预灌封注射器组件密封性检查法公示稿（第三次）-英文2025中国药典公示稿

2024年7月

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4041ExaminationMethodofSealabilityforComponentsofPrefilledSyringes

Thismethodconsistsofexaminationmethodforsealabilitybetweentipcap/needleshieldand

barrelandexaminationmethodforsealabilitybetweenplungerstopperandbarrelofprefilled

syringes.

Method1:Sealabilitybetweentipcap/needleshieldandbarrel

Thismethodisusedtodeterminetheliquidleakageresistanceofthefitnessbetweentip

cap/needleshieldandtheneedleendorLuerconnectorofthebarrelofaprefilledsyringes.

Instruments

PressureApplicationDevice.Tensiletestingmachineorpressuredevicethroughthe

applicationofcompressedair.

Note:Applicationofpressureviatensiletestingmachine(seeFig.1a)canbeusedwhenwall

frictioncanbeneglected[whenapplyingthecalculatingtestforceaccordingtoequation(1),the

internalpressureofthesyringecanbeabove95%ofthetargetpressure.],.Ifwallfrictioncannot

beneglected,preferenceisgiventothetestasinFig.1b,wherethepressureisappliedonthetip

cap/needleshieldthroughtheapplicationofcompressedaironthefilledmedia.

Syringeholder.

Plungerstopperandplungerrod.

Samplepreparation

Theretentiontimebetweensamplesettingandleaktightnesstestshallbeatleast12h.Donot

damageorloosenthetipcap/needleshieldpriortotesting.

ExaminationMethod

Methoda：Insertthetestsampleintotheholder(seeFig.1a).Fillthetestsampleto

between1/3and1/2ofthenominalvolumewithwater.Assembletheplungerstopperandtherod,

putthemintothebarrel.Applyapressurewhichiscalculatedfromequation(1)totherodtomake

theinternalpressureofthebarrel110kPa.Andholdthepressurefor5s.Examinewhetherthetip

cap/needleshieldhasfallenoffandtheleakageduringandafterthetest.

Thecorrelationbetweenthetestforceandthecross-sectionalareaofthesyringethatis

determinedbythenominalinnerdiameterofthesyringecanbecalculatedusingFormula(1)to

(3).

30 𝐹=𝑝×𝐴 （1）

31 and

32

33 follows

34

𝐴=

π

π×𝑑

4

2

2 （2）

−3

35 Where

36

Fisthetestforce,N;

𝐹=𝑝×

4

×𝑑

×10

（3）

Pisthetargetinternalpressure,kPa(i.e.110kPa);

Aisthecrosssectionalareaofthesyringebarrel,mm2;

disthenominalinnerdiameterofthesyringebarrel,mm.

40

a.Pressureappliedthroughplungerrodandplungerstopper

b.Pressureisappliedonthefilledmediathroughtheapplicationofcompressedair

Fig.1 Examplesoftestingdevicesforthedeterminationofliquidleaktightnessbetweentip

cap/needleshieldandthebarrel

1.Syringeholder；2.Syringewithtipcap/needleshield；3.plungerrodandplungerstopper

Note：Thisillustrationuseasyringewithaneedleshieldasanexample.Thetestingisequally

applicabletosyringeswithatipcap.

Methodb：Insertthetestsampleintotheholder(seeFig.1b).Fillthetestsampletobetween1/3

and1/2ofthenominalvolumewithwater.Closetheendofthesyringe,andleaveapressuring

passage.Applyapressureof110kPatothesyringeandholdthepressurefor5s.Determine

whetherthetipcap/needleshieldhasfallenoffandtheleakageduringandafterthetest.

Method2:Sealabilitybetweenplungerstopperandbarrel

Thismethodisusedtoexaminetheliquidleakageresistanceofthefitnessbetweenthe

plungerstopperandthebarrelofaprefilledsyringewhenforceisappliedtotheplungerrod.

Instruments

Deviceforapplyingasidewaysforcetothesyringeplungerrod,intherangeof0.25Nto3N.

Deviceforgeneratingpressuresof200kPaand300kPaaxialtothebarreland/orplungerrod.

ExaminationMethod

Drawintothesyringeavolumeofwaterexceedingthenominalcapacityoftheprefilled

syringe.Expelairandadjustthevolumeofwaterinthesyringetothenominalcapacity.Connect

thetip/needletubingtothepressuregageandsealthesyringenozzle.Applyasidewaysforceto

thepushbuttonatrightanglestotheplungerrodwithaforceasgiveninTab.1.Orientatethe

plungerrodtopermitthemaximumdeflectionfromtheaxialposition.Applyanaxialforcetothe

syringesothatthepressuregiveninTable1isgeneratedbyrelativeactionoftheplungerstopper

0

andbarrel.Maintainthepressurefor（30+5）s.Examinethesyringeforliquidleakagepastthe

plungerstopper,liquidbetweentheribsispermitted.

Tab.1 TestvaluesforleaktightnessbetweenplungerstopperandbarreloftheSyringe

Nominalcapacityofsyringe

ml

Side