无菌工艺培训(默沙东)

清洁模块CLEANINGMODULE1ASEPTICPROCESSING

无菌工艺CLEANROOM–CLEANINGEQUIREMENT洁净室-清洁设备清洁模块CLEANINGMODULE2OBJECTIVES目的Attheendofthismodule:在完成此模块培训后应明白：Understandthematerialsanddisinfectantsused.所使用的材料及消毒剂Whywecleaninaparticularway为什么我们用特殊的方式来清洁Howtocleaninthecorrectway.如何正确的清洁清洁模块CLEANINGMODULE3CLEANING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CLEANINGMODULE4CLEANING

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CLEANINGMODULE5CLEANING–ITSPURPOSE

清洁目的Tokillanymicro-organismsthatarepresent杀灭任何存在的微生物Toremoveasmanyparticlesorcontaminatesaspossiblefromthearea.尽可能的将洁净区的尘埃粒子或污染清除Ensuretheareaiscleanforitsnextuse-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CLEANINGMODULE6CLEANING–THEOUTCOME

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CLEANINGMODULE7CLEANINGMODULE

清洁模块我们将要学习的内容：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CLEANINGMODULE8WHATAREDISINFECTANTS

什么是消毒剂Disinfectantsareantimicrobialagentsthatareappliedtoobjectstodestroythemicro-organisms消毒剂是由抗菌药物配制而成，用于消灭微生物Disinfectionmaybedefinedas:Cleaninganarticleofsomeorallofthepathogenicorganismswhichmaycauseinfection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CLEANINGMODULE9DISINFECTANTSWEUSE

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CLEANINGMODULE10

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是一步碱性酚类消毒剂Thepacksaresterileandhavelotnumbersandexpirydatesfortraceability包装是经过消毒的，贴有批号，标示有有效期用于追溯清洁模块CLEANINGMODULE11

Vesphene®llst

Vesphene碱性苯酚消毒剂

Vespheneispackedinaready-to-usesachetwithaspecificdilutionrateVesphene是按即用型消毒剂包装的，按特定的稀释比例配制Vesphenekillsabroadspectrumofmicro-organismswithoutharmingsurfacesVesphene可杀灭广谱微生物，不会损害各种表面WhenVespheneisdiluted,thisalkalinedisinfectanthasapHrangeof10.4-10.6

当Vesphene被稀释时，其碱性消毒剂的pH范围为10.4-10.6

清洁模块CLEANINGMODULE12LpHst®

LpH酸性的苯酚消毒剂ProcessLpHst®isusedintheGradeCandA/BareasProcessLpHst®用于C级区和A/B级洁净区LpHst®isaonestepacidicphenolicdisinfectantLpHst®是一步酸性酚类消毒剂Thepacksaresterileandhavelotnumbersandexpirydatesfortraceability包装是经过消毒的，贴有批号，标示有有效期用于追溯清洁模块CLEANINGMODULE13LpHst®

LpH酸性的苯酚消毒剂LpHispackedinaready-to-usesachetwithaspecificdilutionrateLpH是按即用型消毒剂包装的，按特定的稀释比例配制LpHstkillsabroadspectrumofmicro-organismswithoutharmingsurfacesLpH可杀灭广谱微生物，不会损害各种表面WhenLpHisdiluted,thisacidicdisinfectanthasapHrangeof2.6to3.0当LpH被稀释时，其酸性消毒剂的pH范围为2.6–3.0

清洁模块CLEANINGMODULE14DISINFECTANTROTATION

消毒剂轮换Vesphene®llstisanalkalinedisinfectantVesphene®llst为碱性消毒剂LpHst®isanacidicdisinfectantLpHst®为酸性消毒剂Rotationofdisinfectantsensuresthatthatmicro-organismsdon’tbuildupatolerancetothedisinfectant消毒剂的轮换使用应确保微生物不会对消毒剂产生抗性清洁模块CLEANINGMODULE15Klercide70/30®

