滅菌驗證注意事項 中英文對照譯文全套

滅菌驗證注意事項中英文對照譯文Consideration1Choosingtherightsterilisationcycletoimplement注意事項1：選擇正確的滅菌周期Therearethreebasictypesofsterilisationcycles.Choosetherightoneaccordingtothetypeofgoodstobesterilised:有三種基本類型的滅菌周期。根據(jù)待滅菌物質(zhì)的類型進(jìn)行選擇。HardGoods(Vacuum)堅硬裝載（真空）Suitableforitemsthatareeasytosterilise,becauseairremovalandsteampenetrationarehighlyeffectiveontheseitems.e.g.,openglasswareandlargediameterpiping適用于那些易于滅菌的物質(zhì)，因為空氣清除和蒸汽穿透對這些物質(zhì)是高度有效的。例如：敞開的玻璃器皿和大口徑的管道Atypicalhardgoodscyclemaydrawonevacuumpriortointroducingsteamtoreachthedesiredsterilisationtemperature.典型的堅硬物品滅菌循環(huán)在通入蒸汽達(dá)到設(shè)定滅菌溫度前需要達(dá)到一個真空度。WrappedGoods(Vacuum)包裹物品（真空）Utilizedforitemsthataredifficulttosterilise,becauseairremovalandsteampenetrationarehardertoachieveontheseitemsthanonhardgoods.用于滅菌困難的物品，因為和堅硬品比起來空氣清除和蒸汽穿透更難實現(xiàn)。e.g.,emptybottles(glassorplastic)withlids,gowns,longhoses/tubes,ventfilters,portablevesselswithsmallinlet/outletports例如，有蓋子的空瓶（玻璃或塑料），潔凈服，長軟管/管子，抽氣過濾器，進(jìn)/出口小的便攜式容器。Atypicalwrappedgoodscyclemaydrawthreeormorevacuumspriortoreachingsterilisation.Apost-sterilisationvacuumdrawsthesteamfromtheloaditems.一個典型的包裹品滅菌循環(huán)在滅菌前至少進(jìn)行3次抽真空。滅菌后通過真空將負(fù)載中的蒸汽抽走。Liquids(Non-vacuum)液體（非真空）Itemsthatcontainliquidsgenerallycannothaveadeepvacuumpulledortheliquidwillbedrawnoutofthem.Autoclavecyclesforliquidsgenerallyheatupandcooldownwithoutavacuum.Steam,introducedintothetopofthechamber,displacestheair.Theairispushedtothebottomofthechamberandisremoved.一般含有液體的物品不能有大的真空度，否則液體會溢出。針對液體來說高壓滅菌鍋循環(huán)是在沒有真空度的情況下加熱和冷卻。蒸汽進(jìn)入腔室頂部置換空氣，空氣推入腔室的底部并排出。Thestepsinvolvedinchoosingtherightsterilisationcycle.選擇正確滅菌循環(huán)的步驟：Consideration2Whichloadconfigurationstouse?注意事項2：使用那一種負(fù)載配置Avariabletoconsideriswhethertousefixedloadorvariableloadconfigurations.There’satrade-offherebetweenvalidationeffortandoperationalflexibility–doyouwanttovalidateawiderangeofloadconfigurationstoincreaseProduction’sflexibilityinloadingtheautoclave?Herearesometypicalloadconfigurationstoconsider:需要考慮的一個因素是選擇固定裝載還是可變的裝載。在驗證和操作靈活性之間需要一個權(quán)衡-你是否驗證最大最小裝載以增加生產(chǎn)的靈活性？下面是需要考慮的一些典型裝載模式：Afixedload/fixedpositionconfigurationmeansthatanyloadtobesterilisedwillbeplacedinsidethechamberinexactlythesamewayforeveryprocessingrun.AdiagramoftheloadconfigurationshouldappearintheStandardOperatingProcedure(SOP)sothatoperatorscanreproducetheloadforeveryprocessingrun.Thissituationrequiresthefewestvalidationruns(3),butoffersnoflexibilityinloadconfigurations.