ASTM E3060-16美国材料与试验协会标准.pdfVIP

Designation:E3060−16

StandardGuidefor

SubvisibleParticleMeasurementinBiopharmaceutical

ManufacturingUsingDynamic(Flow)ImagingMicroscopy1

ThisstandardisissuedunderthefixeddesignationE3060;thenumberimmediatelyfollowingthedesignationindicatestheyearof

originaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.A

superscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.

1.Scopetialsourcesandcausesofparticlesduringbiomanufacturing.

1.1BiotherapeuticdrugsandvaccinesaresusceptibletoTheseresultscanbeusedtomonitortheseparticlesandwhere

inherentproteinaggregateformationwhichmaychangeoverpossible,toadjustthemanufacturingprocesstoavoidtheir

theproductshelflife.Intrinsicparticles,includingexcipients,formation.Thisguidewillalsoaddressthefundamental

siliconeoil,andotherparticlesfromtheprocess,container/principlesofdynamicimaginganalysisincludingimageanaly-

closures,equipmentordeliverydevices,andextrinsicparticlessismethods,samplepreparation,instrumentcalibrationand

whichoriginatefromsourcesoutsideofthecontainedprocess,verificationanddatareporting.

mayalsobepresent.Monitoringandidentifyingthesourceof1.4ThevaluesstatedinSIunitsaretoberegardedas

thesubvisibleparticlesthroughouttheproductlifecycle(fromstandard.Nootherunitsofmeasurementareincludedinthis

initialcharacterizationandformulationt