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1、á61ñMICROBIALLIMITTESTSThischapterprovidestestsfortheestimationofthenumberofviableaerobicmicroorganismspresentandforfreedomfromdesignatedmicrobialspeciesinpharmaceuticalarticlesofallkinds,fromrawmaterialstothefinishedforms.Anautomatedmethodmaybesubstitutedforthetestspresentedhe
2、re,providedithasbeenproperlyvalidatedasgivingequivalentorbetterresults.Inpreparingforandinapplyingthetests,observeasepticprecautionsinhandlingthespecimens.Unlessotherwisedirected,wheretheprocedurespecifiessimply“incubate,”holdthecontainerinairthatisthermostaticallycontrolledata
3、temperaturebetween30and35,foraperiodof24to48hours.Theterm“growth”isusedinaspecialsenseherein,i.e.,todesignatethepresenceandpresumedproliferationofviablemicroorganisms.PREPARATORYTESTINGThevalidityoftheresultsofthetestssetforthinthischapterrestslargelyupontheadequacyofademonstra
4、tionthatthetestspecimenstowhichtheyareapplieddonot,ofthemselves,inhibitthemultiplication,underthetestconditions,ofmicroorganismsthatmaybepresent.Therefore,preparatorytoconductingthetestsonaregularbasisandascircumstancesrequiresubsequently,inoculatedilutedspecimensofthematerialt
5、obetestedwithseparateviableculturesofStaphylococcusaureus,Escherichiacoli,Pseudomonasaeruginosa,andSalmonella.Thiscanbedonebyadding1mLofnotlessthan10-3dilutionofa24-hourbrothcultureofthemicroorganismtothefirstdilution(inpH7.2PhosphateBuffer,FluidSoybean–CaseinDigestMedium,orFlu
6、idLactoseMedium)ofthetestmaterialandfollowingthetestprocedure.Failureoftheorganism(s)togrowintherelevantmediuminvalidatesthatportionoftheexaminationandnecessitatesamodificationoftheprocedureby(1)anincreaseinthevolumeofdiluent,thequantityoftestmaterialremainingthesame,orby(2)the
7、incorporationofasufficientquantityofsuitableinactivatingagent(s)inthediluents,orby(3)anappropriatecombinationofmodifications(1)and(2)soastopermitgrowthoftheinocula.Thefollowingareexamplesofingredientsandtheirconcentrationsthatmaybeaddedtotheculturemediumtoneutralizeinhibitorysu
8、bstancespresentinthesample:soylecithin,0.5%;andpolysor