固定裝載/固定位置模式意味著,任何待滅菌裝載將以完全相同的方式放置在室內(nèi)。在標(biāo)準(zhǔn)作業(yè)流程（SOP）中應(yīng)有負(fù)載配置的圖表，因此操作者可以在腦海中再現(xiàn)每一個運行過程的負(fù)載。這種情況要求最少的驗證運行（3），但負(fù)載配置沒有靈活性。Afixedload/variablepositionconfigurationmeansthatthelocationoftheloaditemsintheautoclavecanvary.OnlyalistoftheitemsthatcanbeinaloadisrequiredfortheSOP.Thevalidationrunsmustdemonstratepositionalequivalencebyrotatingtheitemsfromlocationtolocationduringthetestruns.Ifpositionalequivalenceisprovenafterthreevalidationruns,thenyoucanstop.Afixedload/variablepositionconfigurationgivesoperatorsflexibilityinloadingtheautoclave.Thissavestimewhenloadinglargeloadsofnumerousitemsofdifferenttypes.固定負(fù)載/可變位置模式指負(fù)載在高壓滅菌器內(nèi)的位置是可變的。在SOP中只需一個負(fù)載列表。在測試運行過程中，驗證運行應(yīng)通過輪換負(fù)荷物品逐個位置論證不同位置的等效性。如果經(jīng)過3個run的驗證證明了位置的等效性那就可以停止。固定負(fù)載/可變位置的模式給操作者操作高壓滅菌器時帶來靈活性。針對包含不同物品的大負(fù)載來說，這樣可以節(jié)省時間。Avariableloadconfigurationmeansthatdifferentcombinationsofitemsand/ornumbersofanyitem(s)canbeplacedintothechamber.Thevalidationrunsmustdemonstratethatthecycleisadequateforbothamaximumandminimumloadconfiguration.Theminimumloadtestsaredonewithonlyoneitemintheautoclave,thatitembeingtheloaditemdemonstratedasbeingthemostdifficulttosterilise.可變負(fù)載配置指腔室內(nèi)物品種類和/或數(shù)量不固定。驗證運行時必須表明此循環(huán)周期可以滿足最大和最小兩個負(fù)載模式。最小負(fù)載測試高壓滅菌器腔室一個物品，必須證明其是最難滅菌的一個物品。Consideration3ChoosingtherightControlforliquidcycles注意事項3：選擇合適的液體循環(huán)監(jiān)控裝置ThechoiceoftheControlusedwhensterilisingliquidsdetermineswhethertheloadyouaresterilisingwillpassalltheacceptancecriteria.液體滅菌時所選的監(jiān)控決定了待滅菌的負(fù)載能否通過接收標(biāo)準(zhǔn)。MorethanoneliquidControlmaybeneededtovalidateallthedifferenttypesofbottlesandliquidsrequiringsterilisation.ConsiderthefollowingwhenchoosingtheControlforliquidcycles:需要不止一個液體監(jiān)控裝置以證明不同類型的瓶子和液體能滿足滅菌要求。選擇液體循環(huán)監(jiān)控裝置時需考慮以下因素：Thesizeofthebottleanditsfillvolume–thelargerthebottleandthegreateritsvolume,theharderitistosterilise.瓶子的大小和填充量-瓶子越大其體積越大，就越難滅菌。Thethicknessoftheglass–thickerglassismoredifficulttosterilisethanthinnerglass.玻璃的厚度，厚玻璃比薄玻璃難滅菌Theviscosityoftheliquid–thegreatertheviscosity,theslowertheheat-uptime,andtheharderitistosterilise.液體的粘度–粘度越大傳熱越慢，就越難滅菌。TheliquidControlwillideallybetheonethatisthemostdifficulttosterilise(worst-case)andwillbelocatedatthecoldestspotinthechamber(lowerlevelnearthefrontdoorordirectlyabovethedrain).理想情況下，液體監(jiān)控裝置所在應(yīng)是最難滅菌的（最壞情況），放置在腔室內(nèi)最冷點（靠近前門或在排水口正上方）。Don’tbetemptedtouseaControlthatisdramaticallydifferentfromthecompositionoftheload.IftheliquidControltakestoolongtoreachthesterilisationtemperature,thentheproteincompositionofthemediaintherestoftheload(whichmayhaveexceededthedesiredtemperaturebythetimetheControlreachesthesterilisationtemperature)maybedenatured.不要試圖使用與待滅菌裝載完全不通過的液體監(jiān)控裝置，如果液體控制需要很長時間來達(dá)到滅菌溫度，則負(fù)載其他位置中的蛋白質(zhì)可能會變性（在監(jiān)控裝置到達(dá)滅菌溫度的過程中，可能已經(jīng)超出所要求的溫度）。Ifindoubt,performpreliminarystudiesusingdifferentliquidControlstoobtaininformationontheload'sheat-uptimesandF0-values.不要對不同組分的負(fù)載嘗試控制，如果液體控制需要很長時間還達(dá)不到滅菌溫度，則負(fù)載介質(zhì)中的蛋白質(zhì)將會變性（這可能已經(jīng)超出了控制的時候達(dá)到殺菌所需的溫度）。Thenumberofvalidationrunsrequiredfordifferenttypesofliquidsandbottlescanbereducedbygroupingliquidswithsimilarviscosities,bottlesizesandfillvolumes.EachliquidControlwillhaveauniquemaximumandminimumloadconfigurationassociatedwithit.可以根據(jù)相似粘度，瓶子大小和填充量大小進(jìn)行分組，減少不同類型的液體和瓶子所需驗證測試的次數(shù)。每個液體控制將有一個與之相關(guān)的最大和最小負(fù)載配置。Useproceduralcontrolstoensurethatthechoiceofliquid,bottlesizeandfillvolumeusedforeachControl,anditslocationinthechamber,aremaintainedduringthevalidationrunsandsubsequentprocessingruns.使用程序化的控制，以確保每個液體控制所使用的液體、瓶子體積、填充量，及其在腔室內(nèi)的位置，在驗證期間和后續(xù)操作過程中保持一致。Consideration4Determiningwhichloaditemsarethemostdifficulttosteriliseandwhichlocation(s)withintheitemsrepresentstheworst-caseconditions注意事項4：確定哪些裝載物品是最難滅菌的和哪些位置最能代表滅菌的最差情況Withalargeloadcontainingawidevarietyofdifferenttypesofitems,thenumberofpossibletestlocationswithinitemsseemstoapproachinfinity.Italsocanbedifficulttogetthethermocoupleandindicators(BI&CI)intotheitemwithoutaffectingtheitem’sabilitytobesterilisedand/orruiningtheitem(aconcernwithexpensiveitems).由于負(fù)載包含很多不同類型物品，需要檢測的位置似乎很多。在不影響物品滅菌能力或破壞物品（關(guān)注貴重物品）的情況下，將熱電偶和指示劑（BI與CI）放入物品中也是非常困難的。Wemustevaluateeachitemonacase-by-casebasisanddeterminehowtobestchallengetheitem.Oftentheitemmustbesealedsomehowtoreturnittoastatethatrepresentsequivalencywithrespecttosteampenetration.我們必須逐個逐個評估每個物品，確定最佳挑戰(zhàn)方式。通常,物品必須以某種方式密封,以確保其蒸汽滲透狀態(tài)不變。Someexamples:舉例：Q.Whatisthemostdifficultpointtosteriliseinahoseofuniformdiameter?問：一個直徑均一的軟管內(nèi)哪一點最難滅菌？A.Inthecentreofthelengthofhose.答：在軟管長度的中心。Q.Howdoyougeta3mlengthofthermocoupleintothemiddleofa20mhose?問：如何將一個3米長的熱電偶插入20米的軟管中間？