药品包装用塑料包装系统及组件指导原则公示稿（英文版）2025中国药典公示稿

July2024

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9624Guidelineforplasticpackagingsystemandcomponentsforpharmaceutical

packaging

Thisguidelineappliestoplasticpackagingsystemandcomponentsforcontactingdirectlypharmaceutical

packaging.Forplasticcomponentsthatcontactindirectlywithpharmaceuticalpreparationsbutprovide

additionalprotectionordeliveryforpharmaceuticalpreparations,theguidelinecanserveasreference.

Classifiedbymaterial:Commonmaterialsusedforplasticpackagingsystemandcomponentsinclude

polyethylene(PE),polypropylene(PP),polyethyleneterephthalate(PET),polycarbonate(PC),cyclic

polyolefin(COC,COP,etc.),polyvinylchloride(PVC),polyvinylidenechloride(PVDC),ethylvinyl

acetate(EVA),polyamide(nylonPA);Polyoxymethylene(POM)andthecompositematerialsmadeof

abovematerialsbycompositing.

Classifiedbythepharmaceuticaldeliveryroute:plasticpackagingsystemandcomponentsforinjections,

forinalationaerosolsandsprays,fortopicalpreparations(eyepreparations,auralpreparations,nasal

preparations,externalpreparation,etc.),fororalpreparations,etc.

Classificationbydose:Single-dosepackagingsystemforsingledose,andmultiple-dosepackagingsystem

forabovesingledose.

1TermsandDefinitions

PlasticAbbreviationforplasticpolymermaterials.Itreferstoprocessedandmoldedplasticmaterialsor

cross-linkingcuringmaterials,withmaincomponentofsyntheticresinwithhighmolecularweight,added

byappropriateadditives,suchasplasticizer,stabilizer,antioxidant,lubricantandcolorant.

PelletBroadlyspeaking,itisarawmaterialforprocessingplasticproducts,andgranularcompoundmade

ofhighmolecularweightpolymers(resin),generallywiththemeltedtemperaturerangeandsoften

temperaturerangeafterheating.Ithasuniquenumber,suchasgradenumber,clearscopeofapplication,

certainmolecularweightrange,meltingindex,etc.

PlasticComponentAnyplasticcomponent(orpredominantlyplasticcomponent)usedinthe

pharmaceuticalpackagingsystem,includingplasticcontainers,andproductswhichareshapedthrougha

plasticizingprocess.

PlasticContainerContainersmanufacturedbyplastic(orpredominantlyplastic)tocontain

pharmaceuticalpreparation.

PlasticPackagingsystemPackagingsystemcomposedofplasticpackagingcomponents.

TypeSampleProductsproducedwithcertainformulaandstablyprocessesevaluatedtomeettheuse

requirements.Itisinaccordancewiththemass-producedformula,processesandpurposes.

2Basicrequirements

2.1Productionrequirements

2.1.1PlasticPackagingsystemandcomponentsforpackagingdrugsshallbemanufacturedinaccordance

withrelevantproductionqualityspecifications.

2.1.2Whenselectingplasticpellets,thesafetyrisksofpelletsandadditivesshouldbeevaluated,suchas

thetypeandmaximumusageofadditives,monomerresidue,metalresidueandtestresultsofrelated

extractablematters.Thetypeandresidueofadhesivesandsolventsinthecompositematerialshallbe

controlled.

2.2Userequirements

2.2.1Theplasticcomponentsselectedforpharmaceuticalpreparationsshallhavegoodcompatibilitywith

thepackaging,andmustnotaffectthequality,safetyandeffectivenessofthepharmaceuticalpreparations.

2.2.2Whenadoptingplasticpackagingcontainersandcomponents,thebarrierpropertiesshallbe

investigatedaccordingtothequalityrequirementsofthedrugspackagedincombinationwithdifferent

materials,processingtechnologies,materialthickness,packagingspecificationsandshelflife,andbe

evaluatedforthecompliancewiththeneedsofdrugsaccordingtothequalityrequirementsof

pharmaceuticalpreparations.

