無(wú)菌工藝培訓(xùn)(默沙東)

清潔模塊CLEANINGMODULE1ASEPTICPROCESSING

無(wú)菌工藝CLEANROOM–CLEANINGEQUIREMENT潔凈室-清潔設(shè)備清潔模塊CLEANINGMODULE2OBJECTIVES目的Attheendofthismodule:在完成此模塊培訓(xùn)后應(yīng)明白：Understandthematerialsanddisinfectantsused.所使用的材料及消毒劑Whywecleaninaparticularway為什么我們用特殊的方式來(lái)清潔Howtocleaninthecorrectway.如何正確的清潔清潔模塊CLEANINGMODULE3CLEANING清潔CleaningwithinaPharmaceuticalprocessingplantisacriticalactivity清潔對(duì)一個(gè)制藥廠來(lái)說(shuō)是一個(gè)關(guān)鍵工序Theremustbededicatedequipmentforthecleaningprocess必須明確清潔程序所使用的設(shè)備Detailedproceduresonhowtoclean,whichdisinfectantstouseandthedilutionstobeusedforthecleaningprocess應(yīng)有相應(yīng)規(guī)程來(lái)詳細(xì)說(shuō)明：清潔方法，清潔程序所使用的消毒劑及其配制。

WHY?清潔模塊CLEANINGMODULE4CLEANING

清潔Cleaninghastobeavalidatedprocess清潔應(yīng)是一個(gè)已驗(yàn)證的程序Cleaninghastobedocumentedthesameasanyotheractivity清潔應(yīng)和其它工序一樣，有相關(guān)的記錄為什么清潔如此重要WHYISCLEANINGSOIMPORTANT???清潔模塊CLEANINGMODULE5CLEANING–ITSPURPOSE

清潔目的Tokillanymicro-organismsthatarepresent殺滅任何存在的微生物Toremoveasmanyparticlesorcontaminatesaspossiblefromthearea.盡可能的將潔凈區(qū)的塵埃粒子或污染清除Ensuretheareaiscleanforitsnextuse-Thiscanbeupto7daysfromthedayitwascleaned(HoldTime)確保潔凈區(qū)已清潔，為下次使用做好準(zhǔn)備，清潔有效期（清潔保持期）為7天（從清潔當(dāng)天開始計(jì)算）清潔模塊CLEANINGMODULE6CLEANING–THEOUTCOME

清潔的作用CleaningtheCleanroomcorrectlywillhelptomaintainlowlevelsofparticulateandmicrobialcontaminationinthearea正確的清潔潔凈室有利于保持潔凈室內(nèi)的塵埃粒子和微生物污染處于較低水平Ensuretheareaiscleanforthe7dayholdperiod確保潔凈室處于清潔有效期內(nèi)（7天）TheeffectivenessofthecleaningprocesscanbemonitoredthroughtheenvironmentalmonitoringsystemandthePMS清潔程序的效果可通過(guò)環(huán)境監(jiān)測(cè)和PMS來(lái)監(jiān)測(cè)清潔模塊CLEANINGMODULE7CLEANINGMODULE

清潔模塊我們將要學(xué)習(xí)的內(nèi)容：Reviewthedisinfectantsusedinthearea回顧我們?cè)跐崈魠^(qū)使用的消毒劑Equipmentusedtocleanthearea所使用的清潔設(shè)備Techniquesusedtoclean清潔技術(shù)Whytheyaresoimportant為什么上述項(xiàng)目很重要WHATWILLWELEARN?清潔模塊CLEANINGMODULE8WHATAREDISINFECTANTS

什么是消毒劑Disinfectantsareantimicrobialagentsthatareappliedtoobjectstodestroythemicro-organisms消毒劑是由抗菌藥物配制而成，用于消滅微生物Disinfectionmaybedefinedas:Cleaninganarticleofsomeorallofthepathogenicorganismswhichmaycauseinfection消毒可被定義為：清潔那些可能會(huì)造成傳染的部分或全部的病原微生物清潔模塊CLEANINGMODULE9DISINFECTANTSWEUSE

我們使用的消毒劑Vesphene?llstVesphene堿性苯酚消毒劑LpHst?LpH酸性的苯酚消毒劑Klercide70/30?Klercide殺孢子劑Spor-Klenz?Spor-Klenz殺孢子劑清潔模塊CLEANINGMODULE10

