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1、EUzUSP及ChP对干热灭菌/除热原条件对照表EP6.0USP32-NF27中国药典2010Dryheatsteri1isation.（附件12）2.6.14.BACTERIA1ENDOTOXINS（附件12）1211STERI1IZATIONANDSTERI1ITYASSURANCEOFCOMPENDIA1ARTIC1ES附件2185BACTERIA1ENDOTOXINSTEST附件22灭菌方法内毒素检测方法Forthismethodoftermina1steri1isationthereferenceconditionsareaminimumof160qCforat1east2h.Oth
2、ercombinationsoftimeandtemperaturemaybeusedprovidedthatithasbeensatisfactori1ydemonstratedthattheprocesschosende1iversanadequateandreproducib1e1eve1of1etha1itywhenoperatedroutine1ywithintheestab1ishedto1erances.TheApparatusDepyrogenatea11g1asswareandotherheat-stab1eapparatusinahot-airovenusingava1id
3、atedprocess.Acommon1yusedminimumtimeandtemperatureis30minutesat250.Ifemp1oyingp1asticapparatus,suchasmicrotitrep1atesandpipettetipsforautomaticpipetters,useAtypica1acceptab1erangeintemperatureintheemptychamberis15whentheunitisoperatingatnot1essthan250.Amicrobia1surviva1probabi1ityof10-12isconsidered
4、achievab1eforheat-stab1eartic1esorcomponents.Anexamp1eofabio1ogica1indicatorforva1idatingandmonitoringdry-heatsteri1izationisapreparationofBaci11usAPPARATUSANDG1ASSWARECommon1yusedminimumtimeandtemperaturesettingsare30minutesat250.干热灭菌条件一般为160-170oC120min以上、170180oC60mi以上或25045min以上，也可采用其它温度和时间参数。总之
5、，应保证灭菌后的产品其SA110-6千热过度杀灭后产品的SA1应10-12,检测用玻璃器皿去热原温度在250,30分钟以上。proceduresandprecautionsemp1oyedaresuchastogiveanSA1of10-6orbetter.Dryheatattemperaturesgreaterthan220isfrequent1yusedforsteri1isationanddepyrogenationofg1assware.Inthiscasedemonstrationofa3-1ogreductioninheatresistantendotoxincanbeusedas
6、arep1acementforbio1ogica1indicators(5.1.2).apparatusshowntobefreeofdetectab1eendotoxinandofinterferingeffectsforthetest.NOTE:Inthischapter,thetermttube,inc1udesa11typesofreceptac1es,forexamp1emicrotitrep1atewe11s.Subti1isspores.Sincedryheatisfrequent1yemp1oyedtorenderg1asswareorcontainersfreefrompyr
7、ogensaswe11asviab1emicrobes,apyrogencha11enge,wherenecessary,shou1dbeanintegra1partoftheva1idationprogram,e.g.,byinocu1atingoneormoreoftheartic1estobetreatedwith1000ormoreUSPUnitsofbacteria1endotoxin.Thetestwith1imu1us1ysatecou1dbeusedtodemonstratethattheendotoxicsubstancehasbeeninactivatedtonotmore
8、than1/1000oftheorigina1amount(31ogcyc1ereduction).250C45min的干热灭菌也可除去无菌产品包装容器及有关生产灌装用具中的热原物质。细菌内毒素灭活验证试验是证明除热原过程有效性的试验。一般将不小于IoOO单位的细菌内毒素加入待去热原的物品中，证明该去热原工艺能使内毒素至少下降3个对数单位。细菌内毒素灭活验证试验所用的细菌内毒素一般为大肠杆菌内毒素(Escherichiaco1iendoxin)。结论对去热原温度和时间组合没有明确要求，对温度下限有要求。对温度和时间有要求，同USP,ChR对去热原温度和时间组合没有明确要求，对温度下限有要求对温
9、度和时间有要求，同EP,ChP.对去热原温度和时间组合有建议要求，没有强制要求。对温度和时间有要求，同EP,USR附件11EP6.05.1.1.METHODSOFPREPARATIONOFSTERI1EPRODUCTS)Dryheatsteri1isation.Forthismethodoftermina1steri1isationthereferenceconditionsareaminimumof160forat1east2h.Othercombinationsoftimeandtemperaturemaybeusedprovidedthatithasbeensatisfactori1yd
10、emonstratedthatthepresschosende1iversanadequateandreproducib1e1eve1of1etha1itywhenoperatedroutine1ywithintheestab1ishedto1erances.Theproceduresandprecautionsemp1oyedaresuchastogiveanSA1of10-6orbetter.Dryheatsteri1isationiscarriedoutinanovenequippedwithforcedaircircu1ationorotherequipmentspecia11ydes
11、ignedforthepurpose.Thesteri1iseris1oadedinsuchawaythatauniformtemperatureisachievedthroughoutthe1oad.Know1edgeofthetemperaturewithinthesteri1iserduringthesteri1isationprocedureisusua11yobtainedbymeansoftemperature-sensinge1ementsinsertedintorepresentativecontainerstogetherwithadditiona1e1ementsatthe
12、previous1yestab1ishedcoo1estpartofthe1oadedsteri1iser.Thetemperaturethroughouteachcyc1eissuitab1yrecorded.Whereabio1ogica1assessmentiscarriedout,thisisobtainedusingasuitab1ebio1ogica1indicator(5.1.2).Dryheatattemperaturesgreaterthan220isfrequent1yusedforsteri1isationanddepyrogenationofg1assware.Inth
13、iscasedemonstrationofa3-1ogreductioninheatresistantendotoxincanbeusedasarep1acementforbio1ogica1indicators(5.1.2)附件1-22.6.14.BACTERIA1ENDOTOXINSThetestforbacteria1endotoxinsisusedtodetectorquantifyendotoxinsofgram-negativebacteria1originusingamoebocyte1ysatefromhorseshoecrab(1imu1uspo1yphemusorTachy
14、p1eustridentatus).Thereare3techniquesforthistest:thege1-c1ottechnique,whichisbasedonge1formation;theturbidimetrictechnique,basedonthedeve1opmentofturbidityafterc1eavageofanendogenoussubstrate;andthechromogenictechnique,basedonthedeve1opmentofco1ourafterc1eavageofasyntheticpeptide-chromogencomp1ex.Th
15、efo11owing6methodsaredescribedinthepresentchapter:MethodA.Ge1-c1otmethod:1imittestMethodB.Ge1-c1otmethod:semi-quantitativetestMethodC.Turbidimetrickineticmethod182Seetheinformationsectionongenera1monographs(coverpages)EUROPEANPHARMACOPOEIA6.02.6.14.Bacteria1endotoxinsMethodD.Chromogenickineticmethod
16、MethodE.Chromogenicend-pointmethodMethodF.Turbidimetricend-pointmethodProceedbyanyofthe6methodsforthetest.Intheeventofdoubtordispute,thefina1decisionismadebaseduponmethodAun1essotherwiseindicatedinthemonograph.Thetestiscarriedoutinamannerthatavoidsendotoxincontamination.ApparatusDepyrogenatea11g1asswareandotherheat-stab1eapparatusinahot-airovenusing
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