微生物限度USP36

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1、58á55ñBiologicalIndicatorsÐResistancePerformanceTests/MicrobiologicalTestsUSP36ItispreferabletousethesamemethodasthatdefinedbyENUMERATIONMETHODSthebiologicalindicatormanufacturertodetermineDvalues.TheuseofadifferentmethodcanresultindifferencesthatUsetheMembraneFiltrationmethodoroneofthePla

2、te-aremoreanartifactofthemethodthanavariationintheCountMethods,asdirected.TheMost-Probable-Numberperformanceofthebiologicalindicator.(MPN)Methodisgenerallytheleastaccuratemethodformicrobialcounts;however,forcertainproductgroupswithSurvivalTimeandKillTimeverylowbioburden,itmaybethemostappro

3、priatemethod.Taketwogroups,eachconsistingof10specimensoftheThechoiceofamethodisbasedonfactorssuchastherelevantbiologicalindicator,intheiroriginal,individualcon-natureoftheproductandtherequiredlimitofmicroorgan-tainers.Placethespecimensofagroupinsuitablespecimenisms.Themethodchosenmustallow

4、testingofasufficientholdersthatpermiteachspecimentobeexposedtothesamplesizetojudgecompliancewiththespecification.ThesterilizingconditionsataspecificlocationintheBIERcham-suitabilityofthechosenmethodmustbeestablished.ber.Exposethespecimensfortherequiredsurvivaltime,enterGROWTHPROMOTIONTEST,

5、SUITABILITYthechamber,andremovetheholder(s)containingthe10specimens.Repeattheaboveprocedureimmediately,orOFTHECOUNTINGMETHODANDNEGATIVEpreheatifasubstantialintervalhaselapsed,soastosubjectCONTROLSthesecondholder(s)containing10specimenssimilarlytothefirstconditions,butfortherequiredkilltime

6、.TheSurvivaltimeandkilltimeforallmonographedbiolog-GeneralConsiderationsicalindicatorsisdescribedintheofficialmonographundertheheadingforeach.Theabilityofthetesttodetectmicroorganismsinthepresenceofproducttobetestedmustbeestablished.Suitabilitymustbeconfirmedifachangeintestingper-formanceo

7、rachangeintheproductthatmayaffecttheoutcomeofthetest,isintroduced.á61ñMICROBIOLOGICALPreparationofTestStrainsEXAMINATIONOFNONSTERILEUsestandardizedstablesuspensionsofteststrainsorpre-pareasstatedbelow.Seed-lotculturemaintenancetech-PRODUCTS:MICROBIALniques(see