Vesphene?llst

堿性苯酚消毒劑

ProcessVesphene?llstisusedintheGradeCandA/BareasProcessVesphene?llst用于C級(jí)區(qū)和A/B級(jí)潔凈區(qū)Vesphene?llstisaonestepalkalinephenolicdisinfectantVesphene?llst是一步堿性酚類消毒劑Thepacksaresterileandhavelotnumbersandexpirydatesfortraceability包裝是經(jīng)過(guò)消毒的，貼有批號(hào)，標(biāo)示有有效期用于追溯清潔模塊CLEANINGMODULE11

Vesphene?llst

Vesphene堿性苯酚消毒劑

Vespheneispackedinaready-to-usesachetwithaspecificdilutionrateVesphene是按即用型消毒劑包裝的，按特定的稀釋比例配制Vesphenekillsabroadspectrumofmicro-organismswithoutharmingsurfacesVesphene可殺滅廣譜微生物，不會(huì)損害各種表面WhenVespheneisdiluted,thisalkalinedisinfectanthasapHrangeof10.4-10.6

當(dāng)Vesphene被稀釋時(shí)，其堿性消毒劑的pH范圍為10.4-10.6

清潔模塊CLEANINGMODULE12LpHst?

LpH酸性的苯酚消毒劑ProcessLpHst?isusedintheGradeCandA/BareasProcessLpHst?用于C級(jí)區(qū)和A/B級(jí)潔凈區(qū)LpHst?isaonestepacidicphenolicdisinfectantLpHst?是一步酸性酚類消毒劑Thepacksaresterileandhavelotnumbersandexpirydatesfortraceability包裝是經(jīng)過(guò)消毒的，貼有批號(hào)，標(biāo)示有有效期用于追溯清潔模塊CLEANINGMODULE13LpHst?

LpH酸性的苯酚消毒劑LpHispackedinaready-to-usesachetwithaspecificdilutionrateLpH是按即用型消毒劑包裝的，按特定的稀釋比例配制LpHstkillsabroadspectrumofmicro-organismswithoutharmingsurfacesLpH可殺滅廣譜微生物，不會(huì)損害各種表面WhenLpHisdiluted,thisacidicdisinfectanthasapHrangeof2.6to3.0當(dāng)LpH被稀釋時(shí)，其酸性消毒劑的pH范圍為2.6–3.0

清潔模塊CLEANINGMODULE14DISINFECTANTROTATION

消毒劑輪換Vesphene?llstisanalkalinedisinfectantVesphene?llst為堿性消毒劑LpHst?isanacidicdisinfectantLpHst?為酸性消毒劑Rotationofdisinfectantsensuresthatthatmicro-organismsdon’tbuildupatolerancetothedisinfectant消毒劑的輪換使用應(yīng)確保微生物不會(huì)對(duì)消毒劑產(chǎn)生抗性清潔模塊CLEANINGMODULE15Klercide70/30?

Klercide殺孢子劑Klercide70/30?isa70%IPAsterilereadytousesprayKlercide70/30?為70%的無(wú)菌IPA（異丙醇），可直接使用70%IPAand30%deionisedwater由為70%的IPA（異丙醇）和30%的去離子水配制而成Thebottlesaregammairradiatedanddoublebagged盛裝用的瓶子經(jīng)伽馬射線滅菌，有雙重膠塞Bottleshaveabatchnumberandexpirydate-onceopenedtheywillhaveaONEmonthshelflife瓶身貼有批號(hào)，標(biāo)示有有效期，開封后有效期為一個(gè)月清潔模塊CLEANINGMODULE16Klercide70/30?

Klercide殺孢子劑Workstokillmicro-organismsbutrequiresacontacttimetobeeffective用于殺滅微生物，生效要求一定的接觸時(shí)間Quickandeasytouse簡(jiǎn)單便于使用Hasanumberofusesonsite廣泛用于生產(chǎn)現(xiàn)場(chǎng)的消毒：Eg.usedinGradeA/Basglovedhandssanitiser例如：用于A/B級(jí)區(qū)手套的消毒Eg.forcleaningorwipingdownofequipment例如：用于設(shè)備清潔擦拭清潔模塊CLEANINGMODULE17

Spor-Klenz?