2.2.3Theattentionshallbepaidtotheimpactoftheprocessonthematerial,andthetestitemsandlimit

requirementsshallbeestablished.Forexample,theresidueofthesterilizingagentanddegradation

productsshallbecontrolledduringchemicalsterilization.

2.2.4Whentheplasticcomponentsarecombinedorusedwithcomponentsmadeofothermaterials,they

shallhavegoodfitnessandshallnotaffectthesealingpropertiesofthepackagingsystem.Whennecessary,

anappropriatemethodshallbeselectedforevaluationaccordingtothepharmaceuticalriskassessmentand

theGuidelinesforsealingpropertiesofpharmaceuticalpackagingsystems(Guideline9628).Forsome

plasticcomponentswhichareeasilysoftenedbyheatandbrittlebysupercoolingatdifferenttemperatures

andwillswellandeasytodeformundertheactionofsolventsinsomepreparationformulas,theattention

shallbepaidtotheimpactofmaterialchangesontheintegritywhenbeingusedfortheintendedpurpose

understorageconditions.

2.2.5Plasticcomponentsforpharmaceuticalpackagingofdifferentmaterialsandpurposesshouldbe

evaluatedortestedforthebiologicalsafetyinaccordancewiththeGuidlinesforbiologicalevaluationand

testselectionofpharmaceuticalpackagingmaterials(Guideline9651).

2.2.6Themicrobialcontrolstrategyshouldbeestablishedbasedonriskmanagement.ThePlastic

Packagingsystemandcomponentsfordrugspackagingindifferentsupplyformsshouldbeconductedwith

theinspectionofthesterility,bio-burdenlimitormicrobiallimitinaccordancewiththeGuidelinesfor

microbiologicaltestingofpharmaceuticalpackagingmaterials(Guideline9653)andconductedwiththe

bacterialendotoxintestinaccordancewiththeGuidelineforBacterialEndotoxinTestMethodApplication

(Guideline9251).

3Productqualitycontrol

Inordertoensurethequalitycontrolofdrugs,meettheclinicalneedsandusesafety,themanufacturers

andusersofPlasticPackagingsystemandcomponentsfordrugspackagingshallcomplywiththe

enterprisespecificationorqualityagreementsforproductsbasedontheactualproductionandusesituation

inaccordancewithbutnotlimitedtotherequirementsofthebodyoftheguidelineandannexes1to8.The

qualitycontrolrequirementsforsteriledrugpackagingsystemsusingBlowFillSealing(BFS)technology

canrefertoannex9.

3.1Identification

Usedtoidentifythematerialofplastic.Incaseofanychangeoftherawmaterialsupplierandproduction

technologiesofplasticcomponentsfordrugspackagingoranyqualityproblemofproducts,the

appropriateidentificationtestshouldbeconducted.Inadditiontothefollowingmethods,thedifferential

scanningcalorimetry(DSC)maybeadoptedwhennecessary.

Infraredradiation(IR)Accordingtothetestingofinfraredspectroscopymethodforpackagingmaterials

<4002>,theobtainedspectrumshouldbeconsistentwiththatoftypicalsample.

DensityThedensityshallbedeterminedinaccordancewithDensityDeterminationMethodfor

pharmaceuticalPackaging<4012>andshallcomplywiththeenterprisespecificationorquality

agreements.

3.2Extractablestest

Theextractablestestisusedtoevaluatethetotalextractablematterandspecificextractablematterinthe

plasticcomponentsforpharmaceuticalpackagingandcanbeusedforthepreliminaryriskassessmentof

productsandtomonitorthestabilityofproductquality,andtocontrolthepossibleimpactofcontainers

andcomponentsindirectcontactwithdrugsonpharmaceuticalpreparationsquality.Thesupplierandthe

demandershouldselectappropriateextractablestestitemsforcontrolinaccordancewiththe

DeterminationofExtractablesforPharmaceuticalPackagingMaterialsandContainers<4204>,according

totheriskdegreeandcompatibilitystudyresultsofthepackageddrugs,incombinationwithdifferent

materialsandprocessingtechnologies.Theextractablecontrolrequirementsofseveralcategoriesofplastic

containersandcomponentscommonlyusedareshowintable1-3.Fortheapplicablescopeofvarious

products,pleaserefertothegeneralchaptersofeachcategory.Forcategoriesandmaterialsnotlisted,

pleaserefertoandnotlimitedtothefollowing.