A.Bycuttingaslotinthemiddleofthehoseandinsertingthethermocouplethroughtheslot,makingsuretosealtheslotwithsilicon.Ifyoudon’tsealit,youwillnotbechallengingthehoseproperly.Alternatively,gettwo10mlengthsofhose(ifavailable)andjointhemwithaconnector,afterinsertingthethermocouplethroughtheconnector.Usingthismethoddoesn’truina20mlengthofhose.答：在軟管中間刻一插槽，熱電偶沿著插槽插入軟管，確保用硅膠將插槽密封，如果你沒有密封，則不能挑戰(zhàn)軟管。或者，將兩個10米的軟管（如有）插入熱電偶后用連接器將其連接，用這種方法則不用破壞20米長的管子。Q.Whatistheworst-caselocationwithinabottle,flaskorcylinder?問：瓶子、錐形瓶和柱形瓶那個位置最難滅菌？A.Inthecentrenearthebottom(butnottouchingthefloor).答：在靠近底部的中間（但不接觸底面）。Q.Howdoyouholdathermocoupleinpositioninsideasealedbottle?問：如何保持熱電偶在一個密封瓶子里的位置？A.ChooseapieceofSilastictubingwithaninternaldiameter(ID)thatisnarrowenoughtoholdthethermocoupleprobewithoutlettingitslipthrough.Drillaholeinthebottle'slidthesamesizeastheouterdiameter(OD)ofthetubing.Pushthetubingthroughthehole,intothebottle.Nowpushtheprobeintothetubing.Slidetheprobethroughthetubinguntilitreachesthedesiredpositioninthebottle.Makesureitisnottouchingthewallofthebottle.Forbottleswithrubberstoppers,makeasmallholeinthecentreofthestopper,sufficienttopushthethermocouplethrough.答：選擇一個內(nèi)徑與熱電偶探頭相近的硅橡膠管件套住它以確保不會滑落。在瓶蓋上鉆一個和管子外徑一樣大的孔。通過孔將管子插入瓶中。將探頭推入管子中，推動探頭直至到達(dá)瓶子中所需位置。確保它不會觸碰瓶壁。對于橡膠瓶塞的瓶子，在篩子中間鉆一個小孔，足以使熱電偶通過。Consideration5Wiredtemperaturethermocouplesarecumbersomeanddon’talwaysgiveaccuratedata注意事項5：有線熱電偶較復(fù)雜，且并非總是提供準(zhǔn)確的數(shù)據(jù)Thelistbelowhighlightssomeconsiderationswhenusingwiredthermocouples:下面重點介紹一些使用熱電偶傳感器時的注意事項：Somelossofsteam(leakage)willoccurwhenthewire'souterplasticprotectorhasbeencutandairorsteamcanpassthroughit.Thismayresultinafailedleaktest.當(dāng)導(dǎo)線的外層塑料保護(hù)膜被切割并且有空氣或蒸汽通過，就會發(fā)生一些蒸汽損耗（泄漏），可能會導(dǎo)致泄漏測試失敗。Validatorthermocouplesinsidethechamberwilldrawcondensateandwillneedaslice/cutmadeintheirouterprotectivelayer,toensurethatanyfluidisreleased.Ifcondensatepassesthroughthewiresandintotheelectronics,thethermocoupleswillbedestroyed.在腔室內(nèi)的熱電偶會吸冷凝水，需要在腔室外部將熱電偶保護(hù)層切開以將冷凝水釋放。如冷凝水通過熱電偶流到驗證儀電子元件，熱電偶將損壞。Thethermocouplemaybedifficulttoplaceintotheitemwithoutadverselyaffectingtheitem’sabilitytobesterilisedand/orruiningtheitem(aconcernwithexpensiveitems).熱電偶可能難以在不影響物品滅菌和/或破壞物品(貴重物品)的情況下，放入物品中。Wirescangetcaught(andbedamaged)undertheautoclave'swheelswhenmovingloadsintoandoutofthechamber.當(dāng)進(jìn)料或出料時熱電偶可能被高壓滅菌器的輪子卡住（并損壞）Itisdifficulttoplacewiresinsidesealedbottleswithout(i)touchingtheinsidewall,and(ii)compromisingthebottle’sabilitytobesterilised.將熱電偶裝在密封瓶里并且不碰到內(nèi)壁是很難做到的，并且降低瓶子的無菌程度。