Spor-Klenz殺孢子劑

Spor-Klenz?isareadytousesporcidaldisinfectantSpor-Klenz?為配制好的殺孢子消毒劑，可直接使用Effectiveatmicrobialcontrolofbacteria,fungi,virusesandbacterialspores對(duì)微生物控制（細(xì)菌，真菌，病毒和細(xì)菌孢子）有效UsedatBiotechPlantasaspraydisinfectantforequipmentgoingintotheGradeA/Bareathatcannotbeautoclaved.Orwhentoolsareneededinabreakdownsituation在生物技術(shù)工廠當(dāng)做噴灑消毒劑來(lái)對(duì)那些進(jìn)入A/B級(jí)潔凈區(qū)而不能通過(guò)滅菌柜滅菌的設(shè)備的消毒，或在設(shè)備故障時(shí)，用于對(duì)維修工具的消毒清潔模塊CLEANINGMODULE18DISINFECTANTSWEUSE

我們所使用的消毒劑SPOR-KLENZVESPHENE/LpH醇類ALCOHOLSEFFICENCY消毒效果

Disinfectantscannotsterilisetheobjectorarea消毒劑不能滅菌物體或潔凈區(qū)清潔模塊CLEANINGMODULE19DIFFERENTDISINFECTANTS

各種消毒劑Alcohols醇類OxidizingAgents氧化劑Phenolics酚類QuaternaryAmmonium季銨清潔模塊CLEANINGMODULE20DIFFERENTDISINFECTANTS

各種消毒劑Alcohols(IPA)havewidemicrobicidalactivity,arenoncorrosivetosurfaces醇類(IPA)

對(duì)廣泛的微生物有效，對(duì)各種表面不會(huì)有腐蝕效果Theyleavelittleresidueduetotheevaporation可揮發(fā)，殘留量小Alcohols(IPA)arenoteffectiveagainstfungalorbacterialspores醇類(IPA)對(duì)真菌或細(xì)菌孢子無(wú)效清潔模塊CLEANINGMODULE21DIFFERENTDISINFECTANTS

各種消毒劑Oxidizingdisinfectantsaffectthecellmembrane,thisleadstothedeathofthemicro-organism氧化消毒劑可影響微生物的細(xì)胞膜，從而導(dǎo)致微生物的死亡SodiumHypochloriteandChlorineareoxidizingagents次氯酸鈉和氯為氧化劑HouseholdexampleofthesewouldbeBleach

家用的消毒劑也有這類型的，例如：漂白劑清潔模塊CLEANINGMODULE22DIFFERENTDISINFECTANTS

各種消毒劑Phenolicsaretheactiveingredientinsomedisinfectantsandmouthwashes酚類是一些消毒劑和漱口水的活性組成部分Theyareeffectiveatkillingabroadspectrumofbacteria對(duì)廣譜細(xì)菌能夠有效殺滅Theydonotharmsurfacesbutthereisresidualbuildup對(duì)各種表面沒有危害，但是存在殘留清潔模塊CLEANINGMODULE23DIFFERENTDISINFECTANTS

各種消毒劑Quaternaryammoniumsareeffectiveagainstbacteriabutnotagainstsomepseudomonas(water)bacteria季銨對(duì)細(xì)菌有效，但對(duì)一些假單胞菌和水生細(xì)菌無(wú)效Theyhaveresidualbuildup存在殘留清潔模塊CLEANINGMODULE24EFFECTIVENESSOFDISINFECTANTS

消毒劑消毒效果Theeffectivenessofadisinfectantsisdonebycomparingitagainstaknownstandard.消毒劑的效果是通過(guò)與已知標(biāo)準(zhǔn)比較來(lái)確認(rèn)的Phenolisthestandardandtheratingsystemiscalledthe“PhenolCoefficient”已知標(biāo)準(zhǔn)為苯酚，其評(píng)級(jí)系統(tǒng)被稱為“苯酚系數(shù)”ThetestdisinfectantiscomparedwithPhenolonastandardmicrobe消毒劑的消毒效果測(cè)試是通過(guò)對(duì)標(biāo)準(zhǔn)微生物進(jìn)行消毒，與苯酚對(duì)比來(lái)確認(rèn)清潔模塊CLEANINGMODULE25EQUIPMENTUSEDTOCLEAN–VACUUMCLEANER