Klercide杀孢子剂Klercide70/30®isa70%IPAsterilereadytousesprayKlercide70/30®为70%的无菌IPA（异丙醇），可直接使用70%IPAand30%deionisedwater由为70%的IPA（异丙醇）和30%的去离子水配制而成Thebottlesaregammairradiatedanddoublebagged盛装用的瓶子经伽马射线灭菌，有双重胶塞Bottleshaveabatchnumberandexpirydate-onceopenedtheywillhaveaONEmonthshelflife瓶身贴有批号，标示有有效期，开封后有效期为一个月清洁模块CLEANINGMODULE16Klercide70/30®

Klercide杀孢子剂Workstokillmicro-organismsbutrequiresacontacttimetobeeffective用于杀灭微生物，生效要求一定的接触时间Quickandeasytouse简单便于使用Hasanumberofusesonsite广泛用于生产现场的消毒：Eg.usedinGradeA/Basglovedhandssanitiser例如：用于A/B级区手套的消毒Eg.forcleaningorwipingdownofequipment例如：用于设备清洁擦拭清洁模块CLEANINGMODULE17

Spor-Klenz®

Spor-Klenz杀孢子剂

Spor-Klenz®isareadytousesporcidaldisinfectantSpor-Klenz®为配制好的杀孢子消毒剂，可直接使用Effectiveatmicrobialcontrolofbacteria,fungi,virusesandbacterialspores对微生物控制（细菌，真菌，病毒和细菌孢子）有效UsedatBiotechPlantasaspraydisinfectantforequipmentgoingintotheGradeA/Bareathatcannotbeautoclaved.Orwhentoolsareneededinabreakdownsituation在生物技术工厂当做喷洒消毒剂来对那些进入A/B级洁净区而不能通过灭菌柜灭菌的设备的消毒，或在设备故障时，用于对维修工具的消毒清洁模块CLEANINGMODULE18DISINFECTANTSWEUSE

我们所使用的消毒剂SPOR-KLENZVESPHENE/LpH醇类ALCOHOLSEFFICENCY消毒效果

Disinfectantscannotsterilisetheobjectorarea消毒剂不能灭菌物体或洁净区清洁模块CLEANINGMODULE19DIFFERENTDISINFECTANTS

各种消毒剂Alcohols醇类OxidizingAgents氧化剂Phenolics酚类QuaternaryAmmonium季铵清洁模块CLEANINGMODULE20DIFFERENTDISINFECTANTS

各种消毒剂Alcohols(IPA)havewidemicrobicidalactivity,arenoncorrosivetosurfaces醇类(IPA)

对广泛的微生物有效，对各种表面不会有腐蚀效果Theyleavelittleresidueduetotheevaporation可挥发，残留量小Alcohols(IPA)arenoteffectiveagainstfungalorbacterialspores醇类(IPA)对真菌或细菌孢子无效清洁模块CLEANINGMODULE21DIFFERENTDISINFECTANTS

各种消毒剂Oxidizingdisinfectantsaffectthecellmembrane,thisleadstothedeathofthemicro-organism氧化消毒剂可影响微生物的细胞膜，从而导致微生物的死亡SodiumHypochloriteandChlorineareoxidizingagents次氯酸钠和氯为氧化剂HouseholdexampleofthesewouldbeBleach

家用的消毒剂也有这类型的，例如：漂白剂清洁模块CLEANINGMODULE22DIFFERENTDISINFECTANTS

各种消毒剂Phenolicsaretheactiveingredientinsomedisinfectantsandmouthwashes酚类是一些消毒剂和漱口水的活性组成部分Theyareeffectiveatkillingabroadspectrumofbacteria对广谱细菌能够有效杀灭Theydonotharmsurfacesbutthereisresidualbuildup对各种表面没有危害，但是存在残留清洁模块CLEANINGMODULE23DIFFERENTDISINFECTANTS

各种消毒剂Quaternaryammoniumsareeffectiveagainstbacteriabutnotagainstsomepseudomonas(water)bacteria季铵对细菌有效，但对一些假单胞菌和水生细菌无效Theyhaveresidualbuildup存在残留清洁模块CLEANINGMODULE24EFFECTIVENESSOFDISINFECTANTS

消毒剂消毒效果Theeffectivenessofadisinfectantsisdonebycomparingitagainstaknownstandard.消毒剂的效果是通过与已知标准比较来确认的Phenolisthestandardandtheratingsystemiscalledthe“PhenolCoefficient”已知标准为苯酚，其评级系统被称为“苯酚系数”ThetestdisinfectantiscomparedwithPhenolonastandardmicrobe消毒剂的消毒效果测试是通过对标准微生物进行消毒，与苯酚对比来确认清洁模块CLEANINGMODULE25EQUIPMENTUSEDTOCLEAN–VACUUMCLEANER

所使用的清洁设备-真空吸尘器TheVacuumcleanerusedintheCleanroomisdifferentfromadomesticvacuumcleaner洁净室所使用的真空吸尘器不同于家用真空吸尘器ThevacuumisfittedwithaHEPAfilterwhichfilterstheexhaustairbeingdischargedintheCleanroom洁净室所使用的真空吸尘器配备有HEPA过滤器，用于过滤从洁净室排除的空气TheHEPAfilteronthevacuumischangedevery6months吸尘器中的HEPA过滤器每6个月更换一次清洁模块CLEANINGMODULE26EQUIPMENTUSEDTOCLEAN–MOPHEADS/WIPES/IPA

所使用的清洁设备-拖把头/抹布/IPAThemopheadsarefoam拖把头材质为泡沫塑料Themopheadiscoveredwithwipestoensurepiecesoffoamarenotdetachedduringthecleaningprocess拖把头上覆盖有抹布，以确保在清洁过程中泡沫塑料不会分离开来Thewipesarelintfreetoensurenoparticlesareshedduringcleaning抹布为无绒材质，以确保在清洁过程中不会有微粒脱落Thewipesaregammairradiatedtoensuresterility抹布应通过伽马曲线灭菌来确保无菌性清洁模块CLEANINGMODULE27EQUIPMENTUSEDTOCLEAN–MOPBUCKETS/HANDLES

所使用的清洁设备-拖把桶/拖把杆Plasticbucketswithstainlesssteelwringers拖把桶为塑料材质，提手为不锈钢材质Mophandlesarealuminumwithplasticendsandheadfittings拖把杆为铝材质，杆末端为塑料材质的杆套Equipmentshouldbecheckedregularly–iftheplastichasdeepscratchesorappearsbrittleitshouldbereplaced设备应进行定期检查，如塑料存在深的刮痕或有老化变脆的现象，应进行更换清洁模块CLEANINGMODULE28HOWDOWEPREPARETOCLEANTHEAREA?

我们如何准备洁净室的清洁Componentshavebeenautoclaved–mopheads,handles,bucketsandwringersareassembled相关清洁工具配件应通过灭菌柜传入洁净室，例如：拖把头，拖把杆，拖把桶，不锈钢提手等Thedisinfectantsarereadytouseinasterilepouch消毒剂已装入无菌袋备用WipesandIPAaresterileandreadytouse抹布和IPA已灭菌备用下一步是什么？WHATISTHENEXTSTEP?清洁模块CLEANINGMODULE29HOWDOWEPREPARETOCLEANTHEAREA?