Inadditiontotheitemsinthetablebelow,fortheinspectionofelementalimpurities,alsoreferto

GuidelineforElementalImpurities(Q3D).Identifyknownorpotentialsourcesofelementalimpurities

accordingtomaterialsandproductiontechnologiesofdifferentproducts,carryouttheriskassessmentof

elementalimpuritiesincombinationwiththepharmaceuticalpreparationqualityrequirements,determine

theimpuritiesaspertheassessmentresultsandinaccordancewiththeElementalImpurityDetermination

MethodforPharmaceuticalPackaging<4214>whenapplicable,andformulatethecontrolrequirementsin

theenterprisespecificationorqualityagreements.

Thenonvolatilemattersshallbecontrolledincombinationwiththeexpectedcharacteristicsandrisk

degreeofpackagedpharmaceuticalpreparations.Whenapplicable,thetestsolutionshallbepreparedwith

appropriatemethodaccordingtotheDeterminationofExtractablesforPharmaceuticalPackaging

MaterialsandContainers<4204>todeterminethenonvolatilematters,whichshallcomplywiththe

enterprisespecificationorqualityagreements.

Table1extractablestest(plasticproductsforinjectionsandeyedrops)

Productcategory

Testitems

Plastic packaging components forinjections

Plasticcontainersandcapsforeyedrops

Preparation of test

Regularsampleb:GeneralChapter

Bottle:MethodV

solution

4204MethodI

Irregularsample:GeneralChapter4204MethodIII

Nozzleandcap:MethodVI

Clarity

Thetestsolutionshouldbeclear;ifitisturbid,itshallnotbethickerwhencomparedwithNo.2standardturbidity

liquid

Thetestsolutionshouldbeclear;ifitisturbid,itshouldnotbethickerwhencomparedwithNo.2standard

turbidityliquid

Color

Colorless

/

pHorpHvariation

5.0-7.0(pH)

Nomorethan1.0(pHvariation)

Ultravioletabsorbancea

220-240nm:Nomorethan0.08241-350nm:Nomorethan0.05

220~350nm:Nomorethan0.10

Reducingsubstances(volumedifferencewhenconsuming0.01mol/Lsodiumthiosulfatetitration

solution)

Nomorethan1.5ml

Nomorethan1.5ml

a:Itissuitableforpolyolefinmaterials,suchaspolyethyleneandpolypropylene,andothermaterialsshall

complywithenterprisespecificationorqualityagreements.

b:Easytoobtainflatpartsandsurfaceareaofthesample,suchasbottles,bags,etc.

Table2extractablestest(plasticproductsfortopicalliquidpreparationsandointments)

Product

category

Testitems

Plasticcompositetubesandcomponents(tubeshouldersandcaps)fortopicalointments

Plasticbottlesandcapsfortopicalliquidpreparations

Preparationoftestsolution

Tubebody:GeneralChapter4204MethodVII

Tubeshoulder/cap:GeneralChapter4204MethodVIII(ifnecessary,eachshoulder/capcanbecrosslycutintofourparts)

Bottle:GeneralChapter4204MethodVII

Cap:GeneralChapter4204MethodVIII(ifthecapisacombinedstructure,takethepartthatiscontactwiththeliquidpreparation;ifnecessary,each

capcanbecrosslycutintofourparts)

Clarity

/

Clear;ifitisturbid,itshallnotbethickerwhencomparedwithNo.2

standardturbidityliquid

pH variation no

morethan

/

Nomorethan1.0

Ultraviolet

absorbance(220-350nm)

Nomorethan0.10

Watertestsolution:Nomorethan0.1

50%ethanoltestsolutiona:Nomorethan0.2

Reducingsubstances

(volumedifferencewhenconsuming0.01mol/Lsodiumthiosulfatetitrationsolution)

Nomorethan1.0ml

Nomorethan1.5ml

a:Itissuitableforbottlescontainingliquidpreparationsmadeofethanolasasolvent,amongwhich,

polyesterbottlesshallcomplywiththeenterprisespecificationorqualityagreements.

