USP40版1117-良好微生物实验室规范

LjungqvistB,ReinmüllerB.Interactionbetweenairmovementsandthedispersionofcontaminants:cleanzoneswithunidir-ectionalairflow.JParenterSciTechnol.1993;47(2):60–69.LjungqvistB,ReinmüllerB.Airborneviableparticlesandtotalnumberofairborneparticles:comparativestudiesofactiveairsampling.PDAJSciTechnol.2000;54:112–116.MaruyamaM,MatsuokaT,DeguchiM,AkersJ.Theapplicationofroboticstoasepticsurfacemonitoring.PharmTechnol.2007;32(7):40–44.Processsimulationtestingforsterilebulkpharmaceuticalchemicals.PDATechnicalReportNo.28.JParenterSciTechnol.1998;52S3.ReinmüllerB.Dispersionandriskassessmentofairbornecontaminantsinpharmaceuticalcleanrooms.BuildingServEngBull(Sweden).2001;BulletinNo.56.StewartSL,GrinshpunSA,WillekeK,TerzievaS,UleviciusV,DonnellyJ.Effectofimpactstressonmicrobialrecoveryonanagarsurface.ApplEnvironMicro.1995;61:1232–1239.WhyteW.Reductionofmicrobialdispersionbyclothing.JParenterSciTechnol.1985;39(1):51–60.á1117ñMICROBIOLOGICALBESTLABORATORYPRACTICESINTRODUCTIONGoodlaboratorypracticesinamicrobiologylaboratoryconsistofactivitiesthatdependonseveralprinciples:aseptictechni-que,controlofmedia,controlofteststrains,operationandcontrolofequipment,diligentrecordingandevaluationofdata,andtrainingofthelaboratorystaff.Becauseoftheinherentriskofvariabilityinmicrobiologydata,reliabilityandreproducibili-tyaredependentontheuseofacceptedmethodsandadherencetogoodlaboratorypractices.MEDIAPREPARATIONANDQUALITYCONTROLMediaPreparationCulturemediaarethebasisformostmicrobiologicaltests.Safeguardingthequalityofthemediaisthereforecriticaltothesuccessofthemicrobiologylaboratory.Mediapreparation,properstorage,andqualitycontroltestingcanensureaconsistentsupplyofhigh-qualitymedia.Itisimportanttochoosethecorrectmediaorcomponentsinmakingmediabasedontheuseofacceptedsourcesorrefer-encesforformulas.Themanufacturer'sformulaandinstructionsforpreparationroutinelyaccompanydehydratedmediaandready-mademedia.Becausedifferentmediatypesmayhavedifferentpreparationrequirements(e.g.,heating,additives,andpHadjustment),itisimportanttofollowtheseinstructionstoensurepreparationofacceptablemediaquality.Acertificateofanalysisdescribingexpirationdatingandrecommendedstorageconditionsaccompaniesready-mademedia,aswellasthequalitycontrolorganismsusedingrowth-promotionandselectivitytestingofthatmedia.Wateristheuniversaldiluentformicrobiologicalmedia.PurifiedWaterismostoftenusedformediapreparation,butincer-taincasestheuseofdeionizedordistilledwatermaybeappropriate.Wateroflesserqualityshouldnotbeusedformicrobio-logicalmediapreparation.Thevolumeofthewaterusedshouldberecorded.Consistentpreparationofmediarequiresaccurateweighingofdehydratedmediaormediaconstituents.Acalibratedbal-ancewiththeappropriateweightrangefortheingredientsshouldbeused(SeeWeighingonanAnalyticalBalanceá1251ñ).Cleanweighingcontainersandtools(suchasspatulas)shouldbeusedtopreventforeignsubstancesfromenteringtheformu-lation.Theweightofthecomponentsshouldberecorded.Dehydratedmediashouldbethoroughlydissolvedinwaterbeforedispensingandsterilization.Ifheatingisnecessarytohelpdissolvethemedia,careshouldbetakennottooverheatmedia,becauseallculturemedia,toagreaterorlesserextent,areheat-sensitive.Equipmentusedinthepreparationofmediashouldbeappropriatetoallowforcontrolledheating,constantagitation,andmixingofthemedia.Darkeningofmedia(Maillard-typereactionornonenzymaticbrowning)isageneralindi-cationofoverheating.Whenaddingrequiredsupplementstomedia,adequatemixingofthemediumafteraddingthesupple-mentshouldbeperformed.Preparationofmediainpoorlycleanedglasswarecanallowinhibitorysubstancestoenterthemedia.Inhibitorysubstancescancomefromdetergentresidueaftercleaningglasswareorfrompriormaterialsusedintheglassware.Besurethattheclean-ingprocessremovesdebrisandforeignmatter,andthatthedetergentisthoroughlyrinsedoutwithPurifiedWater.SeeClean-ingGlassApparatusá1051ñforadditionalguidance.Sterilizationofmediashouldbeperformedwithintheparametersprovidedbythemanufacturerorvalidatedbytheuser.Commerciallypreparedmediashouldprovidedocumentationofthesterilizationmethodused.Autoclavingbymoistheatisthepreferredsterilizationtechnique,exceptininstanceswhenboilingisrequiredinordertoavoiddeteriorationofheat-labilecomponentsofthemedia.Sterilizationbyfiltrationmayalsobeappropriateforsomeformulations.GeneralChaptersUSP40GeneralInformation/á1117ñMicrobiologicalBestLaboratoryPractices1443OfficialfromAugust1,2017Copyright(c)2017TheUnitedStatesPharmacopeialConvention.Allrightsreserved.Accessedfrom27.201.132.211byvp3mtsxgjtkonMonSep2520:58:41EDT2017Theeffectsofthesterilizationmethodandconditionsonthemediashouldbevalidatedbysterilityandgrowth-promotiontestingofthemedia.Inaddition,ifsterilizedbymoistheat,theautoclavecycleshouldbevalidatedtoensureproperheatdis-tributionforselectedloadsandvolumes.Typically,manufacturersrecommendusinganautoclavecycleof121°for15minutesusingavalidatedautoclave.Theseconditionsapplytotimeattemperatureofthemedia.Ascontainersizeandtheloadconfig-urationoftheautoclavewillinfluencetherateofheating,longercyclesmayberequiredforlargerloads