ASTM E2097-2000(2006) 测定非金属材料萃取物对生物技术产品安全性影响的标准指南

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【英文标准名称】:StandardGuideforDeterminingtheImpactofExtractablesfromNon-MetallicMaterialsontheSafetyofBiotechnologyProducts
【原文标准名称】:测定非金属材料萃取物对生物技术产品安全性影响的标准指南
【标准号】:ASTME2097-2000(2006)
【标准状态】:现行
【国别】:
【发布日期】:2000
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E48.03
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:biotechnologyproducts;components;cytotoxicity;extractables;extraction;rawmaterials
【摘要】:Thisguideappliestothedeterminationofthesafetyofnon-metallicmaterialsusedincontactwithbiotechnologyproductcontainingsolutions.Processmaterialsleachlowlevelofresiduesintowater,cellculturemedia,buffers,andotherproductcontainingsolutions.Thisdocumentoffersguidanceondeterminingthesafetyofthesematerials(processmaterials)foruse.Thegoalistopreventtoxicextractablesfromenteringprocessstreamsandultimatelycontaminatingthefinalproductinunacceptablelevels.Thepurposeofthisguideistodescribeteststoqualifymaterialswithrespecttoanyextractablesubstancessoastopreventunintentionalintroductionofapotentialsourceofobjectionablesubstances.Anextractablematerialisobjectionableifitistoxic,interactswithproductconstituents,interfereswithrequiredassays,orotherwiseaffectstheprocessstreamsoastoadverselyaffectcriticalqualityparameters,forexample,purity,safety,efficacy,identity,strengthofthefinalproductoritssuccessfulproduction.Allorganizationsproducingpharmaceuticalproductsshouldconsiderthepointsinthisguidewhenqualifyingprocessmaterialsforuseintheirproductionprocesses.ThisguideoutlinestheapplicationoftheprocessmaterialtestsprimarilyinASTMorUSP.Typicalprocessmaterialsincludehighmolecularweightpolymersandsolidssuchashoses,filters,filterhousings,containers,valvediaphragms,gaskets,o-rings,chromatographyresins,andchromatographiccolumns.Thebatteryoftestsdescribedinthisguideisintendedtocoverawidevarietyofpotentialattributesofmaterialsandtocharacterizepossibleextractables.Thematerialspecificationwillvarydependingontheimpactonthefinalproductandthepointintheprocessthattheproductsolutioncontactsthematerial.Tighterspecificationsshouldbeconsideredforextractablesforfinalproductpurificationprocessmaterialsthanforfermentationmediaprocessmaterials.1.1Thisguidecoversproceduresandtestmethodsforprocesscomponentqualificationbytheenduser.Thegoalistoassessthesafetyimpactofextractablesfromnon-metallicprocesscomponentsusedincontactwithbioprocessingsolutions.Thisencompassestheimpactofextractablesonthesafetyofthefinalproductasitpassesthroughthevariousstagesofthemanufacturingprocess.Thisguideisnotdesignedforevaluationofmetallicmaterials,finalproductcontainer/closuresorthosecomponentsintentionallyaddedtotheproductorproductionstreamsduringthemanufacturingprocess.TestingofsolidsandextractsisspecifiedinotherASTMstandards.Materialsmustbequalifiedbyspecificuse.1.2ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.3Thereisnocompanionguideavailable.1.4Safety/Firehazards:ExtractionswithorganicsolventswillbeinfrequentunderthisGuide,but,whenusedmustbetreatedaspotentialfire/explosionhazards.1.5Thisguidedoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G04
【国际标准分类号】:07_080;07_100_10
【页数】:5P.;A4
【正文语种】: