ASTM E3051-16美国材料与试验协会标准.pdfVIP

Designation:E3051−16

StandardGuidefor

Specification,Design,Verification,andApplicationof

Single-UseSystemsinPharmaceuticaland

BiopharmaceuticalManufacturing1

ThisstandardisissuedunderthefixeddesignationE3051;thenumberimmediatelyfollowingthedesignationindicatestheyearof

originaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.A

superscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.

1.Scope2.ReferencedDocuments

1.1ThisguideisintendedasacomplementtoGuideE2500.2.1ASTMStandards:2

1.2ThisguideisapplicabletotherangeofmanufacturingD4169PracticeforPerformanceTestingofShippingCon-

systemsdescribedinGuideE2500,specificallyallelementsoftainersandSystems

single-usesystems,orhybridsofsingle-useandtraditionalE2363TerminologyRelatingtoProcessAnalyticalTechnol-

components,usedforthemanufacturingofpharmaceuticalandogyinthePharmaceuticalIndustry

biopharmaceuticalproducts,including:materialsofE2500GuideforSpecification,Design,andVerificationof

construction,components,assembly,manifolds,supportingPharmaceuticalandBiopharmaceuticalManufacturing

utilities,associatedprocessmonitoringandcontrolsystems,SystemsandEquipment3

automationsystems,andcontrolledenvironmentthathavethe2.2UnitedStatesPharmacopeia:

potentialtoaffectproductqualityan