美国药典USP31-NF26无菌检查法《71》翻译

ŽýoxUSP31-NF26àÌÀåÕ71.doc71STERILITYTESTSàÌÀåÕPortionsofthisgeneralchapterhavebeenharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopeiaand/ortheJapanesePharmacopeia.Thoseportionsthatarenotharmonizedaremarkedwithsymbols()tospecifythisfact.d„èòÏ'2oxŒ/å,ox„ù”èZ†Oô„è(&÷ eThefollowingproceduresareapplicablefordeterminingwhetheraPharmacopeialarticlepurportingtobesterilecomplieswiththerequirementssetforthintheindividualmonographwithrespecttothetestforsterility.PharmacopeialarticlesaretobetestedbytheMembraneFiltrationmethodunderTestforSterilityoftheProducttobeExaminedwherethenatureoftheproductpermits.Ifthemembranefiltrationtechniqueisunsuitable,usetheDirectInoculationoftheCultureMediummethodunderTestforSterilityoftheProducttobeExamined.Alldevices,withtheexceptionofDeviceswithPathwaysLabeledSterile,aretestedusingtheDirectInoculationoftheCultureMediummethod.ProvisionsforretestingareincludedunderObservationandInterpretationofResults.bٛe¤(ŽKš/&Ð*(ŽàÌ(„oÁ/&&vwS„º-sŽàÌÀ儁Bêv'(¸ïٛoÁ(›Õ§ÁàÌÀåÕy„œÇäÕeÀK‚œœÇä€//„((›Õ§ÁàÌÀåÕy„ù{úô¥¥ÍÕd†w °:àÌS„¾K@ „¾G{(ù{úô¥¥ÍÕÛLÀK(Ӝ„ÂKãy+†Œ„ÄšBecausesterilitytestingisaveryexactingprocedure,whereasepsisoftheproceduremustbeensuredforacorrectinterpretationofresults,itisimportantthatpersonnelbeproperlytrainedandqualified.Thetestforsterilityiscarriedoutunderasepticconditions.Inordertoachievesuchconditions,thetestenvironmenthastobeadaptedtothewayinwhichthesterilitytestisperformed.Theprecautionstakentoavoidcontaminationaresuchthattheydonotaffectanymicroorganismsthataretoberevealedinthetest.Theworkingconditionsinwhichthetestsareperformedaremonitoredregularlybyappropriatesamplingoftheworkingareaandbycarryingoutappropriatecontrols.1ŽàÌÀåÕ/*^8¾n„(dÇ-„à̶
Å{—0nÝ垰ùӜ„cnãàdºXÏÇS„ù­v֗D(/^8́„àÌÀå(àÌaöÛL:†ž°Ù7„aöՌ¯ƒÅ{t0ÛLàÌÀ儹:MaÓÇքyš„2ª½”ùûUÕþ(Àå-Ñ°„®i§qÍÇ(å\:ß\SÖ7vÛLS§6ešÑKÛLdՌ„å\aöThesePharmacopeialproceduresarenotbythemselvesdesignedtoensurethatabatchofproductissterileorhasbeensterilized.Thisisaccomplishedprimarilybyvalidationofthesterilizationprocessoroftheasepticprocessingprocedures.ٛoxĚê«„¾¡ýnÝy§ÁàÌòÏmÌÙ;/ÇmÌåzàÌÍ\„ŒÁeŒWhenevidenceofmicrobialcontaminationinthearticleisobtainedbytheappropriatePharmacopeialmethod,theresultsoobtainedisconclusiveevidenceoffailureofthearticletomeettherequirementsofthetestforsterility,evenifadifferentresultisobtainedbyanalternativeprocedure.Foradditionalinformationonsterilitytesting,seeSterilizationandSterilityAssuranceofCompendialArticles1211.SÇS„ox¹Õ·—†ÐiÁ-®iaӄÁnÙ7·—„Óœ/åiÁ*ý¾0àÌÀŒB„Óº'Áns¿(ÿ㏗0†„Óœ_àÕ&šdӜ‚·—sŽàÌÀŒ„vÖáoÁoÁ„m̌àÌÝÁ1211MEDIAù{úPreparemediaforthetestsasdescribedbelow,ordehydratedformulationsmaybeusedprovidedthat,whenreconstitutedasdirectedbythemanufacturerordistributor,theymeettherequirementsoftheGrowthPromotionTestofAerobes,Anaerobes,andFungi.Mediaaresterilizedusingavalidatedprocess. gbÏð„¹ÕM6žŒ(ù{ú(14ù{úê9nv6FFôÛLbKvý&}'Ì
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ÌÃÛՌ„Bsï(ÏnjÁ„åzùù{úÛLmÌÍ\Thefollowingculturemediahavebeenfoundtobesuitableforthetestforsterility.FluidThioglycollateMediumisprimarilyintendedforthecultureofanaerobicbacteria.However,itwillalsodetectaerobicbacteria.SoybeanCaseinDigestMediumissuitableforthecultureofbothfungiandaerobicbacteria.b„ù{úòÏ«ÁžÛLàÌÀåïú‹xвSù{ú;(ŽŒ'̄ù{Fv_(ŽÀK}'Ì'FjË}ˆiù{úŽù{ ̌}'ÌFluidThioglycollateMediumïú‹xвSù{úL-CystineL-ñ(x0.5gSodiumChloride/ 2.5gDextrose(C6H12O6·H2O)aÖ5.5/5.0gAgar,granulated(moisturecontentnotexceeding15%)H—’¶(4+υÇ15%)0.75gYeastExtract(water-soluble)uÍÐÖi(4¶')5.0gPancreaticDigestofCaseinjË}ðvˆi15.0gSodiumThioglycollateïúYx 0.5gorThioglycolicAcidïúYx0.3mLResazurinSodiumSolution(1in1000),freshlyprepared)R ¶²(1Ô1000)°M61.0mLPurifiedWater¯À41000mLMixtheL-cystine,sodiumchloride,dextrose,yeastextract,andpancreaticdigestofcaseinwiththepurifiedwater,andheatuntilsolutioniseffected.Dissolvethesodiumthioglycollateorthioglycolicacidinthesolutionand,ifnecessary,add1Nsodiumhydroxidesothat,aftersterilization,thesolutionwillhaveapHof7.1±0.2.Iffiltrationisnecessary,heatthesolutionagainwithoutboiling,andfilterwhilehotthroughmoistenedfilterpaper.Addtheresazurinsodiumsolution,mix,andplacethemediuminsuitablevesselsthatprovidearatioofsurfacetodepthofmediumsuchthatnotmorethantheupperhalfofthemediumhasundergoneacolorchangeindicativeofoxygenuptakeattheendoftheincubationperiod.Sterilizeusingavalidatedprocess.Ifthemediumisstored,storeatatemperaturebetween2and25inasterile,airtightcontainer.Ifmorethantheupperone-thirdofthemediumhasacquiredapinkcolor,themediummayberestoredoncebyheatingthecontainersinawater-bathorinfree-flowingsteamuntilthepinkcolordisappearsandbycoolingquickly,takingcaretopreventtheintroductionofnonsterileairintothecontainer.L-ñ(x
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