灭菌验证注意事项 中英文对照译文全套

灭菌验证注意事项中英文对照译文Consideration1Choosingtherightsterilisationcycletoimplement注意事项1：选择正确的灭菌周期Therearethreebasictypesofsterilisationcycles.Choosetherightoneaccordingtothetypeofgoodstobesterilised:有三种基本类型的灭菌周期。根据待灭菌物质的类型进行选择。HardGoods(Vacuum)坚硬装载（真空）Suitableforitemsthatareeasytosterilise,becauseairremovalandsteampenetrationarehighlyeffectiveontheseitems.e.g.,openglasswareandlargediameterpiping适用于那些易于灭菌的物质，因为空气清除和蒸汽穿透对这些物质是高度有效的。例如：敞开的玻璃器皿和大口径的管道Atypicalhardgoodscyclemaydrawonevacuumpriortointroducingsteamtoreachthedesiredsterilisationtemperature.典型的坚硬物品灭菌循环在通入蒸汽达到设定灭菌温度前需要达到一个真空度。WrappedGoods(Vacuum)包裹物品（真空）Utilizedforitemsthataredifficulttosterilise,becauseairremovalandsteampenetrationarehardertoachieveontheseitemsthanonhardgoods.用于灭菌困难的物品，因为和坚硬品比起来空气清除和蒸汽穿透更难实现。e.g.,emptybottles(glassorplastic)withlids,gowns,longhoses/tubes,ventfilters,portablevesselswithsmallinlet/outletports例如，有盖子的空瓶（玻璃或塑料），洁净服，长软管/管子，抽气过滤器，进/出口小的便携式容器。Atypicalwrappedgoodscyclemaydrawthreeormorevacuumspriortoreachingsterilisation.Apost-sterilisationvacuumdrawsthesteamfromtheloaditems.一个典型的包裹品灭菌循环在灭菌前至少进行3次抽真空。灭菌后通过真空将负载中的蒸汽抽走。Liquids(Non-vacuum)液体（非真空）Itemsthatcontainliquidsgenerallycannothaveadeepvacuumpulledortheliquidwillbedrawnoutofthem.Autoclavecyclesforliquidsgenerallyheatupandcooldownwithoutavacuum.Steam,introducedintothetopofthechamber,displacestheair.Theairispushedtothebottomofthechamberandisremoved.一般含有液体的物品不能有大的真空度，否则液体会溢出。针对液体来说高压灭菌锅循环是在没有真空度的情况下加热和冷却。蒸汽进入腔室顶部置换空气，空气推入腔室的底部并排出。Thestepsinvolvedinchoosingtherightsterilisationcycle.选择正确灭菌循环的步骤：Consideration2Whichloadconfigurationstouse?注意事项2：使用那一种负载配置Avariabletoconsideriswhethertousefixedloadorvariableloadconfigurations.There’satrade-offherebetweenvalidationeffortandoperationalflexibility–doyouwanttovalidateawiderangeofloadconfigurationstoincreaseProduction’sflexibilityinloadingtheautoclave?Herearesometypicalloadconfigurationstoconsider:需要考虑的一个因素是选择固定装载还是可变的装载。在验证和操作灵活性之间需要一个权衡-你是否验证最大最小装载以增加生产的灵活性？下面是需要考虑的一些典型装载模式：Afixedload/fixedpositionconfigurationmeansthatanyloadtobesterilisedwillbeplacedinsidethechamberinexactlythesamewayforeveryprocessingrun.AdiagramoftheloadconfigurationshouldappearintheStandardOperatingProcedure(SOP)sothatoperatorscanreproducetheloadforeveryprocessingrun.Thissituationrequiresthefewestvalidationruns(3),butoffersnoflexibilityinloadconfigurations.固定装载/固定位置模式意味着,任何待灭菌装载将以完全相同的方式放置在室内。在标准作业流程（SOP）中应有负载配置的图表，因此操作者可以在脑海中再现每一个运行过程的负载。这种情况要求最少的验证运行（3），但负载配置没有灵活性。