USP301211翻译灭菌和无菌保证Word格式.docx

USP301211翻译灭菌和无菌保证Word格式.docx

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1211STERILIZATIONANDSTERILITYASSURANCEOFCOMPENDIALARTICLES

灭菌和无菌保证纲要条款

Thisinformationalchapterprovidesageneraldescriptionoftheconceptsandprinciplesinvolvedinthequalitycontrolofarticlesthatmustbesterile.AnymodificationsoforvariationsinsterilitytestproceduresfromthosedescribedunderSterilityTests71shouldbevalidatedinthecontextoftheentiresterilityassuranceprogramandarenotintendedtobemethodsalternativetothosedescribedinthatchapter.

报告章节规定涉及到条款质量控制总的概念描述和原则是必须是无菌的.从无菌测试<

71>

的章节描述中,无菌保证程序的整个上下文中规定没有可选择的方法,任何有关无菌测试程序变更或修改应该得到验证.

Withinthestrictestdefinitionofsterility,aspecimenwouldbedeemedsterileonlywhenthereiscompleteabsenceofviablemicroorganismsfromit.However,thisabsolutedefinitioncannotcurrentlybeappliedtoanentirelotoffinishedcompendialarticlesbecauseoflimitationsintesting.Absolutesterilitycannotbepracticallydemonstratedwithoutcompletedestructionofeveryfinishedarticle.

在最严格的无菌定义里,仅当它不含有任何可存的微生物,样品才被认为无菌.然而,因为测试的局限性，这个绝对的定义不能普遍应用到整个纲要条款中。

实际上每个灭菌的物品没有完全的破坏，绝对无菌性不能得到论证。

Thesterilityofalotpurportedtobesterileisthereforedefinedinprobabilisticterms,wherethelikelihoodofacontaminatedunitorarticleisacceptablyremote.Suchastateofsterilityassurancecanbeestablishedonlythroughtheuseofadequatesterilizationcyclesandsubsequentasepticprocessing,ifany,underappropriatecurrentgoodmanufacturingpractice,andnotbyreliancesolelyonsterilitytesting.

Theprinciplesandimplementationofaprogramtovalidateanasepticprocessingprocedurearesimilartothevalidationofasterilizationprocess.Inasepticprocessing,thecomponentsofthefinaldosageformaresterilizedseparatelyandthefinishedarticleisassembledinanasepticmanner.

验证一个无菌处理程序的法则和执行和灭菌过程的确认是相似的.在无菌处理中,最终剂量组成成分是分别灭菌的,最后物品的组装是在无菌方式完成的.

Propervalidationofthesterilizationprocessortheasepticprocessrequiresahighlevelofknowledgeofthefieldofsterilizationandcleanroomtechnology.Inordertocomplywithcurrentlyacceptableandachievablelimitsinsterilizationparameters,itisnecessarytoemployappropriateinstrumentationandequipmenttocontrolthecriticalparameterssuchastemperatureandtime,humidity,andsterilizinggasconcentration,orabsorbedradiation.灭菌过程或无菌程序正确确认要求较高的灭菌和绝对无尘室技术领域的知识水平.Animportantaspectofthevalidationprograminmanysterilizationproceduresinvolvestheemploymentofbiologicalindicators（seeBiologicalIndicators1035）.在许多灭菌程序一个重要的确认纲要方面包括生物指示剂的使用（参见生物指示剂<

1035>

-）.Thevalidatedandcertifiedprocessshouldberevalidatedperiodically;

however,therevalidationprogramneednotnecessarilybeasextensiveastheoriginalprogram.验证和鉴定的程序应当定时性地重新生效,然而,重新生效程序不必像原始文件那样广泛.

Atypicalvalidationprogram,asoutlinedbelow,isonedesignedforthesteamautoclave,buttheprinciplesareapplicabletotheothersterilizationproceduresdiscussedinthisinformationalchapter.Theprogramcomprisesseveralstages.一个典型的确认程序如下列大纲,一个蒸汽高压灭菌锅设计而作,但原理也是适用于其它的灭菌程序,将在报告章节讨论.

Theinstallationqualificationstageisintendedtoestablishthatcontrolsandotherinstrumentationareproperlydesignedandcalibrated.Documentationshouldbeonfiledemonstratingthequalityoftherequiredutilitiessuchassteam,water,andair.限定时期安装目的建立调节装置和其它的使用仪器能够得到适当设计和校准.文件能够记录下来备查证明要求效用的质量像蒸汽,水,空气.Theoperationalqualificationstageisintendedtoconfirmthattheemptychamberfunctionswithintheparametersoftemperatureatallofthekeychamberlocationsprescribedintheprotocol.可操作资格的时期是打算确认在协议规定的所有关键锅室区域在温度参数以内的锅室功能.Itisusuallyappropriatetodevelopheatprofilerecords,i.e.,simultaneoustemperaturesinthechamberemployingmultipletemperature-sensingdevices.它通常适用于显示压力剖面的记录也就是在锅室使用多种温度敏感装置Atypicalacceptablerangeoftemperatureintheemptychamberis±

1whenthechambertemperatureisnotlessthan121.当锅室温度不少于121,一个典型的可接受的锅室温度幅度范围是±

1.Theconfirmatorystageofthevalidationprogramistheactualsterilizationofmaterialsorarticles.确认程序的确认时期是原料或物品实际灭菌期.Thisdeterminationrequirestheemploymentoftemperature-sensingdevicesinsertedintosamplesofthearticles,aswellaseithersamplesofthearticlestowhichappropriateconcentrationsofsuitabletestmicroorganismshavebeenadded,orseparateBIsinoperationallyfullyloadedautoclaveconfigurations.决定要求温度敏感装置嵌入到物品样本中,除了添加微生物测试需要的适当的物品浓度,或在操作上二度单独的装满物品的高压灭菌锅装置.Theeffectivenessofheatdeliveryorpenetrationintotheactualarticlesandthetimeoftheexposurearethetwomainfactorsthatdeterminethelethalityofthesterilizationprocess.Thefinalstageofthevalidationprogramrequiresthedocumentationofthesupportingdatadevelopedinexecutingtheprogram.热传递或穿透实际物品的效力和曝光时间是两个主要的因素决定灭菌程序的破坏性.确认的最终阶段需要执行程序的数据支持文件发展更新.

Itisgenerallyacceptedthatterminallysterilizedinjectablearticlesor