Designation:D5022−07StandardSpecificationforIdentificationofVialsandAmpoulesContainingConcentratedSolutionsofDrugstobeDilutedBeforeUse1ThisstandardisissuedunderthefixeddesignationD5022;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationdealswithidentificationofsmallvolumecontainersofdrugsintendedtobedilutedbeforeparenteraladministration,asfollows:1.1.1Containershape,1.1.2Labelingstatements.1.1.3VialclosuresandFlip-Off,2typecaps,and1.1.4Ampoulemarking.2.ReferencedDocuments2.1ASTMStandards:3D996TerminologyofPackagingandDistributionEnviron-mentsD4267SpecificationforLabelsforSmall-Volume(100mLorLess)ParenteralDrugContainersD4775SpecificationforIdentificationandConfigurationofPrefilledSyringesandDeliverySystemsforDrugs(Ex-cludingPharmacyBulkPackages)D7298TestMethodforMeasurementofComparativeLeg-ibilitybyMeansofPolarizingFilterInstrumentation2.2OtherStandards:PantoneMatchingSystemsCurrentEdition43.Terminology3.1Generaldefinitionsforpackaginganddistributionenvi-ronmentsarefoundinTerminologyD996.3.2ampoule—ahermeticallysealed,smallbulbousglassorplasticvessel;openingisachievedbybreakingthestem(alsoampuleorampul).3.3vial—asmall,usuallycylindrical,vesselcapableofclosure,suchasformedications,perfumes,essences,andsamples.3.4DescriptionofTermsSpecifictoThisStandard:3.4.1Flip-Offtypecap—aplasticcapwhichmustbere-movedtoexposetheinjectionportintheelastomericandmetalvialclosure.4.Requirements4.1Drugsinliquidformrequiringdilutionbeforeparenteraladministrationshallnotbepackagedincontainersthatre-sembleanormalsyringe.Thedesignofsuchcontainersshallprecludedirectintravenouslineinjectionofthesolution.4.2Thelabelsonsuchcontainers(forexample,vialsandampoules)shallbearthewords“DiluteBeforeUse”,orsimilarwarning,intypewithinitialcapitalsatleast2.5mminvertic...
