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注射用小瓶容器/密封完整性的定量和机理测量。泄漏定量。

Quantitative and mechanistic measurements of parenteral vial container/closure integrity. Leakage quantitation.

作者信息

Morton D K, Lordi N G, Ambrosio T J

出版信息

J Parenter Sci Technol. 1989 Mar-Apr;43(2):88-97.

PMID:2709241
Abstract

Leakage across the parenteral vial/closure seal interface is quantitatively measured in terms of mass of gas per unit time using a differential pressure method of leakage measurement. With this test system, uncoated, Purcoat coated, and film coated closures are compared for their ability to seal nondefective and defective vial surfaces. Correlations are made between closure sealing performance and rubber viscoelasticity, closure coating material type and thickness, and crimped vial residual seal force.

摘要

采用差压法测量泄漏量,以单位时间内气体的质量来定量测定通过非肠道药瓶/密封件密封界面的泄漏情况。利用该测试系统,对未涂层、Purcoat涂层和薄膜涂层的密封件在密封无缺陷和有缺陷药瓶表面的能力方面进行比较。并对密封件的密封性能与橡胶粘弹性、密封件涂层材料类型和厚度以及压接药瓶的残余密封力之间的关系进行了研究。

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