Afixedload/variablepositionconfigurationmeansthatthelocationoftheloaditemsintheautoclavecanvary.OnlyalistoftheitemsthatcanbeinaloadisrequiredfortheSOP.Thevalidationrunsmustdemonstratepositionalequivalencebyrotatingtheitemsfromlocationtolocationduringthetestruns.Ifpositionalequivalenceisprovenafterthreevalidationruns,thenyoucanstop.Afixedload/variablepositionconfigurationgivesoperatorsflexibilityinloadingtheautoclave.Thissavestimewhenloadinglargeloadsofnumerousitemsofdifferenttypes.固定负载/可变位置模式指负载在高压灭菌器内的位置是可变的。在SOP中只需一个负载列表。在测试运行过程中，验证运行应通过轮换负荷物品逐个位置论证不同位置的等效性。如果经过3个run的验证证明了位置的等效性那就可以停止。固定负载/可变位置的模式给操作者操作高压灭菌器时带来灵活性。针对包含不同物品的大负载来说，这样可以节省时间。Avariableloadconfigurationmeansthatdifferentcombinationsofitemsand/ornumbersofanyitem(s)canbeplacedintothechamber.Thevalidationrunsmustdemonstratethatthecycleisadequateforbothamaximumandminimumloadconfiguration.Theminimumloadtestsaredonewithonlyoneitemintheautoclave,thatitembeingtheloaditemdemonstratedasbeingthemostdifficulttosterilise.可变负载配置指腔室内物品种类和/或数量不固定。验证运行时必须表明此循环周期可以满足最大和最小两个负载模式。最小负载测试高压灭菌器腔室一个物品，必须证明其是最难灭菌的一个物品。Consideration3ChoosingtherightControlforliquidcycles注意事项3：选择合适的液体循环监控装置ThechoiceoftheControlusedwhensterilisingliquidsdetermineswhethertheloadyouaresterilisingwillpassalltheacceptancecriteria.液体灭菌时所选的监控决定了待灭菌的负载能否通过接收标准。MorethanoneliquidControlmaybeneededtovalidateallthedifferenttypesofbottlesandliquidsrequiringsterilisation.ConsiderthefollowingwhenchoosingtheControlforliquidcycles:需要不止一个液体监控装置以证明不同类型的瓶子和液体能满足灭菌要求。选择液体循环监控装置时需考虑以下因素：Thesizeofthebottleanditsfillvolume–thelargerthebottleandthegreateritsvolume,theharderitistosterilise.瓶子的大小和填充量-瓶子越大其体积越大，就越难灭菌。Thethicknessoftheglass–thickerglassismoredifficulttosterilisethanthinnerglass.玻璃的厚度，厚玻璃比薄玻璃难灭菌Theviscosityoftheliquid–thegreatertheviscosity,theslowertheheat-uptime,andtheharderitistosterilise.液体的粘度–粘度越大传热越慢，就越难灭菌。TheliquidControlwillideallybetheonethatisthemostdifficulttosterilise(worst-case)andwillbelocatedatthecoldestspotinthechamber(lowerlevelnearthefrontdoorordirectlyabovethedrain).理想情况下，液体监控装置所在应是最难灭菌的（最坏情况），放置在腔室内最冷点（靠近前门或在排水口正上方）。Don’tbetemptedtouseaControlthatisdramaticallydifferentfromthecompositionoftheload.IftheliquidControltakestoolongtoreachthesterilisationtemperature,thentheproteincompositionofthemediaintherestoftheload(whichmayhaveexceededthedesiredtemperaturebythetimetheControlreachesthesterilisationtemperature)maybedenatured.不要试图使用与待灭菌装载完全不通过的液体监控装置，如果液体控制需要很长时间来达到灭菌温度，则负载其他位置中的蛋白质可能会变性（在监控装置到达灭菌温度的过程中，可能已经超出所要求的温度）。Ifindoubt,performpreliminarystudiesusingdifferentliquidControlstoobtaininformationontheload'sheat-uptimesandF0-values.