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1、TheStatefoodandDrugAdministrationNationaldrugpackagingcontainers(material)standard(interim)YBB001020053-layerCo-extrusionFilmsandBagsUsedforInfusionPolypropyrene/polypropyrene/polypropyrenethree-tierfilmreferstopolypropyreneasthemainbodytoadoptthecoextrusionprocess,donotuseadhesive,forme
2、dbythethree-tierIVfilm.Bagsismadeofpolypropyrene/polypropyrene/polypropyrenethree-tierIVfilmbyrahfuusedforinfusion.[Appearance]regulationsappearanceanadequateamountoflightinthenatureoftherink,theDepartmentshouldbeaddressedinatransparentandsmooth,non-visibleforeignmatter.[Identification]*
3、(1)Microscopiccharacteristicsofthisproductbyjusttherightamount,andcutintoappropriatethicknessismicroscopically,crosssectionshoulddisplayaclearthirdfloor.(2)TheproductisInfraredSpectratakeninmoderation,withthethicknessoftheslicercutintocolussoma(lessthan50μm)adjustableplate,situatedatamic
4、ro-infraredinstrumentobservationsamplecrosssection.Accordingtothepackagingmaterialinfraredspectrometry(YBB00262004)methodforthedetermination,eachlayershouldbesubstantialagreementandelectrophoretograms.[Sterilizaionadaptabilityofbags]exceptwhereotherwiseprovided,theproductisanumber,andby0
5、.45μmporesizefiltrationofwaterforinjectiontonongraphitecapacity,andseal.Usethemethodofsterilization(standardsterilizaionF0value=8,suchassterilizationof121℃for15minutes)tosterilizaion,makethefollowingexperiment:Temperatureadaptabilitysaidsamplesor25℃±2℃,placedundertheconditionofa24-hour,a
6、ndtheninthe50℃±2℃tocontinuetobeplacedunder24hours,andthenonthe23℃±2℃,placedunder24hours,thesampleisplacedbetweentwoparallelplates,67KPaofhyperteution,themaintenanceofupto10minutes.Shouldhavenoliquid.Resistancetodropthesaidsamplesor25℃±2℃,placedundertheconditionofa24-hour,andtheninthe50℃±
7、2℃tocontinuetobeplacedunder24hours,andthenonthe23℃±2℃in24hourswillbeplacedinthecondition,accordingtotable1dropdropheight,respectively,inastereoplasmonrigidsmoothsurfacewithoutruptureandleak.Table1dropheightnongraphitecapacity(ml)dropheight(m)50~7491.00750~14990.751500~249