所使用的清潔設(shè)備-真空吸塵器TheVacuumcleanerusedintheCleanroomisdifferentfromadomesticvacuumcleaner潔凈室所使用的真空吸塵器不同于家用真空吸塵器ThevacuumisfittedwithaHEPAfilterwhichfilterstheexhaustairbeingdischargedintheCleanroom潔凈室所使用的真空吸塵器配備有HEPA過(guò)濾器，用于過(guò)濾從潔凈室排除的空氣TheHEPAfilteronthevacuumischangedevery6months吸塵器中的HEPA過(guò)濾器每6個(gè)月更換一次清潔模塊CLEANINGMODULE26EQUIPMENTUSEDTOCLEAN–MOPHEADS/WIPES/IPA

所使用的清潔設(shè)備-拖把頭/抹布/IPAThemopheadsarefoam拖把頭材質(zhì)為泡沫塑料Themopheadiscoveredwithwipestoensurepiecesoffoamarenotdetachedduringthecleaningprocess拖把頭上覆蓋有抹布，以確保在清潔過(guò)程中泡沫塑料不會(huì)分離開來(lái)Thewipesarelintfreetoensurenoparticlesareshedduringcleaning抹布為無(wú)絨材質(zhì)，以確保在清潔過(guò)程中不會(huì)有微粒脫落Thewipesaregammairradiatedtoensuresterility抹布應(yīng)通過(guò)伽馬曲線滅菌來(lái)確保無(wú)菌性清潔模塊CLEANINGMODULE27EQUIPMENTUSEDTOCLEAN–MOPBUCKETS/HANDLES

所使用的清潔設(shè)備-拖把桶/拖把桿Plasticbucketswithstainlesssteelwringers拖把桶為塑料材質(zhì)，提手為不銹鋼材質(zhì)Mophandlesarealuminumwithplasticendsandheadfittings拖把桿為鋁材質(zhì)，桿末端為塑料材質(zhì)的桿套Equipmentshouldbecheckedregularly–iftheplastichasdeepscratchesorappearsbrittleitshouldbereplaced設(shè)備應(yīng)進(jìn)行定期檢查，如塑料存在深的刮痕或有老化變脆的現(xiàn)象，應(yīng)進(jìn)行更換清潔模塊CLEANINGMODULE28HOWDOWEPREPARETOCLEANTHEAREA?

我們?nèi)绾螠?zhǔn)備潔凈室的清潔Componentshavebeenautoclaved–mopheads,handles,bucketsandwringersareassembled相關(guān)清潔工具配件應(yīng)通過(guò)滅菌柜傳入潔凈室，例如：拖把頭，拖把桿，拖把桶，不銹鋼提手等Thedisinfectantsarereadytouseinasterilepouch消毒劑已裝入無(wú)菌袋備用WipesandIPAaresterileandreadytouse抹布和IPA已滅菌備用下一步是什么？WHATISTHENEXTSTEP?清潔模塊CLEANINGMODULE29HOWDOWEPREPARETOCLEANTHEAREA?

我們?nèi)绾螠?zhǔn)備潔凈室的清潔ThenfiltertheWFIintothebuckets過(guò)濾WFI到拖把桶中Addthedisinfectantandmixthesolution加入消毒劑，混合Starttoclean開始清潔是上面這么回事么？ISTHISWHATHAPPENS?清潔模塊CLEANINGMODULE30CLEANING

清潔為什么？TheaccuratedispenseofWFIiscriticalWFI的放入量是非常關(guān)鍵的ThedisinfectantsachetmustbeemptiedcompletelyandrinsedinWFI消毒劑小包裝袋內(nèi)的消毒劑必須完全倒出，并用WFI對(duì)包裝袋進(jìn)行沖洗WFIshouldnotbeaddedtothedisinfectant應(yīng)避免WFI被倒入消毒劑盛裝容器中Thesolutionmustbemixedbeforeproceeding在執(zhí)行清潔前，配制的消毒液應(yīng)混合均勻WHY?清潔模塊CLEANINGMODULE31CLEANING