不要对不同组分的负载尝试控制，如果液体控制需要很长时间还达不到灭菌温度，则负载介质中的蛋白质将会变性（这可能已经超出了控制的时候达到杀菌所需的温度）。Thenumberofvalidationrunsrequiredfordifferenttypesofliquidsandbottlescanbereducedbygroupingliquidswithsimilarviscosities,bottlesizesandfillvolumes.EachliquidControlwillhaveauniquemaximumandminimumloadconfigurationassociatedwithit.可以根据相似粘度，瓶子大小和填充量大小进行分组，减少不同类型的液体和瓶子所需验证测试的次数。每个液体控制将有一个与之相关的最大和最小负载配置。Useproceduralcontrolstoensurethatthechoiceofliquid,bottlesizeandfillvolumeusedforeachControl,anditslocationinthechamber,aremaintainedduringthevalidationrunsandsubsequentprocessingruns.使用程序化的控制，以确保每个液体控制所使用的液体、瓶子体积、填充量，及其在腔室内的位置，在验证期间和后续操作过程中保持一致。Consideration4Determiningwhichloaditemsarethemostdifficulttosteriliseandwhichlocation(s)withintheitemsrepresentstheworst-caseconditions注意事项4：确定哪些装载物品是最难灭菌的和哪些位置最能代表灭菌的最差情况Withalargeloadcontainingawidevarietyofdifferenttypesofitems,thenumberofpossibletestlocationswithinitemsseemstoapproachinfinity.Italsocanbedifficulttogetthethermocoupleandindicators(BI&CI)intotheitemwithoutaffectingtheitem’sabilitytobesterilisedand/orruiningtheitem(aconcernwithexpensiveitems).由于负载包含很多不同类型物品，需要检测的位置似乎很多。在不影响物品灭菌能力或破坏物品（关注贵重物品）的情况下，将热电偶和指示剂（BI与CI）放入物品中也是非常困难的。Wemustevaluateeachitemonacase-by-casebasisanddeterminehowtobestchallengetheitem.Oftentheitemmustbesealedsomehowtoreturnittoastatethatrepresentsequivalencywithrespecttosteampenetration.我们必须逐个逐个评估每个物品，确定最佳挑战方式。通常,物品必须以某种方式密封,以确保其蒸汽渗透状态不变。Someexamples:举例：Q.Whatisthemostdifficultpointtosteriliseinahoseofuniformdiameter?问：一个直径均一的软管内哪一点最难灭菌？A.Inthecentreofthelengthofhose.答：在软管长度的中心。Q.Howdoyougeta3mlengthofthermocoupleintothemiddleofa20mhose?问：如何将一个3米长的热电偶插入20米的软管中间？A.Bycuttingaslotinthemiddleofthehoseandinsertingthethermocouplethroughtheslot,makingsuretosealtheslotwithsilicon.Ifyoudon’tsealit,youwillnotbechallengingthehoseproperly.Alternatively,gettwo10mlengthsofhose(ifavailable)andjointhemwithaconnector,afterinsertingthethermocouplethroughtheconnector.Usingthismethoddoesn’truina20mlengthofhose.答：在软管中间刻一插槽，热电偶沿着插槽插入软管，确保用硅胶将插槽密封，如果你没有密封，则不能挑战软管。或者，将两个10米的软管（如有）插入热电偶后用连接器将其连接，用这种方法则不用破坏20米长的管子。Q.Whatistheworst-caselocationwithinabottle,flaskorcylinder?问：瓶子、锥形瓶和柱形瓶那个位置最难灭菌？A.Inthecentrenearthebottom(butnottouchingthefloor).答：在靠近底部的中间（但不接触底面）。Q.Howdoyouholdathermocoupleinpositioninsideasealedbottle?问：如何保持热电偶在一个密封瓶子里的位置？