Youmaybelimitedbythenumberofwiresyoucanplacethroughtheautoclave'sinlet.你可能會受限于高溫滅菌器進(jìn)口的導(dǎo)線數(shù)量。Theresistanceofthethermocoupleinsomelocationsinthechambercanchange,leadingtoinaccurateand/orunreliabledataeventhoughthepre/postcalibrationverificationsmeetspecifications.即使前/后校準(zhǔn)確認(rèn)符合標(biāo)準(zhǔn)，某些位置熱電偶電阻也會發(fā)生變化，從而導(dǎo)致數(shù)據(jù)不準(zhǔn)確和/或不可靠。CaseStudy示例Thisexamplelooksatninethermocouplesplacedintoaloadedchamber.Theywereevenlyspacedfromoneanotheratthetop,middleandbottomlevelsandatthefront,centreandrearofthechamber.此示例包含裝載腔室內(nèi)的9個熱電偶。他們均勻分布在頂部，中部和底部，以及前、中、后部。Thestudyusedwiredthermocouplesinaloadedchamberfora40-minutecycleat121.1°C.Thechamber'smaximumpressureof2.16bar(atanytime)wasequivalentto122.7°C.Oneprobe(topfrontLHS)constantlyreachedtemperaturesbetween123.3°Cand123.5°C.Allotherprobeswerewithintherequiredlimitof120.1°C+2°C/-1°Cattemperaturesfrom122.4°Cto122.7°C.該研究使用有線熱電偶用于測試121.1℃40分鐘的負(fù)載腔體。內(nèi)室最大壓力2.16bar（在任何時間）相當(dāng)于122.7℃。一個探頭（頂部前左）溫度持續(xù)維持在123.3°C-123.5°C之間。所有其他探頭則在規(guī)定溫度范圍120.1℃+2°C/-1°C內(nèi)，在122.4°C至122.7°C之間Thetemperaturedifferentialstartedduringheat-upandremainedduringthesterilisationandpostvacuumcoolingphases.TheEquipmentEngineerandtheManufactureragreedthatthetemperaturereadingatthispositionwasinaccurateandunreliable.Thethermocouplereadingwasinconsistentwiththesteampressureindicationandtheotherthermocouplereadings.Consequently,nousefuldatawerecollectedatthatpoint.溫度偏差開始于加熱階段，并在滅菌和真空冷卻階段仍然存在。該設(shè)備工程師和制造商一致認(rèn)為，在這個點的溫度讀數(shù)是不準(zhǔn)確和不可靠的。熱電偶讀數(shù)與蒸汽壓力讀數(shù)以及其他熱電偶讀數(shù)不一致。因此，在這一點沒有任何有用的數(shù)據(jù)。Consideration6Determiningtheacceptancecriteria注意事項6：確定接受標(biāo)準(zhǔn)Anexample:一個例子：Yourunyourvalidationstudies,onlytorealisethatyoucannotmeetoneoftheacceptancecriteria.But,wasitreallyneededinthefirstplace?當(dāng)您運行驗證測試時，您只認(rèn)識到能不能達(dá)到接受標(biāo)準(zhǔn)。但是，是不是真的需要擺在首位？It’simportanttounderstandtheaimoftheautoclavecycleandwhatitsparametersare.Forexample,isitforsterilisationordecontamination?Istheloadheatsensitive,orcanitbesubjectedtoanoverkillcycle?Isitaporousload(hard/wrappedgoods),orisitaliquid?重要的是要了解滅菌柜的周期及其參數(shù)。例如，是用于滅菌還是降低負(fù)荷？負(fù)載是熱敏感的嗎？還是可以承受過度滅菌？是多孔裝載（堅硬/包裹的物品）嗎？，還是液體？MostValidationdepartmentshaveaStandardOperatingProcedure(SOP)detailingthevalidationrequirementsforsterilisationprocesses.Includedinthatisacompletelistofalltheacceptancecriteria.大多數(shù)驗證部門有標(biāo)準(zhǔn)操作程序（SOP）詳細(xì)說明滅菌工藝驗證的要求。