Suppr超能文献

时间-温度叠加评估及低温下容器密封系统密封性能建模。

Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures.

机构信息

West Pharmaceutical Services, Inc, Exton, PA 19341

West Pharmaceutical Services, Inc, Exton, PA 19341.

出版信息

PDA J Pharm Sci Technol. 2020 Jan-Feb;74(1):27-40. doi: 10.5731/pdajpst.2019.010371. Epub 2019 Jul 15.

Abstract

There has been a growing interest in the assessment of container closure systems (CCS) for cold storage and shipment. Prior publications have lacked systematic considerations for the impact of dynamic time temperature transition on sealing performance associated with the viscoelastic characteristics of rubber stoppers used in container closure systems (CCSs). This paper demonstrates that sealing performance changes inherently and is fundamentally both time- and temperature-dependent. Our research results display this critical time temperature transition impact on CCS sealing performance by applying compression stress relaxation (CSR) on a rubber stopper for experimental data collection and modeling evaluation. The experimental results agree with modeling evaluation following Maxwell-Wiechert theory and the time temperature superposition based on the Arrhenius and Williams-Landel-Ferry methods. Both testing and modeling data show good consistency, demonstrating that the sealing force inevitably changes over time together with temperature transition because of the viscoelastic nature of the rubber stoppers. Our results show that compression seal force decreases quickly as temperature decreases. The significant loss of rubber stopper sealing force at lower temperature transitions could contribute significant risk to CCI at low storage and transport temperatures. Modeling evaluation, with a powerful capability to handle actual testing data, can be employed as a predictive tool to evaluate the time- and temperature-dependent sealing force throughout the entire sealed drug product life span. The present study is only applicable before reaching the rubber glass transition temperature - a critical transition phase that can not be skipped/separated from real time temperature transition, and it will further determine the CCS sealing performance while approaching cryogenic temperature. The present work provides a new, integrated methodology framework and some fresh insights to the parenteral packaging industry for practically and proactively considering, designing, setting up, controlling, and managing stopper sealing performance throughout the entire sealed drug product life span.

摘要

人们对用于冷藏和运输的容器密封系统(CCS)的评估越来越感兴趣。先前的出版物缺乏对动态时间温度过渡对与容器密封系统(CCS)中使用的橡胶塞的粘弹性特性相关的密封性能的影响的系统考虑。本文通过在橡胶塞应用压缩应力松弛(CSR)进行实验数据收集和模型评估,证明了密封性能的固有变化,并且从根本上都是时间和温度相关的。我们的研究结果通过应用 Maxwell-Wiechert 理论和基于 Arrhenius 和 Williams-Landel-Ferry 方法的时温叠加原理对压缩应力松弛(CSR)进行实验数据收集和模型评估,展示了这种关键的时间-温度过渡对 CCS 密封性能的影响。实验结果与基于 Maxwell-Wiechert 理论和基于 Arrhenius 和 Williams-Landel-Ferry 方法的时温叠加原理的模型评估结果一致。测试和建模数据都显示出良好的一致性,表明由于橡胶塞的粘弹性,密封力不可避免地随时间和温度的变化而变化。我们的结果表明,随着温度的降低,压缩密封力会迅速下降。在较低的温度过渡下,橡胶塞密封力的显著损失可能会对低储存和运输温度下的 CCI 造成重大风险。具有强大处理实际测试数据能力的建模评估可以用作评估整个密封药物产品寿命期间时间和温度相关密封力的预测工具。本研究仅适用于达到橡胶玻璃化转变温度之前 - 这是一个关键的过渡阶段,不能从实际的温度过渡中跳过/分离,并且它将在接近低温时进一步确定 CCS 的密封性能。本工作为注射剂包装行业提供了一种新的、集成的方法框架和一些新的见解,以便在整个密封药物产品寿命期间实际和主动地考虑、设计、设置、控制和管理塞子的密封性能。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验