A.ChooseapieceofSilastictubingwithaninternaldiameter(ID)thatisnarrowenoughtoholdthethermocoupleprobewithoutlettingitslipthrough.Drillaholeinthebottle'slidthesamesizeastheouterdiameter(OD)ofthetubing.Pushthetubingthroughthehole,intothebottle.Nowpushtheprobeintothetubing.Slidetheprobethroughthetubinguntilitreachesthedesiredpositioninthebottle.Makesureitisnottouchingthewallofthebottle.Forbottleswithrubberstoppers,makeasmallholeinthecentreofthestopper,sufficienttopushthethermocouplethrough.答：选择一个内径与热电偶探头相近的硅橡胶管件套住它以确保不会滑落。在瓶盖上钻一个和管子外径一样大的孔。通过孔将管子插入瓶中。将探头推入管子中，推动探头直至到达瓶子中所需位置。确保它不会触碰瓶壁。对于橡胶瓶塞的瓶子，在筛子中间钻一个小孔，足以使热电偶通过。Consideration5Wiredtemperaturethermocouplesarecumbersomeanddon’talwaysgiveaccuratedata注意事项5：有线热电偶较复杂，且并非总是提供准确的数据Thelistbelowhighlightssomeconsiderationswhenusingwiredthermocouples:下面重点介绍一些使用热电偶传感器时的注意事项：Somelossofsteam(leakage)willoccurwhenthewire'souterplasticprotectorhasbeencutandairorsteamcanpassthroughit.Thismayresultinafailedleaktest.当导线的外层塑料保护膜被切割并且有空气或蒸汽通过，就会发生一些蒸汽损耗（泄漏），可能会导致泄漏测试失败。Validatorthermocouplesinsidethechamberwilldrawcondensateandwillneedaslice/cutmadeintheirouterprotectivelayer,toensurethatanyfluidisreleased.Ifcondensatepassesthroughthewiresandintotheelectronics,thethermocoupleswillbedestroyed.在腔室内的热电偶会吸冷凝水，需要在腔室外部将热电偶保护层切开以将冷凝水释放。如冷凝水通过热电偶流到验证仪电子元件，热电偶将损坏。Thethermocouplemaybedifficulttoplaceintotheitemwithoutadverselyaffectingtheitem’sabilitytobesterilisedand/orruiningtheitem(aconcernwithexpensiveitems).热电偶可能难以在不影响物品灭菌和/或破坏物品(贵重物品)的情况下，放入物品中。Wirescangetcaught(andbedamaged)undertheautoclave'swheelswhenmovingloadsintoandoutofthechamber.当进料或出料时热电偶可能被高压灭菌器的轮子卡住（并损坏）Itisdifficulttoplacewiresinsidesealedbottleswithout(i)touchingtheinsidewall,and(ii)compromisingthebottle’sabilitytobesterilised.将热电偶装在密封瓶里并且不碰到内壁是很难做到的，并且降低瓶子的无菌程度。Youmaybelimitedbythenumberofwiresyoucanplacethroughtheautoclave'sinlet.你可能会受限于高温灭菌器进口的导线数量。Theresistanceofthethermocoupleinsomelocationsinthechambercanchange,leadingtoinaccurateand/orunreliabledataeventhoughthepre/postcalibrationverificationsmeetspecifications.即使前/后校准确认符合标准，某些位置热电偶电阻也会发生变化，从而导致数据不准确和/或不可靠。CaseStudy示例Thisexamplelooksatninethermocouplesplacedintoaloadedchamber.Theywereevenlyspacedfromoneanotheratthetop,middleandbottomlevelsandatthefront,centreandrearofthechamber.此示例包含装载腔室内的9个热电偶。他们均匀分布在顶部，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.该研究使用有线热电偶用于测试121.1℃40分钟的负载腔体。内室最大压力2.16bar（在任何时间）相当于122.7℃。一个探头（顶部前左）温度持续维持在123.3°C-123.5°C之间。所有其他探头则在规定温度范围120.1℃+2°C/-1°C内，在122.4°C至122.7°C之间Thetemperaturedifferentialstartedduringheat-upandremainedduringthesterilisationandpostvacuumcoolingphases.TheEquipmentEngineerandtheManufactureragreedthatthetemperaturereadingatthispositionwasinaccurateandunreliable.Thethermocouplereadingwasinconsistentwiththesteampressureindicationandtheotherthermocouplereadings.Consequently,nousefuldatawerecollectedatthatpoint.