列出所有接受標(biāo)準(zhǔn)的完整清單。Eachphaseoftheautoclavecycleislikelytohavedifferentacceptancecriteria:滅菌柜不同階段的循環(huán)周期存在不同的遵循標(biāo)準(zhǔn)：PhaseI–Heatdistribution(emptychamber)第一階段-熱分布（空載）PhaseII–Heatdistribution(loaded)第二階段-熱分布（裝載）PhaseIII–Heatdistribution(loaded)coldspotdeterminationwithin第三階段-熱分布（裝載）內(nèi)部冷點測定PhaseIV–Heatpenetration第四階段-熱穿透TheremayalsobedifferentrequirementsforPhasesIIIandIVifyouaresterilisingliquids(non-vacuum)vs.porousitems(vacuum),e.g.,F0>15attheendofsterilisation(liquidsonly).對于滅菌液體（非真空）和多孔裝載（真空），第三階段和第四階段可能存在不同的要求，例如滅菌結(jié)束時F0>15（只針對液體）。Typicalacceptancecriteriaareasfollows:典型的接受標(biāo)準(zhǔn)如下：AllporouscyclesrequireminSAL10-6attheendofsterilisation.Allporousitemsaresubjecttoatleastonepost-vacuumcyclewhichremovessteamfromthechamber(PhasesIII&IV).所有多孔裝載程序要求結(jié)束時SAL≤10-6。所有多孔物品至少進(jìn)行一次后真空循環(huán)以消除滅菌腔室內(nèi)的蒸汽（階段三和四）。AllliquidcyclesrequireaminSAL10-6andaminF0>15attheendofthecycle,becausetheydonotusevacuumandaresubjecttonaturalcooling(PhasesIII&IV).所有液體循環(huán)周期要求SAL≤10-6，并且F0>15，因為它們不使用真空，并自然冷卻（階段三和四）。Throughoutthesterilisationphasealltemperaturesarewithina3°Crange(PhasesII,III&IV),e.g.,121.1°C-1°C/+2°C.在整個滅菌階段所有的溫度都在3°C的變化范圍內(nèi)（階段二，三和四）例如，121.1°C-1℃/+2°CThroughoutthesterilisationphasealltemperaturesinthechamberarewithin1.0°Cofthechamber'smeantemperature(PhaseII).在整個滅菌階段，滅菌柜各探頭溫度在平均溫度±1.0℃范圍內(nèi)，（階段二）。Thesteam'stemperaturecorrespondstoitsvapourpressure(PhasesII,III&IV).4蒸汽的溫度與其蒸氣壓力相適應(yīng)（階段II，III及IV）。Timedmeasurementsaretobecontrolledtoanaccuracyof±1%.時間計時控制在±1%的精度范圍內(nèi)（階段II，III及IV）。Requiredpre-certificationandpost-certificationofthedataloggerensuresthatthetemperaturemeasurementsystemisaccuratetowithin±0.5°C.驗證前和驗證后溫度測量系統(tǒng)的準(zhǔn)確度在±0.5℃的范圍內(nèi)。Theloadisvisuallydryattheendofthecycle(porouscyclesonly).滅菌結(jié)束時裝載目測干燥（只針對多孔裝載）。AllautoclavedBiologicalIndicators(BIs)arenegativeandthecontrolispositivefollowingincubation(PhaseIV).所有生物指示劑培養(yǎng)結(jié)果陰性，陽性對照陽性（階段IV）。Consideration7Adequatelydocumentingthevalidationtestruns注意事項7：充分記錄驗證測試Documentingwhatwasdoneduringthevalidationtestrunsisallaboutknowingwhatneedstobedocumentedandhowtopresentit.Thisdocumentationmustbeclear,consistentbetweenrunsandtransparent,andmustconformtoallGMPrequirements.Itmustbecompleteandmustincludethefollowingitems:記錄驗證測試期間進(jìn)行的工作,就是了解需要記錄的內(nèi)容以及如何記錄它。記錄清晰、一致和一目了然,并且必須符合所有GMP要求。