AAMITIR16中英对照_原创文档.pdfVIP

AAMITIR16-2017

3processandequipmentcharacterization

3.1sterilizationequipment

GuidelinesforequipmentselectioncanbefoundinAAMITIR15andEN1422.Careful

selectionofsterilizingequipmentanddevelopmentofthefacilitydesignwillenablea

manufacturertoprocessaproductsafelyandeffectively.

3工艺和设备表征

3.1灭菌设备

设备选择指南可在AAMITIR15和EN1422中找到。仔细选择消毒设备和开发设施设计将使

制造商能够安全有效地处理产品。

3.2processcharacterization—physicalparameters

3.2.1introduction

Thevariablesthathaveasignificanteffectonthelethalityofanethyleneoxide(EO)

sterilizationprocessareEOconcentration,temperature,EOexposuretime,andoftenrelative

humidity(RH).Thesevariablesareinterrelatedandachangeinonecanoftenbecompensated

forbyachangeinanother.Otheraspectsthatmightaffectlethalityaretheactualdepthand

rateofevacuationsduringthesterilant-removalphasesasevacuationscanbeaffectedby

chambertemperature,humidity,sterilantlevels,vacuumpumpperformance,and/orproduct

loadconfiguration.

3.2过程表征-物理参数

3.2.1介绍

对环氧乙烷（EO）灭菌过程的致死率具有显着影响的变量是EO浓度，温度，EO暴露时间

和通常相对湿度（RH）。这些变量是相互关联的，一个变量通常可以通过另一个变化来补

偿。可能影响致死率的其他方面是消毒剂去除阶段期间的实际深度和疏散速率，因为抽空

可能受室温，湿度，消毒剂水平，真空泵性能和/或产品负载配置的影响。

3.2.2EOconcentration

CommonpracticeistodevelopandqualifycyclesusinganEOconcentrationrangingfrom

400to650milligramsperliter(mg/L),becauseconcentrationsinthisrangehavebeenfound

toachievemicrobiologicallethalityformostproductswithinareasonableandpractical

exposuretime.WhenlowerEOconcentrationsarenecessaryduetoproductsorprocess

considerations,theexposuretimemightneedtobeincreasedtoachievethesamelethality;

however,thetimeincreasecanbemitigatedifthet