Table3extractablestest(plasticproductsfororalpreparations)

Product

category

Testitems

Plasticbottlesandcapsfororalliquidpreparations

Plasticbottlesandcapsfororalliquidpreparations

Compositefilmsandbagsfororalsolidpreparations

Sheetsfororalsolidpreparations

Preparationoftestsolution

Bottle:General

Chapter 4204MethodVII

Cap: GeneralChapter 4204MethodVIII(ifthecapisacombinedstructure,takethepartthatiscontactwiththeliquidpreparation; ifnecessary,eachcapcanbecrosslycut

intofourparts)

Bottle:GeneralChapter4204MethodVIICap:GeneralChapter4204

MethodVIII(ifthecapisacombinedstructure,takethepartthatiscontactwiththesolidpreparation;ifnecessary,eachcapcanbecrosslycut

intofourparts)

GeneralChapter4204MethodIX

GeneralChapter 4204MethodX

Clarity

Clear;ifitisturbid,itshouldnotbethicker when

comparedwithNo.

/

/

/

2standardturbidity

liquid

pHvariation

Nomorethan1.0

/

/

/

Ultravioletabsorbance

,220-360nm

Nomorethan0.1

/

/

/

Reducingsubstances(volumedifference whenconsuming0.01mol/Lsodiumthiosulfate

titrationsolution)

Nomorethan1.5ml

No more than1.5ml

Nomorethan1.5ml

Nomorethan1.5ml

Annex1:Plasticpackagingsystemandcomponentsforinjections

Thisannexappliestoplasticpackagingsystemandcomponentscontactwithinjection,concentrated

solutionforinjection,etc.,whichareproducedbyplasticmoldingprocesswithplasticpelletsasthemain

rawmaterial.Thisannexisnotapplicabletothemulti-chamberinjectionpackagingsystems.Packaging

systemsforrinsingpreparationscanrefertoimplementation.Thequalitycontrolrequirementsforthe

plasticpackagingsystemforinjectionusingBlowFillSealing(BFS)technologycanrefertoAnnex9.

Classifiedbytheshapeandstructureofcontainers,plasticcontainersforinjectionsaredividedinto:plastic

ampoules,plasticbottles,plasticbags,etc.

Classifiedbyshapeandstructure,plasticcomponentsforinjectionsaredividedintosealedcaps,interfaces,

hoses,etc.

Classifiedbypackageddrugdose:ASingle-dosecontainerisdesignedforusewithasinglepatientasa

singleinjection/infusion.AMultiple-dosecontainerisintendedtocontainmorethanonedoseofadrug

product.

Plasticpackagingsystemforinjectionsshallcomplywiththerequirementsofthebodyoftheguideline

andthefollowingrequirements.

TheproductionmanagementandqualitycontrolofPlasticpackagingsystemandcomponentsfor

injectionsshallcomplywiththerequirementsoftherelevantqualityspecification.Theproduction

environmentshouldbecontrolledinaccordancewiththeGoodManufacturingPracticeforDrugs.When

selectingthematerialofplasticpackagingsystemandcomponentsforinjections,thesafetyrisksof

materialsandadditivesshouldbeevaluated,suchasthetypeandmaximumusageofadditives,monomer

residueandelementalimpurities.Thepackagingsystemsforinjectionsshouldbeconductedwiththe

integrityevaluationinalllinksofproductdesign,processverification,commercialproduction,andproduct

stabilityinvestigationinaccordancewithGuidelinefortheIntegrityofSterilePharmaceuticalPackaging

System(Guideline9628).Atthesametime,anappropriatesamplingschemeshouldbeselectedbasedon

theresultsofriskassessmenttoformulatetheenterprisespecification.

