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1、2012USP35NF30USP–NFGeneralChapter<797>PharmaceuticalCompounding—SterilePreparationsCopyright©2011TheUnitedStatesPharmacopeialConventionUSP35PhysicalTests/á797ñPharmaceuticalCompounding±Sterile1Table1.ISOClassificationofParticulateMatterinRoomAir(limitsareinparticlesof0.5mmandlargerperc
2、ubicmeter[currentá797ñPHARMACEUTICALISO]andcubicfeet[formerFederalStandardNo.209E,FS209E])*COMPOUNDING±STERILEClassNameParticleCountFS209E,PREPARATIONSISOClassU.S.FS209EISO,m3ft33Class135.214Class10352105Class1003,5201006Class1,00035,2001,000INTRODUCTION7Class10,000352,00010,0008Class1
3、00,0003,520,000100,000Theobjectiveofthischapteristodescribeconditionsand*AdaptedfromformerFederalStandardNo.209E,GeneralServicespracticestopreventharm,includingdeath,topatientsthatAdministration,Washington,DC,20407(September11,1992)andcouldresultfrom(1)microbialcontamination(nonsterili
4、ty),ISO14644-1:1999,Cleanroomsandassociatedcontrolledenviron-(2)excessivebacterialendotoxins,(3)variabilityinthein-mentsÐPart1:Classificationofaircleanliness.Forexample,3,520tendedstrengthofcorrectingredientsthatexceedseitherparticlesof0.5mmperm3orlarger(ISOClass5)isequivalenttomonogra
5、phlimitsforofficialarticles(seeªofficialºandªarti-100particlesperft3(Class100)(1m3=35.2ft3).cleºintheGeneralNoticesandRequirements)or10%fornonofficialarticles,(4)unintendedchemicalandphysicalThestandardsinthischapterareintendedtoapplytoallcontaminants,and(5)ingredientsofinappropriatequ
6、alityinpersonswhoprepareCSPsandallplaceswhereCSPsarecompoundedsterilepreparations(CSPs).Contaminatedprepared(e.g.,hospitalsandotherhealthcareinstitutions,CSPsarepotentiallymosthazardoustopatientswhenad-patienttreatmentclinics,pharmacies,physicians'practicefa-ministeredintobodycavities,
7、centralnervousandvascularcilities,andotherlocationsandfacilitiesinwhichCSPsaresystems,eyes,andjoints,andwhenusedasbathsforliveprepared,stored,andtransported).Personswhoperformorgansandtissues.WhenCSPscontainexcessivebacterialsterilecompoundingincludepharmacists,nurses,pharmacyendotox