我们如何准备洁净室的清洁ThenfiltertheWFIintothebuckets过滤WFI到拖把桶中Addthedisinfectantandmixthesolution加入消毒剂，混合Starttoclean开始清洁是上面这么回事么？ISTHISWHATHAPPENS?清洁模块CLEANINGMODULE30CLEANING

清洁为什么？TheaccuratedispenseofWFIiscriticalWFI的放入量是非常关键的ThedisinfectantsachetmustbeemptiedcompletelyandrinsedinWFI消毒剂小包装袋内的消毒剂必须完全倒出，并用WFI对包装袋进行冲洗WFIshouldnotbeaddedtothedisinfectant应避免WFI被倒入消毒剂盛装容器中Thesolutionmustbemixedbeforeproceeding在执行清洁前，配制的消毒液应混合均匀WHY?清洁模块CLEANINGMODULE31CLEANING

清洁原因WFIdilutionfactorsof1:128or1:256areaccurateprocessmeasurements–ofthesolution:WFI稀释系数为1:128或1:256为准确的消毒液配置比例Ifitstooweakitwillnotbeaseffectiveatkillingthemicro-organisms消毒剂浓度太低会降低灭微生物效果Ifitstoostrongitcoulddamagetheequipmentiecauserust,leaveresiduesthatcouldaffecttheequipmentoritmaynotbeeffective浓度太高会破坏设备，例如：造成生锈，残留的消毒剂会影响设备，影响灭微生物效果REASONWHY清洁模块CLEANINGMODULE32CLEANING

清洁原因Thedisinfectantsachetsareanexactvolumetobea1:128or1:256dilution小包装的消毒剂的装量应适用1：128或1：256的比例稀释Ifvolumeofsachetsarenotusedthesolutionwillbeagaineithertooweakortoostrong如果小包装的装量不符合此比例系数，所配置的溶液就可能会浓度太低或太高Rinsingthesachetsensureallthecontentshavebeenemptiedfromsachet用WFI冲洗小包装袋，应确保所有的内容物都被冲洗出袋子REASONWHY清洁模块CLEANINGMODULE33CLEANING

清洁原因WFIisaddedfirstasthedisinfectantsachetsareconcentrated.Asoneortwodropssplashedcould:因为消毒剂的浓度很高，应先加入WFI，如果有一两滴消毒剂洒落可能会造成：Alterthedilutionfactor稀释因数的改变Erodetheequipmentorsurfacesthatithassplashedontobecauseitissoconcentrated因为浓度高，腐蚀掉落在的设备或表面REASONWHY清洁模块CLEANINGMODULE34CLEANING-NOTES

清洁注意事项Mixingthesolutionbeforeproceedingensuresahomogeneousmix在执行清洁前，确保消毒液混合均匀Ensuresthedilutionfactoriscorrectbeforeapplyingtoequipmentandsurfaces在使用消毒液清洁设备和各种表面，确保稀释因数正确Weaksolutiondoesn’tkillthemicro-organsims消毒液浓度太低的话，不能灭杀微生物Strongsolutionsharmsthesurfaces消毒液浓度太高，会损坏表面REASONWHY清洁模块CLEANINGMODULE35CLEANINGPROCESS

清洁程序-洁净区清洁AREACLEANING清洁模块CLEANINGMODULE36VACUUMPROCESS

真空吸尘器清洁Vacuumingisdoneattheendofabatchrun在批次运行结束时使用真空吸尘器清洁Itcollectslargeritemsfromtheflooriestoppers,piecesofautoclavetape在这个过程中会收集地上较大体积的物体，例如：胶塞，灭菌指示带EffectiveatlargeparticleremovaltheHEPAfilterinthevacuumpreventstheredepositofparticles有效清除大颗粒，在真空吸尘器清洁时移除HEPA过滤器，以避免尘埃粒子的再沉积清洁模块CLEANINGMODULE37MOPPINGPROCESS

拖把擦拭Wetmoppingisthemosteffectivemethodforremovingparticle

contaminantsfromthearea.用湿拖把拖地，是移除洁净区的尘埃粒子污染是最有效的方法Thetwobucketmethodensuresthattheredepositofcontaminatesiscontrolled.采用两拖把桶的方式，来确保污染物再沉积的控制清洁模块CLEANINGMODULE38TWOBUCKETSYSTEM

