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Laboratory intercomparison for the evaluation of the delamination propensity of glass containers for pharmaceutical use
International Journal of Applied Glass Science ( IF 2.1 ) Pub Date : 2020-06-22 , DOI: 10.1111/ijag.15795
Massimo Guglielmi 1 , Nicola Bessegato 2 , Juan Cerdan‐Diaz 3 , Ken Choju 4 , Dave Lisman 3 , Carol Rea Flynn 5 , Emanuel Guadagnino 6 , Amy Meysner 7 , Joachim Pfeifer 8 , Holger Roehl 9 , Volker Rupertus 10 , Martina Scarpa 11 , Huimin Sun 12 , Jingwei Zhang 13 , Daniele Zuccato 2, 10
Affiliation  

This paper is the result of two round robin activities run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). It deals with the phenomenon of delamination, that is, the formation of lamellae or flakes in drug products due to specific and localized corrosion of glass vials, and it follows a first paper PDA J Pharm Sci Technol. 2018, 72, 553–565where a testing protocol for the evaluation of the delamination propensity was proposed. The results showed that the protocol gives information on the quality of vials with respect to the propensity to corrosion, but no direct correlation with delamination could be demonstrated, as no lamellae formation was observed.

中文翻译:

实验室比对,用于评估药用玻璃容器的分层倾向

本文是国际玻璃委员会(ICG)的TC12技术委员会(药品包装)进行的两次轮循活动的结果。它处理分层现象,即由于玻璃小瓶的特定和局部腐蚀而在药品中形成薄片或薄片,并遵循第一篇论文PDA J Pharm Sci Technol201872,553-565where对于脱层倾向评价的测试协议中提出的。结果表明,该协议提供了有关腐蚀倾向的小瓶质量信息,但由于未观察到薄片形成,因此未证明与分层有直接关系。
更新日期:2020-06-22
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