清潔原因WFIdilutionfactorsof1:128or1:256areaccurateprocessmeasurements–ofthesolution:WFI稀釋系數(shù)為1:128或1:256為準(zhǔn)確的消毒液配置比例Ifitstooweakitwillnotbeaseffectiveatkillingthemicro-organisms消毒劑濃度太低會(huì)降低滅微生物效果Ifitstoostrongitcoulddamagetheequipmentiecauserust,leaveresiduesthatcouldaffecttheequipmentoritmaynotbeeffective濃度太高會(huì)破壞設(shè)備，例如：造成生銹，殘留的消毒劑會(huì)影響設(shè)備，影響滅微生物效果REASONWHY清潔模塊CLEANINGMODULE32CLEANING

清潔原因Thedisinfectantsachetsareanexactvolumetobea1:128or1:256dilution小包裝的消毒劑的裝量應(yīng)適用1：128或1：256的比例稀釋Ifvolumeofsachetsarenotusedthesolutionwillbeagaineithertooweakortoostrong如果小包裝的裝量不符合此比例系數(shù)，所配置的溶液就可能會(huì)濃度太低或太高Rinsingthesachetsensureallthecontentshavebeenemptiedfromsachet用WFI沖洗小包裝袋，應(yīng)確保所有的內(nèi)容物都被沖洗出袋子REASONWHY清潔模塊CLEANINGMODULE33CLEANING

清潔原因WFIisaddedfirstasthedisinfectantsachetsareconcentrated.Asoneortwodropssplashedcould:因?yàn)橄緞┑臐舛群芨?，?yīng)先加入WFI，如果有一兩滴消毒劑灑落可能會(huì)造成：Alterthedilutionfactor稀釋因數(shù)的改變Erodetheequipmentorsurfacesthatithassplashedontobecauseitissoconcentrated因?yàn)闈舛雀撸g掉落在的設(shè)備或表面REASONWHY清潔模塊CLEANINGMODULE34CLEANING-NOTES

清潔注意事項(xiàng)Mixingthesolutionbeforeproceedingensuresahomogeneousmix在執(zhí)行清潔前，確保消毒液混合均勻Ensuresthedilutionfactoriscorrectbeforeapplyingtoequipmentandsurfaces在使用消毒液清潔設(shè)備和各種表面，確保稀釋因數(shù)正確Weaksolutiondoesn’tkillthemicro-organsims消毒液濃度太低的話，不能滅殺微生物Strongsolutionsharmsthesurfaces消毒液濃度太高，會(huì)損壞表面REASONWHY清潔模塊CLEANINGMODULE35CLEANINGPROCESS

清潔程序-潔凈區(qū)清潔AREACLEANING清潔模塊CLEANINGMODULE36VACUUMPROCESS

真空吸塵器清潔Vacuumingisdoneattheendofabatchrun在批次運(yùn)行結(jié)束時(shí)使用真空吸塵器清潔Itcollectslargeritemsfromtheflooriestoppers,piecesofautoclavetape在這個(gè)過(guò)程中會(huì)收集地上較大體積的物體，例如：膠塞，滅菌指示帶EffectiveatlargeparticleremovaltheHEPAfilterinthevacuumpreventstheredepositofparticles有效清除大顆粒，在真空吸塵器清潔時(shí)移除HEPA過(guò)濾器，以避免塵埃粒子的再沉積清潔模塊CLEANINGMODULE37MOPPINGPROCESS

拖把擦拭Wetmoppingisthemosteffectivemethodforremovingparticle

contaminantsfromthearea.用濕拖把拖地，是移除潔凈區(qū)的塵埃粒子污染是最有效的方法Thetwobucketmethodensuresthattheredepositofcontaminatesiscontrolled.采用兩拖把桶的方式，來(lái)確保污染物再沉積的控制清潔模塊CLEANINGMODULE38TWOBUCKETSYSTEM

兩拖把桶系統(tǒng)BucketOne(1)isusedtoapplythefreshdisinfectantsolution桶一(1)用于更新消毒液BucketTwo(2)isusedtorinsethemop,andtoholdtheuseddisinfectantsolution桶二(2)用于清洗抹布和盛裝使用過(guò)的消毒液12清潔模塊CLEANINGMODULE39SURFACECONTACT