两拖把桶系统BucketOne(1)isusedtoapplythefreshdisinfectantsolution桶一(1)用于更新消毒液BucketTwo(2)isusedtorinsethemop,andtoholdtheuseddisinfectantsolution桶二(2)用于清洗抹布和盛装使用过的消毒液12清洁模块CLEANINGMODULE39SURFACECONTACT

表面接触Fortheeffectiveremovalofcontaminantstheremustbe100%

contactonthesurfaceareawiththemopandthedisinfectant为确保有效移除污染物，应用抹布和消毒液100%接触所清洁表面Frames,hingesaredifficulttocleanandspecialattentionshouldbepaidtotheseareas一些难以清洁的表面，例如：架子，铰链等，清洁时应对这些区域特别注意清洁模块CLEANINGMODULE40YOUMISSEDME!你把我给忘了！！！AAGH啊啊啊DOORFRAME门框HINGE铰链清洁模块CLEANINGMODULE41MOPPINGISSUES

擦拭注意事项Overwettingofthemopheadcanredepositthecontaminants拖把头抹布太湿了会造成污染物的再沉积

这是为啥呢？

HOW?清洁模块CLEANINGMODULE42MOPPINGISSUES

擦拭注意事项 Wetthemophead湿的拖把头 Mopthesurface擦拭表面

多的水ExcesswaterCONTAMINANTSFROMCLEANING清洁造成污染清洁模块CLEANINGMODULE43MOPPINGTECHNIQUES

擦拭技巧DRIEST尽量拧干WETTEST最湿CLEANIEST清洁效果最好DIRTIEST还是埋汰清洁模块CLEANINGMODULE44MOPPINGTECHNIQUESFORCEILINGS

擦拭技巧-对天花板Useunidirectionalstrokesthiscanbelefttoright,orrighttoleftbutnotmixed单向擦拭，可以从左到右，也可以从右到左，但是，不可以一会向左一会向右混合！AvoidoverwettingofmopheadassplashescouldlandontopofLAFcartorotherequipmentinthearea避免使用过湿的拖把，水渍可能会溅落到洁净区内层流罩或其他设备上清洁模块CLEANINGMODULE45MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-对墙面和窗户Useunidirectionalstrokes,thismustbefromTOPtoBOTTOM单向擦拭，必须从上到下Strokes

mustbeOVERLAPPING擦拭必须重叠

这是为什么呢？WHY?清洁模块CLEANINGMODULE46MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-对墙面和窗户Themopheadshouldberinsedoffandfreshdisinfectantappliedregularly拖把头应定期冲洗和更新消毒液WHY?清洁模块CLEANINGMODULE47MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-对墙面和窗户YoushouldNOTbeabletocleanawholelengthofwallwithoneapplicationofdisinfectant你不可能在使用一次消毒液的情况下就将整个墙面清洁完WHY?清洁模块CLEANINGMODULE48MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-对墙面和窗户TheCleaningprocessisCRITICALtothearea,thepaceshouldbeslowanddeliberate,thesameasnormaloperations清洁程序对洁净区来说是非常关键的，清洁速度应慢，清洁应仔细，和正常的操作一样WHY?清洁模块CLEANINGMODULE49MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-对墙面和窗户ThepurposeofCleaningistoremoveasmanyparticlesorcontaminatesaspossiblefromthearea清洁的目的在于尽可能的将洁净区的尘埃粒子和污染物移除Whenyourusharound,yousweatandgenerateparticles.当你在洁净室东奔西跑的时候，你会流汗，产生尘埃粒子清洁模块CLEANINGMODULE50PARTICLEGENERATION

尘埃粒子的产生清洁模块CLEANINGMODULE51WIPINGSURFACES

擦拭表面Whenwipingtablesorsurfacesuseunidirectionalstrokes

在擦拭桌子或表面时应单向操作Strokesshouldbeslightlyoverlapping擦拭应稍微重叠Refoldwipeaftereachpass–sosurf