它必須是完整的,并且必須包括以下項目:adiagramshowingthelocationofallloaditemswithintheautoclavechamber顯示高壓滅菌腔室內(nèi)所有裝載物品位置的圖表thepreciselocation/numberofeachthermocouple,BIandCIwithineachitem各熱電偶、BI、CI的數(shù)目和精確位置theprintoutfromthedatarecorder數(shù)據(jù)記錄器（熱電偶）打印輸出theprintoutorchartfromtheautoclave從滅菌器打印或輸出圖表thetimethesterilisationperiodbeganandfinished(perthedatarecordertime)滅菌周期起始和結(jié)束（根據(jù)數(shù)據(jù)記錄器的時間）thetimedifferencebetweentheautoclavecontrollerandthevalidationtemperaturemonitoringdevice高壓滅菌柜控制器和溫度驗證儀的時間差theresultsofeachBIandCI各生物指示劑和化學(xué)指示劑的結(jié)果LabeleachdocumentwiththeequipmentID,loaddescription,date,testrunnumberandcyclestart/endtime.每個記錄分別標(biāo)明設(shè)備ID、負(fù)載說明、日期、測試編號和循環(huán)開始/結(jié)束時間。Ifyoufailtogenerategooddocumentationwhileconductingthevalidationtestruns,youwillnotbeabletoanalysethedatawhenputtingtogetherthereport.Inadequateorpoorqualitydatatosupportthevalidationprocesswillnotsurvivethescrutinyofanauditor.當(dāng)進(jìn)行驗證測試過程中，如果你沒有良好記錄，在報告時，你將無法進(jìn)行數(shù)據(jù)分析。用不充分或不良的數(shù)據(jù)來支持驗證過程將無法通過審計。Tip:提示Becautiousabouttheacceptancecriteriayouemploytoverifytheaccuracyofthermocouples.Ifthecriterionistootight(e.g.,allthermocouplesmustmeettheacceptancecriteria),youmaylosealotofrunsifoneortwothermocouplesceasefunctioningorareoutsidethetemperaturetoleranceaftertheruns.注意謹(jǐn)慎使用熱電偶的精確度接受標(biāo)準(zhǔn)，如果標(biāo)準(zhǔn)過高（如所有的熱電偶必須達(dá)到接受標(biāo)準(zhǔn)），如有一或兩個熱電偶停止工作或在測試后超出溫度容許偏差，則可能會丟失大量運行。Consideration8Thefrequencyofthermocoupleaccuracyverification注意事項8：熱電偶準(zhǔn)確度確認(rèn)的頻率Ifyouareperformingalargenumberoftestruns(e.g.,overthecourseofseveralweeks),youneedtothinkaboutthepointsatwhichyouwillverifythethermocouples'accuracy.Thiscouldbedoneaftereveryrunand/orattheendoftheentiretestingperiod.Ifyouwaituntiltheendofthetestingperiod,youruntheriskthatalloftherunsareofnovalueduetotheirfailuretomeettheverificationacceptancecriteria.Verifyingaftereveryrun,however,addsconsiderablytothelengthoftimerequiredtocompletethetesting.Performingtheverificationeverythreerunsoreveryfewdaysisareasonablecompromise.如果你正在進(jìn)行（如，在幾個星期內(nèi)）大量的驗證測試，你需要考慮熱電偶的準(zhǔn)確度。可以在每次運行和/或在整個測試周期結(jié)束后進(jìn)行。如果等到測試周期結(jié)束,則存在由于熱電偶未滿足接受驗收標(biāo)準(zhǔn)而導(dǎo)致所有測試失效的風(fēng)險。但是，在每次測試后做檢查，則會大大增加完成測試所需的時間。每三次運行或每隔幾天執(zhí)行一次準(zhǔn)確性檢查是一種合理的折衷方案。AsnotedinConsideration6,theacceptancecriterionyouemploytoverifythethermocouples'accuracyshouldallowatleastoneortwothermocouplestofail.正如注意事項6指出，驗證熱電偶的準(zhǔn)確度，應(yīng)允許至少一個或兩個熱電偶失效。