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1、MICROBIALLIMITTESTS（微生物限度检查USP）Thischapterprovidestestsfortheestimationofthenumberofviableaerobicmicroorganismspresentandforfreedomfromdesignatedmicrobialspeciesinpharmaceuticalarticlesofallkinds,fromrawmaterialstothefinishedforms.Anautomatedmethodmaybesubstitutedforthetestspresent
2、edhere,providedithasbeenproperlyvalidatedasgivingequivalentorbetterresults.Inpreparingforandinapplyingthetests,observeasepticprecautionsinhandlingthespecimens.Unlessotherwisedirected,wheretheprocedurespecifiessimply“incubate,”holdthecontainerinairthatisthermostaticallycontrolledata
3、temperaturebetween30and35,foraperiodof24to48hours.Theterm“growth”isusedinaspecialsenseherein,i.e.,todesignatethepresenceandpresumedproliferationofviablemicroorganisms.这一章规定，测试估计的数目可行的好氧微生物，从指定的微生物物种在制药文章的所有品种，从原料到成品的形式。一个自动化的方法，可取代的考验就在这里，只要它已妥善验证给予同等或更好的结果。在准备和在应用试验，观察无菌的预防措施，再处理标
4、本。除非另有指示，凡指定的程序是简单的“孵化”，举行容器中的空气是恒温的控制在温度30至35，时间在24至48小时。相对而言，“增长”是用来在一个特殊的意义在这里，即指定的存在和扩散的微生物。........PreparatoryTesting（筹备测试）Thevalidityoftheresultsofthetestssetforthinthischapterrestslargelyupontheadequacyofademonstrationthatthetestspecimenstowhichtheyareapplieddonot,ofthemselv
5、es,inhibitthemultiplication,underthetestconditions,ofmicroorganismsthatmaybepresent.Therefore,preparatorytoconductingthetestsonaregularbasisandascircumstancesrequiresubsequently,inoculatedilutedspecimensofthematerialtobetestedwithseparateviableculturesofStaphylococcusaureus,Escheri
6、chiacoli,Pseudomonasaeruginosa,andSalmonella.Thiscanbedonebyadding1mLofnotlessthan10-3dilutionofa24-hourbrothcultureofthemicroorganismtothefirstdilution(inpH7.2PhosphateBuffer,FluidSoybean–CaseinDigestMedium,orFluidLactoseMedium)ofthetestmaterialandfollowingthetestprocedure.Failure
7、oftheorganism(s)togrowintherelevantmediuminvalidatesthatportionoftheexaminationandnecessitatesamodificationoftheprocedureby(1)anincreaseinthevolumeofdiluent,thequantityoftestmaterialremainingthesame,orby(2)theincorporationofasufficientquantityofsuitableinactivatingagent(s)inthedilu
8、ents,orby(3)anappropriatec