表面接觸Fortheeffectiveremovalofcontaminantstheremustbe100%

contactonthesurfaceareawiththemopandthedisinfectant為確保有效移除污染物，應(yīng)用抹布和消毒液100%接觸所清潔表面Frames,hingesaredifficulttocleanandspecialattentionshouldbepaidtotheseareas一些難以清潔的表面，例如：架子，鉸鏈等，清潔時(shí)應(yīng)對(duì)這些區(qū)域特別注意清潔模塊CLEANINGMODULE40YOUMISSEDME!你把我給忘了?。?！AAGH啊啊啊DOORFRAME門框HINGE鉸鏈清潔模塊CLEANINGMODULE41MOPPINGISSUES

擦拭注意事項(xiàng)Overwettingofthemopheadcanredepositthecontaminants拖把頭抹布太濕了會(huì)造成污染物的再沉積

這是為啥呢？

HOW?清潔模塊CLEANINGMODULE42MOPPINGISSUES

擦拭注意事項(xiàng) Wetthemophead濕的拖把頭 Mopthesurface擦拭表面

多的水ExcesswaterCONTAMINANTSFROMCLEANING清潔造成污染清潔模塊CLEANINGMODULE43MOPPINGTECHNIQUES

擦拭技巧DRIEST盡量擰干WETTEST最濕CLEANIEST清潔效果最好DIRTIEST還是埋汰清潔模塊CLEANINGMODULE44MOPPINGTECHNIQUESFORCEILINGS

擦拭技巧-對(duì)天花板Useunidirectionalstrokesthiscanbelefttoright,orrighttoleftbutnotmixed單向擦拭，可以從左到右，也可以從右到左，但是，不可以一會(huì)向左一會(huì)向右混合！AvoidoverwettingofmopheadassplashescouldlandontopofLAFcartorotherequipmentinthearea避免使用過(guò)濕的拖把，水漬可能會(huì)濺落到潔凈區(qū)內(nèi)層流罩或其他設(shè)備上清潔模塊CLEANINGMODULE45MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-對(duì)墻面和窗戶Useunidirectionalstrokes,thismustbefromTOPtoBOTTOM單向擦拭，必須從上到下Strokes

mustbeOVERLAPPING擦拭必須重疊

這是為什么呢？WHY?清潔模塊CLEANINGMODULE46MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-對(duì)墻面和窗戶Themopheadshouldberinsedoffandfreshdisinfectantappliedregularly拖把頭應(yīng)定期沖洗和更新消毒液WHY?清潔模塊CLEANINGMODULE47MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-對(duì)墻面和窗戶YoushouldNOTbeabletocleanawholelengthofwallwithoneapplicationofdisinfectant你不可能在使用一次消毒液的情況下就將整個(gè)墻面清潔完WHY?清潔模塊CLEANINGMODULE48MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-對(duì)墻面和窗戶TheCleaningprocessisCRITICALtothearea,thepaceshouldbeslowanddeliberate,thesameasnormaloperations清潔程序?qū)崈魠^(qū)來(lái)說(shuō)是非常關(guān)鍵的，清潔速度應(yīng)慢，清潔應(yīng)仔細(xì)，和正常的操作一樣WHY?清潔模塊CLEANINGMODULE49MOPPINGTECHNIQUESFORWALLSANDWINDOWS

擦拭技巧-對(duì)墻面和窗戶ThepurposeofCleaningistoremoveasmanyparticlesorcontaminatesaspossiblefromthearea清潔的目的在于盡可能的將潔凈區(qū)的塵埃粒子和污染物移除Whenyourusharound,yousweatandgenerateparticles.當(dāng)你在潔凈室東奔西跑的時(shí)候，你會(huì)流汗，產(chǎn)生塵埃粒子清潔模塊CLEANINGMODULE50PARTICLEGENERATION

塵埃粒子的產(chǎn)生清潔模塊CLEANINGMODULE51WIPINGSURFACES

擦拭表面Whenwipingtablesorsurfacesuseunidirectionalstrokes

在擦拭桌子或表面時(shí)應(yīng)單向操作Strokesshouldbeslightlyoverlapping擦拭應(yīng)稍微重疊Refoldwipeaftereachpass–sosurf