Consideration9Havingadequatetimeandaccesstotheautoclavetocompletethevalidation注意事項9：確保足夠的時間和支配來完成驗證It’seasytounderestimatethelengthoftimeittakestovalidateanautoclave,andhowmuchaccessyouneedtoitduringtheprocess.人們很容易低估驗證高溫滅菌器所需的時間，以及在整個驗證過程中你需要做些什么。Forexample,itcantakeuptofourhourstosetupyourrun,i.e.,preparetheload,placeprobes,BIsandCIsintotheload,etc.IfProductionneedstousetheautoclaveandyouneedtoremoveyourprobes,BIsandCIs,thenyouneedtostartalloveragain,effectivelylosingaday.WorkwiththeProductiondepartmentwhenplanningtheValidationprojecttoensurethatyouhaveadequateaccesstotheautoclave.例如，可能需要長達(dá)四個小時進(jìn)行準(zhǔn)備，例如，準(zhǔn)備裝載，放置探頭，將BI和CI放入負(fù)載中等。如果生產(chǎn)需要使用高壓滅菌器，你需要將探頭，BI和CI挪出來，然后從頭再來，白白浪費一天。在規(guī)劃驗證項目時與生產(chǎn)部門合作，以確保你能有足夠的支配。AnotherapproachistocombinePhaseIIandIII(HeatDistribution)withPhaseIV(HeatPenetration)studiestosavetime.另一種方法是將階段II、階段III（熱分布）與階段IV（熱滲透）結(jié)合在一起，以節(jié)省時間。Combiningthesethreephasescouldreducethetimeittakestocompletethevalidationproject;however,youneedtoconsiderthefollowingwhendoingthis:這三個階段結(jié)合一起做可以減少完成驗證的時間，不過，這樣做需要考慮以下幾點：1Youwillneedtoplaceprobesintothechamberandintoloaditemsatthesametime.Canyoufitalltheprobesthroughtheautoclave'sinlet?Ifnot,thenyouneedtoeithervalidateeachphaseseparately,orreducethenumberofprobes.1、需要同時將探頭放入墻體內(nèi)和負(fù)載物上。通過高壓滅菌器驗證口你能安裝所有的探頭嗎？如果不能，那么你需要單獨驗證每個階段，或降低探頭的數(shù)量。2Combiningthesethreephasesgreatlyincreasesyourpreparationtime.Ifyouareworkingonatightschedule(e.g.,onaconstructionsitewhereyouneedtoevacuateatacertaintime),youmaynothavetimetocompletethestudy.Ifthishappens,thenitmaytakemoretimetoperformtheworkthanifyouhaddoneeachphaseseparately.2、這三個階段結(jié)合在一起做會大大增加你的準(zhǔn)備時間。如果你的時間較緊(例如，在需要在特定時間撤離的建筑工地上),，你可能沒有時間完成這項分析。如果發(fā)生這種情況，那么它需要完成的時間比單獨做每個階段的時間要長。3Ifyouareundertimepressure,thereisagreaterchancethatyouwillmisssomethingormakeamistake.3、如果你的時間很緊，將很容易遺忘一些東西或者犯錯誤。4Therearemoredatatoconsider.Ifyoucheckonlyafewcriticalrequirementsbeforeproceedingtothenextstudy,youmaymisssomethingthatdidnotmeetanacceptancecriterion.Thismaymeanthatallsubsequentstudiesareatrisk,becausethedatacannotbeverified.Forexample,aprobemaybefalselyreadingtoohigh.4、還有更多的數(shù)據(jù)需要考慮。進(jìn)行下一個研究前，如果你只檢查了幾個關(guān)鍵點，您可能會疏忽一些不符合驗證標(biāo)準(zhǔn)的內(nèi)容，這可能意味著所有后續(xù)的研究處于風(fēng)險之中，因為數(shù)據(jù)無法得到證實。例如，一個探頭讀數(shù)可能過高。5Allowenoughtimeforthereporttobecompleted.5、準(zhǔn)備充足的時間來完成報告。Ifyouarevalidatinganewautoclave,thenyouneedtoallowenou