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Updated: Feb 3, 2026
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改变冷凍產品的容器封閉系統:對加工效率和產品品質的真實或感知風險?
Maxwell Korang-Yeboah1, Ann-Marie Afrifa2, Lisa Ma3
1Division of Product Quality Research V, Office of Product Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
Journal of pharmaceutical sciences
|February 1, 2026
概括
改变玻璃瓶制造商的冷化可以影响工艺效率和产品质量,由于热传递的变化. 优化瓶子选择和工艺参数对于强大的冷干燥至关重要.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
背景情况:
- 容器封闭系统 (CCS),特别是玻璃瓶,对于冷化过程中的热传递至关重要.
- 在CCS的变化可以显著改变冷化过程的性能和产品质量.
研究的目的:
- 系统地评估与在不调整冷化工艺的情况下改变瓶子制造商相关的风险.
- 识别影响过程失败的关键CCS变量,配方特性和过程参数.
主要方法:
- 在不同压力下比较不同制造商的瓶子的质量流速和瓶子传热系数.
- 评估瓶子位置和配方固体含量对工艺风险的影响.
- 为了降低风险,研究了化和控制的冰核化.
- 利用微型CT成像和AI/ML进行机械理解.
主要成果:
- 瓶子的几何形状,特别是底部的曲率,会影响热传递,特别是在更高的压力和中心瓶子位置时.
- 制造商A的瓶子显示的传热系数比制造商B高25%,减少了干燥时间.
- 较低固体配方对瓶子制造商的变化更为敏感,表现出更大的微观结构变化.
- 和受控核化最小化了性能变化.
结论:
- 切换瓶子制造商对冷化工艺效率和产品质量构成重大风险.
- 风险受工艺参数,瓶子位置和药物产品特征的影响.
- 瓶热传递系数 (Kv) 是工艺风险的指标,但不捕捉微观结构变化.
- 将CCS属性集成到工艺开发中,对于强大的冷化至关重要.
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