温度偏差开始于加热阶段，并在灭菌和真空冷却阶段仍然存在。该设备工程师和制造商一致认为，在这个点的温度读数是不准确和不可靠的。热电偶读数与蒸汽压力读数以及其他热电偶读数不一致。因此，在这一点没有任何有用的数据。Consideration6Determiningtheacceptancecriteria注意事项6：确定接受标准Anexample:一个例子：Yourunyourvalidationstudies,onlytorealisethatyoucannotmeetoneoftheacceptancecriteria.But,wasitreallyneededinthefirstplace?当您运行验证测试时，您只认识到能不能达到接受标准。但是，是不是真的需要摆在首位？It’simportanttounderstandtheaimoftheautoclavecycleandwhatitsparametersare.Forexample,isitforsterilisationordecontamination?Istheloadheatsensitive,orcanitbesubjectedtoanoverkillcycle?Isitaporousload(hard/wrappedgoods),orisitaliquid?重要的是要了解灭菌柜的周期及其参数。例如，是用于灭菌还是降低负荷？负载是热敏感的吗？还是可以承受过度灭菌？是多孔装载（坚硬/包裹的物品）吗？，还是液体？MostValidationdepartmentshaveaStandardOperatingProcedure(SOP)detailingthevalidationrequirementsforsterilisationprocesses.Includedinthatisacompletelistofalltheacceptancecriteria.大多数验证部门有标准操作程序（SOP）详细说明灭菌工艺验证的要求。列出所有接受标准的完整清单。Eachphaseoftheautoclavecycleislikelytohavedifferentacceptancecriteria:灭菌柜不同阶段的循环周期存在不同的遵循标准：PhaseI–Heatdistribution(emptychamber)第一阶段-热分布（空载）PhaseII–Heatdistribution(loaded)第二阶段-热分布（装载）PhaseIII–Heatdistribution(loaded)coldspotdeterminationwithin第三阶段-热分布（装载）内部冷点测定PhaseIV–Heatpenetration第四阶段-热穿透TheremayalsobedifferentrequirementsforPhasesIIIandIVifyouaresterilisingliquids(non-vacuum)vs.porousitems(vacuum),e.g.,F0>15attheendofsterilisation(liquidsonly).对于灭菌液体（非真空）和多孔装载（真空），第三阶段和第四阶段可能存在不同的要求，例如灭菌结束时F0>15（只针对液体）。Typicalacceptancecriteriaareasfollows:典型的接受标准如下：AllporouscyclesrequireminSAL10-6attheendofsterilisation.Allporousitemsaresubjecttoatleastonepost-vacuumcyclewhichremovessteamfromthechamber(PhasesIII&IV).所有多孔装载程序要求结束时SAL≤10-6。所有多孔物品至少进行一次后真空循环以消除灭菌腔室内的蒸汽（阶段三和四）。AllliquidcyclesrequireaminSAL10-6andaminF0>15attheendofthecycle,becausetheydonotusevacuumandaresubjecttonaturalcooling(PhasesIII&IV).所有液体循环周期要求SAL≤10-6，并且F0>15，因为它们不使用真空，并自然冷却（阶段三和四）。Throughoutthesterilisationphasealltemperaturesarewithina3°Crange(PhasesII,III&IV),e.g.,121.1°C-1°C/+2°C.在整个灭菌阶段所有的温度都在3°C的变化范围内（阶段二，三和四）例如，121.1°C-1℃/+2°CThroughoutthesterilisationphasealltemperaturesinthechamberarewithin1.0°Cofthechamber'smeantemperature(PhaseII).在整个灭菌阶段，灭菌柜各探头温度在平均温度±1.0℃范围内，（阶段二）。Thesteam'stemperaturecorrespondstoitsvapourpressure(PhasesII,III&IV).4蒸汽的温度与其蒸气压力相适应（阶段II，III及IV）。Timedmeasurementsaretobecontrolledtoanaccuracyof±1%.时间计时控制在±1%的精度范围内（阶段II，III及IV）。Requiredpre-certificationandpost-certificationofthedataloggerensuresthatthetemperaturemeasurementsystemisaccuratetowithin±0.5°C.验证前和验证后温度测量系统的准确度在±0.5℃的范围内。