开发一种概率模型,以预测缩瓶密封件的剩余密封力
DanaLouise Cabrita1, George Currier2, Anthony Petrella3
1Drug Product Development, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08901 Dana.Cabrita@bms.com Cabrita.Dana@gmail.com.
PDA journal of pharmaceutical science and technology
|December 16, 2025
概括
容器封闭完整性 (CCI) 对于无菌包装至关重要. 这项研究开发了一种有限元模型,用于预测瓶子系统中的剩余密封力 (RSF),发现塞尺寸显著影响密封力.
科学领域:
- 药品包装 药品包装 药品包装
- 材料科学 材料科学 材料科学
- 机械工程 机械工程
背景情况:
- 容器封闭完整性 (CCI) 对无菌药品包装至关重要.
- 基于瓶子的容器封闭系统 (CCS) 依赖于瓶子,堵塞和结密封的相互作用.
- 组件尺寸和老化效应的变量可能会影响CCS性能.
研究的目的:
- 开发一种确定性有限元模型,用于预测固定位移结系统中的剩余密封力 (RSF).
- 调查组件尺寸和老化对RSF的影响及其与CCI的相关性.
- 确定密封力大小和瓶盖过程中变化的关键驱动因素.
主要方法:
- 开发了用于RSF预测的确定性有限元模型.
- 进行概率分析以确定关键参数.
- 评估了加快老化对堵塞材料性能和密封力的影响.
主要成果:
- 截止器顶部尺寸 (高度和外径) 被确定为RSF的主要驱动因素.
- RSF显示了与塞的高度和外径的正相关性.
- 堵塞的加快老化导致材料刚度和RSF的轻微增加 (~3%).
结论:
- 有限元模型提供了一个强大的方法来预测RSF在小瓶CCS.
- 堵塞尺寸是确保足够的密封力和CCI的关键设计参数.
- 虽然衰老会增加硬度和RSF,但对所研究条件的力量的影响相对较小.
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