Plasticpackageforinjectionsarehigh-riskpreparationsandthesectorofusingshouldfurthercarryout

relevantevaluationandcontrolbasedontheprincipleofriskassessment.1.Theinfluencesofthe

connectionwaysbetweencomponentsontheintegrityofpackagingsystemsshouldbeevaluated.2.Ifthe

specificationandshapehaveanimpactontheprotectionandfunction,itshouldbeevaluated.When

necessary,adiagramshouldbeestablishedtoclarifythecontrolrequirements.Iftherearefunctional

componentsforimprovingtheprotectionandfunctioninthepackagingsystems,relevantperformance

controlitemsandrequirementsshouldbeestablished.3.Appropriatemethodsshouldbeusedtoinvestigate

theimpactofthetransportationandstorageprocessesontheintegrityofthepackagingsystemsfor

injections,includingbutnotlimitedtothequalitytestitemsofpackageintegrity,suchaheatsealstrength,

dropresistanceandleakagerate.4.Whentherearespecialrequirementsforthepreparationsandother

volatileingredientsneedtobeaddedtotheformulationandprocess,furtherattentionshouldbepaidtothe

requirementsforthebarrierpropertyofthepackagingsystemsforinjections.Outerpackaging(secondary

packaging)bagswithhighbarrierpropertyshouldbeusedifnecessary.Theevaluationitemsandlimit

requirementsforthebarrierbags,suchasoxygentransmission,nitrogentransmissionorcarbondioxide

transmission,shouldbeaddedtotheenterprisespecificationincombinationwiththeformulationand

processcharacteristicsofthepreparations.5.Therequirementsforclinicaluseshouldsetitemsand

requirementsaccordingtothecharacteristicsandstructuralformsofpackagingsystems,aswellasthe

usageintheinstructions.6.Ifnecessary,thespecificextractsobtainedfromextractablematterresearch

shouldbecontrolledintheenterprisespecificationorqualityagreementsbasedontheresearchresultsof

extractablematters,whichshallcomplywiththeenterprisespecificationorqualityagreements.

1Microbiologicalcontrol

Ifapplicable,thebioburdenshallbedeterminedinaccordancewiththeGuidelineforMicrobiologicalTest

ofPharmaceuticalPackaging(Guideline9627)andshallcomplywiththeenterprisespecificationor

qualityagreements.

Ifapplicable,thetestshallbedeterminedinaccordancewiththesterilitytestmethodintheGuidelinefor

MicrobiologicalTestofPharmaceuticalPackaging(Guideline9627)andshallcomplywiththeenterprise

specificationorqualityagreements.

2Bacterialendotoxin

Ifapplicable,refertotheGuidelineforBacterialEndotoxinTestMethodApplication(Guideline9251)and

shallcomplywithenterprisespecification.

3Physicalproperties

Theattentionshouldbepaidtospectraltransmission,watervaportransmission,gaspermeance,

mechanicalproperties,etc.Ifapplicable,relevantitemsshallbeestablishedintheenterprisespecification

orqualityagreements,whichshouldbetestedandcomplywiththeenterprisespecificationorquality

agreements.

4Insolubleparticles

ThesampleshallbedeterminedaccordingtothemethodfortheDeterminationofParticulateMatterfor

PharmaceuticalPackagingMaterialsandContainers<4206>,whichshallcomplywiththeenterprise

specificationorqualityagreements.

5Useperformance

5.1Inaccordancewiththeclinicalusewaysofinfusionbagsandbottles,theattentionshouldbepaidto

clinicaluseperformanceitems:Penetrationforce,fragmentation,puncturedeviceretentionandinsertion

pointimpermeability,injectionpointairtightness,suspensionforce(forsuspensionfunction),drop

resistanceandopeningforce.Ifapplicable,relevantitemsshouldbeestablishedintheenterprise

specification,whichshouldbetestedandcomplywiththeenterprisespecification.

