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1、<61}MICROBIALLIMITTESTS微生物限度检查法Thischapterprovidestestsfortheestimationofthenumberofviableaerobicmicroorganismspresentandforfreedomfromdesignatedmicrobialspeciesinpharmaceuticalarticlesofallkinds,fromrawmaterialstothefinishedforms・Anautomatedmethodmaybesubstitutedforthetestspresentedhere,provided
2、ithasbeenproperlyvalidatedasgivingequivalentorbetterresults.Inpreparingforandinapplyingthetests,observeasepticprecautionsinhandlingthespecimens.Unlessotherwisedirected,wheretheprocedurespecifiessimply“incubate,”holdthecontainerinairthatisthermostaticallycontrolledatatemperaturebetween30°and35°,fo
3、raperiodof24to48hours.Theterm“growth”isusedinaspecialsenseherein,i.e.,todesignatethepresenceandpresumedproliferationofviablemicroorganisms.此章节提供了检验方法，以便在所有种类的药用物品一一从原料到成品中，估计其中存在的各种好氧微生物的数量，并确保其不含有指定种类的微生物。只要已经通过验证证明自动方法能够产牛相等或更好的结果，即可用其代替在此呈现的方法。在准备和实施此试骑的过程中，注意处理样品时的无菌预防措施。除另有规定，当操作步骤仅要求“培养”，将该
4、溶液置于恒温控制在30°与35°之间的空气中24至48小时。名词“生长”在此用于特殊的含义，例如指明各种微生物的存在与推测的增殖。PREPARATORYTESTING预备试验Thevalidityoftheresultsofthetestssetforthinthischapterrestslargelyupontheadequacyofademonstrationthatthetestspecimenstowhichtheyareapplieddonot,ofthemselves,inhibitthemultiplication,underthetestconditions,ofmic
5、roorganismsthatmaybepresent.Therefore,preparatorytoconductingthetestsonaregularbasisandascircumstancesrequiresubsequently,inoculatedilutedspecimensofthematerialtobetestedwithseparateviableculturesofStaphylococcusaureus,Escherichiacoli,Pseudomonasaeruginosa,andSalmonella.Thiscanbedonebyadding1mLof
6、notlessthan10"3dilutionofa24-hourbrothcultureofthemicroorganismtothefirstdilution(inpH7.2PhosphateBuffer,FluidSoybean-CaseinDigestMedium,orFluidLactoseMedium)ofthetestmaterialandfollowingthetestprocedure.Failureoftheorganism(s)togrowintherelevantmediuminvalidatesthatportionoftheexaminationandnece
7、ssitatesamodificationoftheprocedureby(1)anincreaseinthevolumeofdiluent,thequantityoftestmaterialremainingthesame,orby(2)theincorporationofasufficientquantityofsuitableinactivatingagent(s)inthediluents,orby(3)anappropri