Theloadisvisuallydryattheendofthecycle(porouscyclesonly).灭菌结束时装载目测干燥（只针对多孔装载）。AllautoclavedBiologicalIndicators(BIs)arenegativeandthecontrolispositivefollowingincubation(PhaseIV).所有生物指示剂培养结果阴性，阳性对照阳性（阶段IV）。Consideration7Adequatelydocumentingthevalidationtestruns注意事项7：充分记录验证测试Documentingwhatwasdoneduringthevalidationtestrunsisallaboutknowingwhatneedstobedocumentedandhowtopresentit.Thisdocumentationmustbeclear,consistentbetweenrunsandtransparent,andmustconformtoallGMPrequirements.Itmustbecompleteandmustincludethefollowingitems:记录验证测试期间进行的工作,就是了解需要记录的内容以及如何记录它。记录清晰、一致和一目了然,并且必须符合所有GMP要求。它必须是完整的,并且必须包括以下项目:adiagramshowingthelocationofallloaditemswithintheautoclavechamber显示高压灭菌腔室内所有装载物品位置的图表thepreciselocation/numberofeachthermocouple,BIandCIwithineachitem各热电偶、BI、CI的数目和精确位置theprintoutfromthedatarecorder数据记录器（热电偶）打印输出theprintoutorchartfromtheautoclave从灭菌器打印或输出图表thetimethesterilisationperiodbeganandfinished(perthedatarecordertime)灭菌周期起始和结束（根据数据记录器的时间）thetimedifferencebetweentheautoclavecontrollerandthevalidationtemperaturemonitoringdevice高压灭菌柜控制器和温度验证仪的时间差theresultsofeachBIandCI各生物指示剂和化学指示剂的结果LabeleachdocumentwiththeequipmentID,loaddescription,date,testrunnumberandcyclestart/endtime.每个记录分别标明设备ID、负载说明、日期、测试编号和循环开始/结束时间。Ifyoufailtogenerategooddocumentationwhileconductingthevalidationtestruns,youwillnotbeabletoanalysethedatawhenputtingtogetherthereport.Inadequateorpoorqualitydatatosupportthevalidationprocesswillnotsurvivethescrutinyofanauditor.当进行验证测试过程中，如果你没有良好记录，在报告时，你将无法进行数据分析。用不充分或不良的数据来支持验证过程将无法通过审计。Tip:提示Becautiousabouttheacceptancecriteriayouemploytoverifytheaccuracyofthermocouples.Ifthecriterionistootight(e.g.,allthermocouplesmustmeettheacceptancecriteria),youmaylosealotofrunsifoneortwothermocouplesceasefunctioningorareoutsidethetemperaturetoleranceaftertheruns.注意谨慎使用热电偶的精确度接受标准，如果标准过高（如所有的热电偶必须达到接受标准），如有一或两个热电偶停止工作或在测试后超出温度容许偏差，则可能会丢失大量运行。Consideration8Thefrequencyofthermocoupleaccuracyverification注意事项8：热电偶准确度确认的频率Ifyouareperformingalargenumberoftestruns(e.g.,overthecourseofseveralweeks),youneedtothinkaboutthepointsatwhichyouwillverifythethermocouples'accuracy.Thiscouldbedoneaftereveryrunand/orattheendoftheentiretestingperiod.Ifyouwaituntiltheendofthetestingperiod,youruntheriskthatalloftherunsareofnovalueduetotheirfailuretomeettheverificationacceptancecriteria.Verifyingaftereveryrun,however,addsconsiderablytothelengthoftimerequiredtocompletethetesting.Performingtheverificationeverythreerunsoreveryfewdaysisareasonablecompromise.如果你正在进行（如，在几个星期内）大量的验证测试，你需要考虑热电偶的准确度。可以在每次运行和/或在整个测试周期结束后进行。