5.2Plasticampoulesshouldbesetupopeningforceitem,accordingtothemethodspecifiedinthe

enterprisespecification,andshouldcomplywiththerelevantrequirements.Attentionshouldbepaidto

watervaportransmissionandspectraltransmissionitemsforthesecondarypackaging,whichshouldmeet

theenterprisespecification.

5.3RefertothefunctionalrequirementsofGuidelineonRubberClosuresforPackagingInjections

(Guideline9623)ifthepackagingwithrubberclosuresforinjectionsisapplicable.Packagingsystemcan

alsobetestedcombinedwiththecharacteristicsaccordingtothemethodsspecifiedintheenterprise

specificationorqualityagreements,andshouldcomplywiththeenterprisespecificationorquality

agreements.

5.4Forthepackagingsystemswithspecialuserequirements(suchasclosedinfusion),theattentionshould

bepaidtoitemsthatmayaffecttheclinicaluse,suchastheresidualvolumeandevacuationtime.If

applicable,relevantitemsshouldbeestablishedintheenterprisespecification,whichshouldbetestedand

complywiththeenterprisespecification.

5.5Formultiple-dosepackagingsystems,theattentionshouldbepaidtoitemsthatmayaffecttheclinical

use,suchasthesealabilityformultipleuseanddoseaccuracy.Ifapplicable,relevantitemsshouldbe

establishedintheenterprisespecification,whichshouldbetestedandcomplywiththeenterprise

specification.

201

Annex2:PlasticBottlesystemandComponentsforEyedrops

Thisannexappliestomoldedplasticbottlesandcomponentswhosebodyaremadeoflow-density

polyethyleneorpolypropyleneforeyedrops.

Intermsofbottlematerial:itcanbeclassifiedaslow-densitypolyethylenebottlesforeyedrops,and

polypropylenebottlesforeyedrops.

Intermsofthedosageofeyedrops:itcanbeclassifiedasplasticbottlesforsingle-doseeyedrops,and

plasticbottlesformultiple-doseeyedrops.

Itisadvisablethatbottlebody,bottlenozzle,andbottlecapbepackagedseparatelyandstoredinadryand

cleanplace.Thepackagingofsterileproductsshallcomplywiththerequirementsforsterilization,physical

protection,maintenanceofsterilitystatebeforeuse,andsterileaccess.

Theplasticbottlesystemandcomponentsforeyedropsshouldcomplywiththerequirementsofthemain

bodyofthisguideline,andmeetthefollowingproductqualitycontrolrequirements.

1Generalrequirements

Withthepurposeofensuringthecontrollablequalityofdrugs,meetingclinicalneedsandsafetyinuse,

manufacturersandusersofplasticbottlesandcomponentsforeyedropsshalldeveloptheenterprise

specificationorqualityagreements.Drugproductmanufacturersshallpayattentiontoanychangeofthe

functionalexcipients(e.g.,antimicrobialpreservatives,etc.)intheformulaoftheirdrugproductsduring

compatibilitystudiesandbarrierpropertyevaluations.

Theappearance,spectraltransmission,residueonignitionandmicrobiologicalcontrolmaybecontrolled

accordingtotherequirementsofproductqualitybetweenthemanufacturersandusers,aswellasthe

resultsofriskassessment,andshallcomplywiththeenterprisespecificationorqualityagreements.

Bottlecapswithadditionalfunctions,suchasbacterialbarriercapsandtamper-evidentcaps,shallbe

assessedfortheperformanceoftheiradditionalfunctions,whichshallcomplywiththerequirementsofthe

enterprisespecificationorqualityagreements.

2Decolourizationtest

Applicabletocolourbottle.CarryouttheDecolourizationExaminationMethodforPlastics<4205>,any

colourproducedwiththetestsolutionisnotmoreintensethanthatoftheblanksolution.

3Non-volatilematterinn-hexane

Applicabletobottle.Cut5.0gofthebottleintosmallpiecesofsuitablesize(eg.3cm×0.3cm)andplace

theminaround-bottomflask.Addaccurately50mlofn-hexaneandboilunderrefluxconditionsfor4

hours.Allowtocooldowninanicewaterbathandfiltertheextractingsolution.Transferthefiltrateinto

anevaporatingdishpreviouslydriedtoconstantweight,evaporatetodrynessonawaterbathanddryat

105℃for2hours,thenweigh.Performablankdeterminationandmakeanynecessarycorrection.Thetest

resultshallcomplywiththerequirementsoftheenterprisespecificationorqualityagreements.

