定量小瓶加盖过程：残余密封力和容器封闭完整性.docxVIP

QuantifyingtheVialCappingProcess:ResidualSealForceandContainerClosureIntegrity

定量小瓶加盖过程：残余密封力和容器封闭完整性

ABSTRACT

Cappingcompletestheclosureofparenteraldrugproductsinthefinalpackagingcontainerandiscriticalinmaintaininganintegralsealtoensureproductquality.

Residualsealforce(RSF)isconsideredthesolequantifiableattributeformeasuringseal“goodness”andpotentiallyenablesnon-subjective,consistentsettingofcappersacrossmanufacturingsites.However,theconsistencyandreliabilityofRSFmeasurementanddatahavebeenscarcelyreported,andtherelationshipbetweenRSFandcontainerclosureintegrity(CCI)remainspoorlyunderstood.

轧盖完成了最终包装容器中非肠道药品的封闭，是保持整体密封以确保产品质量的关键。剩余密封力（RSF）被认为是测量密封“良好性”的唯一可量化属性，并可能能够在整个制造地点进行非主观的、一致的密封设置。然而，RSF测量和数据的一致性和可靠性很少被报道，RSF与容器封闭完整性（CCI）之间的关系仍不清楚。

Here,wepresentalargedatasetgeneratedfromacommercialcapperandtheresultsfromalaboratorycapperofglassvialsandrubberstopperswithaluminumcaps.AllRSFvaluesexhibitedsignificantvariability.Weevaluatedfourpotentialsourcesofvariability:thecapper,theRSFTester,thetimedependentnatureofRSF,andthecomponents.

Wedeterminedthatthecapper,theTester,andthetimedependentnaturearenotmainsources.Dimensionaltolerancesofthepackagingcomponentsweretherootcauseforthecontainerclosuresystem(CCS)configurationstestedinthisstudy.

在这里，我们展示了一个由商业封盖机产生的大型数据集，以及一个由玻璃瓶和带铝盖的橡胶塞组成的实验室封盖机的结果。

所有RSF值均表现出显著的变异性。我们评估了四个潜在的可变性来源：封口机、RSF测试器、RSF的时间依赖性以及组件。我们确定封口机、测试器和时间依赖性不是主要来源。

包装部件的尺寸公差是本研究中测试的容器封闭系统（CCS）配置的根本原因。

ThisstudycorrelatedRSFwithCCI(viaheliumleakage)althoughCCIisnotsensitivetoRSF;CCIwasmaintainedevenforlooselycappedvialswithnomeasurableRSF.Thiswasattributedtothestopper’stwosealingsurfaces:thevalvesealandthelandseal.

Amethodologycapableofdifferentiatingthetwoseals’functionsdemonstratedthatvialswithonlythevalvesealalwayspassedleakage