPORTANT???清洁模块CLEANINGMODULE*CLEANING–ITSPURPOSE -Thiscanbeupto7daysfromthedayitwascleaned(HoldTime)确保洁净区已清洁,为下次使用做好准备,清洁有效期(清洁保持期)为7天(从清洁当天开始计算)清洁模块CLEANINGMODULE*CLEANING–E 清洁的作用CleaningtheCleanroomcorrectlywillhelptomaintainlowlevelsofparticulateandmicrobialcontaminationinthearea正确的清洁洁净室有利于保持洁净室内的尘埃粒子和微生物污染处于较低水平Ensuretheareaiscleanforthe7dayholdperiod确保洁净室处于清洁有效期内(7天)TheeffectivenessofthecleaningprocesscanbemonitoredthroughtheenvironmentalmonitoringsystemandthePMS清洁程序的效果可通过环境监测和PMS来监测清洁模块CLEANINGMODULE*CLEANINGMODULE 清洁模块我们将要学****的内容:Reviewthedisinfectantsusedinthearea回顾我们在洁净区使用的消毒剂Equipmentusedtocleanthearea所使用的清洁设备Techniquesusedtoclean清洁技术Whytheyaresoimportant为什么上述项目很重要WHATWILLWELEARN?清洁模块CLEANINGMODULE*WHATAREDISINFECTANTS anisms消毒剂是由抗菌药物配制而成,用于消灭微生物Disinfectionmaybedefinedas:anismswhichmaycauseinfection消毒可被定义为:清洁那些可能会造成传染的部分或全部的病原微生物清洁模块CLEANINGMODULE*DISINFECTANTSWEUSE 我们使用的消毒剂Vesphene®llstVesphene碱性苯酚消毒剂LpHst®LpH酸性的苯酚消毒剂Klercide70/30®Klercide杀孢子剂Spor-Klenz®Spor-Klenz杀孢子剂清洁模块CLEANINGMODULE*Vesphene®llst 碱性苯酚消毒剂ProcessVesphene®llstisusedintheGradeCandA/BareasProcessVesphene®llst用于C级区和A/B级洁净区Vesphene®llstisaonestepalkalinephenolicdisinfectantVesphene®llst是一步碱性酚类消