4Assemblingperformance

4.1Compatibility

Applicabletoassessmentofthecompatibilitybetweenthebottleandbottlecapforbottleswithscrewcaps.

Assemblethebottle,bottlecap,bottlenozzle(ifany)andscrewtightlyaccordingtotherequirements

specifiedintheenterprisespecificationorqualityagreementsand,nostrippedscrewisallowed.

4.2Sealabilitybetweencomponents

Applicabletonon-BFS(blowing-filling-sealing)bottlesforeyedrops.Assemblethebottlebody,bottlecap,

andbottlenozzle(ifany)andsealaccordingtotherequirementsspecifiedintheenterprisespecificationor

qualityagreements.Placetheassembledbottleinacontainerwithanevacuationdevice,mountthe

partitionplates,addwatertoimmersethebottle(glassbeadscanbepreviouslyaddedtothebottleorother

suitablemethodscanbeused).Evacuatethecontainertoachieveavacuityof20kPaandmaintainfor2

minutes,nowateringressionorcontinuousbubblingisallowed.

4.3Watervaportransmission

Assemblethebottle,bottlecap,andbottlenozzle(ifany)accordingtotherequirementsspecifiedinthe

enterprisespecificationorqualityagreements.TestaccordingtotheDeterminationofWaterVapor

TransmissionofPackagingMaterialsorContainersforPharmaceuticalUse.(seethefirstmethod,

gravimetricmethod,inGeneralChapter4010,2weightlossmethod,testconditionB).Andtheresultshall

complywiththeenterprisespecificationorqualityagreements.

AsforBFSbottlesforeyedrops,makesamplesprefilledwithlabelledquantityofwaterordrugs.Test

accordingtotheDeterminationofWaterVaporTransmissionofPackagingMaterialsorContainersfor

PharmaceuticalUse(seethefirstmethod,gravimetricmethod,inGeneralChapter4010,2weightloss

method,testconditionB).Andtheresultshallcomplywiththeenterprisespecificationorquality

agreements.

5Visibleparticles

Applicabletonon-BFSbottlestobesterilized.Fillthebottlewith0.9%sodiumchlorideinjectionor

injectionwatertolabelledquantity,thenassemblethebottle,bottlecap,andbottlenozzle(ifany)andseal

accordingtotherequirementsspecifiedintheenterprisespecificationorqualityagreements.Shakefor1

minutesandexamineaccordingtotheTestforVisibleParticles<0904>.Andtheresultshallcomplywith

theenterprisespecificationorqualityagreements.

6Dropvolume

Applicabletoplasticbottlesformulti-doseeyedrops.BFSbottlesformulti-doseeyedropsshallbeopened

accordingtothemethodspecifiedintheenterprisespecificationorqualityagreementsbeforetest.Fillthe

bottlewith0.9%sodiumchloridesolutiontolabelledquantity.Ifthereisabottlenozzle,itshallbe

combinedaccordingtotherequirementsspecifiedintheenterprisespecificationorqualityagreements.

Wipedrythebottlemouth.Discardafewdropsfirstlytoavoidtheinfluenceofbubbles.Thencollect50

dropsofthesolution(10drops/min)andobtainaccurateweight(m).Calculatethemeandropvolume(V)

bythefollowingexpression.Theresultsshallcomplywiththeenterprisespecificationorquality

agreements.

274

where Visthemeandropvolume,ml;

misthemassofdrippedsolution,g;

ρisthedensityof0.9%sodiumchloridesolution,calculatedas1.0g/ml.

Note:Itisacceptabletoreducethenumberofdropstobecollectedforsmallvolumeplasticbottlesforeye

drops,inthatcase,replace50intheexpressionwiththecorrespondingnumberofcollecteddrops.

7Residualethylene