如果等到测试周期结束,则存在由于热电偶未满足接受验收标准而导致所有测试失效的风险。但是，在每次测试后做检查，则会大大增加完成测试所需的时间。每三次运行或每隔几天执行一次准确性检查是一种合理的折衷方案。AsnotedinConsideration6,theacceptancecriterionyouemploytoverifythethermocouples'accuracyshouldallowatleastoneortwothermocouplestofail.正如注意事项6指出，验证热电偶的准确度，应允许至少一个或两个热电偶失效。Consideration9Havingadequatetimeandaccesstotheautoclavetocompletethevalidation注意事项9：确保足够的时间和支配来完成验证It’seasytounderestimatethelengthoftimeittakestovalidateanautoclave,andhowmuchaccessyouneedtoitduringtheprocess.人们很容易低估验证高温灭菌器所需的时间，以及在整个验证过程中你需要做些什么。Forexample,itcantakeuptofourhourstosetupyourrun,i.e.,preparetheload,placeprobes,BIsandCIsintotheload,etc.IfProductionneedstousetheautoclaveandyouneedtoremoveyourprobes,BIsandCIs,thenyouneedtostartalloveragain,effectivelylosingaday.WorkwiththeProductiondepartmentwhenplanningtheValidationprojecttoensurethatyouhaveadequateaccesstotheautoclave.例如，可能需要长达四个小时进行准备，例如，准备装载，放置探头，将BI和CI放入负载中等。如果生产需要使用高压灭菌器，你需要将探头，BI和CI挪出来，然后从头再来，白白浪费一天。在规划验证项目时与生产部门合作，以确保你能有足够的支配。AnotherapproachistocombinePhaseIIandIII(HeatDistribution)withPhaseIV(HeatPenetration)studiestosavetime.另一种方法是将阶段II、阶段III（热分布）与阶段IV（热渗透）结合在一起，以节省时间。Combiningthesethreephasescouldreducethetimeittakestocompletethevalidationproject;however,youneedtoconsiderthefollowingwhendoingthis:这三个阶段结合一起做可以减少完成验证的时间，不过，这样做需要考虑以下几点：1Youwillneedtoplaceprobesintothechamberandintoloaditemsatthesametime.Canyoufitalltheprobesthroughtheautoclave'sinlet?Ifnot,thenyouneedtoeithervalidateeachphaseseparately,orreducethenumberofprobes.1、需要同时将探头放入墙体内和负载物上。通过高压灭菌器验证口你能安装所有的探头吗？如果不能，那么你需要单独验证每个阶段，或降低探头的数量。2Combiningthesethreephasesgreatlyincreasesyourpreparationtime.Ifyouareworkingonatightschedule(e.g.,onaconstructionsitewhereyouneedtoevacuateatacertaintime),youmaynothavetimetocompletethestudy.Ifthishappens,thenitmaytakemoretimetoperformtheworkthanifyouhaddoneeachphaseseparately.2、这三个阶段结合在一起做会大大增加你的准备时间。如果你的时间较紧(例如，在需要在特定时间撤离的建筑工地上),，你可能没有时间完成这项分析。如果发生这种情况，那么它需要完成的时间比单独做每个阶段的时间要长。3Ifyouareundertimepressure,thereisagreaterchancethatyouwillmisssomethingormakeamistake.3、如果你的时间很紧，将很容易遗忘一些东西或者犯错误。4Therearemoredatatoconsider.Ifyoucheckonlyafewcriticalrequirementsbeforeproceedingtothenextstudy,youmaymisssomethingthatdidnotmeetanacceptancecriterion.Thismaymeanthatallsubsequentstudiesareatrisk,becausethedatacannotbeverified.Forexample,aprobemaybefalselyreadingtoohigh.4、还有更多的数据需要考虑。进行下一个研究前，如果你只检查了几个关键点，您可能会疏忽一些不符合验证标准的内容，这可能意味着所有后续的研究处于风险之中，因为数据无法得到证实。例如，一个探头读数可能过高。5Allowenoughtimeforthereporttobecompleted.5、准备充足的时间来完成报告。Ifyouarevalidatinganewautoclave,thenyouneedtoallowenou