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一种基于蒙特卡洛模拟的方法来定义目标填充体积和栓塞插入深度,用于制造预填注射器组合产品
Robert Kuo1, Kavin Kowsari1, Kaitlin Wang1
1Pharmaceutical Sciences and Clinical Supply, MRL, Merck & Co., Inc., Rahway, NJ 07065, USA.
Journal of pharmaceutical sciences
|October 12, 2025
概括
蒙特卡洛模拟通过预测填充量和堵塞深度变化,优化了预填充注射器 (PFS) 制造. 这种方法降低了商业生产的风险,确保了产品的质量和无菌性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工艺工程是过程工程.
- 药物输送系统 药物输送系统
背景情况:
- 优化填充体积和塞孔插入深度对于预填注射器 (PFS) 组合产品至关重要.
- 传统的开发运行对于参数验证来说是昂贵和耗时的.
- 确保一致的可交付量和无菌性对于产品质量至关重要.
研究的目的:
- 开发一个预测模型,用于填充量和塞插入深度在PFS制造中的变化.
- 为了建立最佳的过程参数目标和容忍范围.
- 为了降低商业规模生产的风险,并确保符合批量接受标准.
主要方法:
- 利用蒙特卡洛模拟来模拟输入参数的变化.
- 开发了可交付量和空气间隙大小的管理方程.
- 包含的输入变量,如无菌屏障高度,摩擦力和部件尺寸.
主要成果:
- 模拟预测了基于输入参数统计分布的结果变化.
- 确定填充体积和塞栓插入深度的目标值和容忍范围.
- 制造PFS批量达到质量和无菌标准的概率最大化.
结论:
- 蒙特卡洛模拟为优化PFS制造参数提供了一种有效,经济高效的方法.
- 预测建模可以在大规模生产之前进行可靠的流程定义.
- 这种方法通过确保产品的一致性和质量,提高了成功商业化的可能性.
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