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1、61MICROBIALLIMITTESTSThischapterprovidestestsfortheestimationofthenumberofviableaerobicmicroorganismspresentandforfreedomfromdesignatedmicrobialspeciesinpharmaceuticalarticlesofallkinds,fromrawmaterialstothefinishedforms.Anautomatedmethodmaybesubstitutedforthetest
2、spresentedhere,providedithasbeenproperlyvalidatedasgivingequivalentorbetterresults.Inpreparingforandinapplyingthetests,observeasepticprecautionsinhandlingthespecimens.Unlessotherwisedirected,wheretheprocedurespecifiessimply“incubate,”holdthecontainerinairthatisthe
3、rmostaticallycontrolledatatemperaturebetween30and35,foraperiodof24to48hours.Theterm“growth”isusedinaspecialsenseherein,i.e.,todesignatethepresenceandpresumedproliferationofviablemicroorganisms.PREPARATORYTESTINGThevalidityoftheresultsofthetestssetforthinthischapte
4、rrests<61>微生物限度检查本章所提供的检测程序用于测定包括原料药及制剂在内的各种药品中需氧菌数量以及不含有指定的微生物。如果已有充分的证据证明某种自动化的方法可以给出与本章所提供的方法等效的或更好的实验结果，可以用该方法替代本章所提供的方法。在实验准备以及实施的过程中，应遵守无菌操作。除另有规定外，本检查法中“孵育”是指将容器置于温度控制在30-35˚C的空气中24-48小时。术语“生长”在此处是专用于表示存活的微生物的增殖。预试验（验证试验）largelyupontheadequacyofademonstrati
5、onthatthetestspecimenstowhichtheyareapplieddonot,ofthemselves,inhibitthemultiplication,underthetestconditions,ofmicroorganismsthatmaybepresent.Therefore,preparatorytoconductingthetestsonaregularbasisandascircumstancesrequiresubsequently,inoculatedilutedspecimensof
6、thematerialtobetestedwithseparateviableculturesofStaphylococcusaureus,Escherichiacoli,Pseudomonasaeruginosa,andSalmonella.Thiscanbedonebyadding1mLofnotlessthan103dilutionofa24-hourbrothcultureofthemicroorganismtothefirstdilution(inpH7.2PhosphateBuffer,FluidSoybean
7、–CaseinDigestMedium,orFluidLactoseMedium)ofthetestmaterialandfollowingthetestprocedure.Failureoftheorganism(s)togrowintherelevantmediuminvalidatesthatportionoftheexaminationandnecessitatesamodificationoftheprocedureby(1)anincreaseinthevolumeofdiluent,thequantityof
8、testmaterialremainingthesame,orby(2)theincorporationofasufficientquantityofsuitableinactivatingagent(s)inthediluents,orby(3)an应有充分的证据证明在实验条件下检品本身对可能存在微生
