中英对照-APIC 原料药厂清洁验证指南：6.0清洁工艺的控制.doc

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1、6.CONTROLOFCLEANINGPROCESS清洁工艺的控制Inordertovalidateacleaningprocess,thecleaningprocessneedstoberepeatableandsufficientlyrobustfortheto-be-cleanedload.Itshouldbeclearwhichstepsareconsideredpartoftheproductionprocess/unitoperationandwhicharepartofthecleaningprocess,forexampleifthepre-rinseorwash-outwhi

2、chmayberoutinelyappliedtobringtheequipmentinagoodstartingpositionispartoftheoverallcleaningprocessornot.Anotherexampleisthecleaningofchromatographycolumns,whicharetypicallycleanedwithbufferspriortothechromatographyskidcleaning.为了对清洁工艺进行验证，清洁程序应是可重复的，针对将要清洁的负载，具有足够的清洁能力。要清楚说明，哪个操作是生产工艺/单元操作的一部分，哪个是清洁

3、工艺的一部分。例如，对设备进行前期冲洗或淋洗，以使其成为一个洗前的起始状态，是否是整个清洁工艺的一部分。Toassurerepeatabilityandrobustnessofthecleaning,adequatecleaninginstructionsarerequired.为保证清洁的可重复性和耐用性，要制订充分的清洁指令。Formanualcleaning,thisistypicallyaccomplishedbysufficientlydetailedcleaninginstructions,includinganunambiguousdescriptionoftheattribut

4、estobeusedandhowtohandlethese,togetherwithadequatetraining.对于手动清洁，一般是根据详细的清洁指令来完成的，其中包括对清洁方法的清楚描述，如何操作，并需要进行充分的培训。Thedetaileddescriptionshouldconsider:1.thesystemboundaries2.cleaningagents/solventstobeused3.volumesandorconcentrations4.refluxorrinsetimes,andtemperatures5.thesequenceofcleaningstepsorp

5、re-definedrepeats6.inprocessanalyses7.descriptionofpumpsused(ifneeded)8.sampleinstructions(ifneeded)详细描述应考虑1、系统界限2、使用的清洁剂/清洁溶剂3、体积和/或浓度4、冲洗或淋洗时间、温度5、清洁步骤或预定重复顺序6、过程中检测7、所用泵的描述（必要时）8、取样指令（必要时）Forautomatedcleaningsthisshouldbeensuredbytheequipmentdesigntogetherwiththecleaningsoftware,cleaningrecipeand

6、built-incontrolmechanisms.要保证自动化清洁设备设计中包括了清洁软件、清洁配方和内置控制结构。Forautomatedsystems,itisexpectedthatacleaninginstructioncovers:对于自动化设备，要求清洁指令覆盖以下内容：1)Theappliedcleaningphases,forexampleonce-throughversusre-circulatingversussoakversusreflux-moderinse/washphases所采用的清洁工序，例如一过性、再循环、浸泡、回流方式淋洗/冲洗工序2)Thesequenc

7、esofthecleaningphases清洁工序的顺序3)Timeofeachofthecleaningphases各清洁工序的时间4)Actionappliedduringthecleaningprocess.Notethatthemechanicalaction/impactisoftenflow/pressurerelated(e.g.ifsprayballsarebeingused).在