清洁验证中的微生物问题--设备表面微生物限度的制定及其检验

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(214092)R117AFDA[21Drugevaluation2004V011No516722809(2004)05038003()()1113(CFU)()?USP(1111)1000CFUg13100CFUg100CFUg200415IOOCFUg27CFUg()3cvug70CFUg514CFUg(CFUcmz)=(IsPxMBS)SALSP(Limitinthesubsequentproduct)MBS(Minimumbatchsize)SA(Productcontactsurfacearea)200kg260000cmLSP14CFUg11CFUcm2Fn(F0=D1*09No+SAW)(N0)FDA21225CFU(1CFUcm2)IOOCFU11CFUam25cmz275CFUl1CFUcHl2250CFU?GMP110CFU275CFU10CFU3822()()250CFU3Drugevaluation2004V011No54l2001360-3952FDAGuidetoInspectionsofValidationofCleaningProcess19933DestinALeBlaneEquipmentCleaningValidationMicrobialCon-trolIssuesJournalofValidationTechnology,20028(4)336342(2004081220041130)(384)7MurakamiTakaoChenChiu-MingoberdieBestandteilederRhizomeVOilWoodwardiaorientalasSwChemPharmBull197119(1)25308GonzalezGonzalezA'CarmenAffayateCasmnasMCandelariaGareiaF,eta1Triterp-enoidsfromWoodwardiaradicansbioehemiealsystematiesandecology200028(5)497-4999ChiuPei-LuPatteronGlennWSaltThomasASterolcompedtionofptefidophytesPhtochemistry198827(3)819-82210]Hanu?LOezankaT,DembitskyVMAtrinorsesterterpeneglyeosidefromtheNorthAmericanfemWoodwardiavirginiea(L)SmithPhtochemistry200363(8)8698751lezankaT'DembitskyVMHanu?LOTwocyclohexenoneglyeosidesfromtheNoahAmericanfernWoodwardiaVirginiea(L)SmithPhytochemistry2003,63(8)931-937121984(6)613BOHMBA1RYONPNOICCOMPoUNDSINFERNS(ASURVEYOFSOMEFERNSFORCINNAMICACIDANDBENIOICACIDDERIVATIVES)CanadianJoum-alofBotany196745585-593141BOHMBAPHENOLICCOMPOUNOSINFERNS-III(ANEX-AMINA7n0NOFSOMEFERNSFORCAFFEICACIDDEIuVA11CEs)Phytichemistry19687(Io)18251830151GLASSADMBOHMBAAFURTHERSURVEY0FFERNSFORCZNNAMICANDBENIOICACIDSPhytochemistry19698(3)6296321619888(1)172017()21995666789-9418122198814519419983040304120200321(5)824-826[21MinByung-SunTomiyama,MiyukiMa,Chao-MeiNakamura,NorioKaempferolacetylrhanmosidesfromtherhizomeofDryopteriserassirhizomaandtheirinhibitoryeffeetdonthreedifferentac-tivitiesofhumanimmunodefieiencyvirus-1reversetranscriptaseChemPharmBull200149(50)546-550(2004-09-102004-11-25)

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