在架式系统中嵌入的瓶子中的药品的冷干燥-第二部分:初级干燥行为
Fiora Artusio1, Marco Adami2, Antonello A Barresi1
1Department of Applied Science and Technology, Politecnico di Torino, 24 Corso Duca degli Abruzzi, 10129 Torino, Italy.
Pharmaceutics
|November 25, 2023
概括
生物制药的冷干燥包括优化瓶装量,以实现高效的初级干燥. 机架系统可以提高传热均性,减少冷干燥过程中的变异性,这对于治疗稳定性至关重要.
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.
- 生物技术是生物技术.
背景情况:
- 冷干燥 (溶解) 对于生物制药的稳定性和分布至关重要.
- 初级干燥是能源密集型的,并决定了整体过程时间.
- 瓶子装载配置显著影响冷和干燥阶段.
研究的目的:
- 为了在两个装载配置中比较初级干燥过程中瓶子的热行为:直接的货架接触与架子系统.
- 为了评估室内压力,架子温度和瓶子位置对传热效率的影响.
- 评估负载配置对瓶间温度均性的影响.
主要方法:
- 在冷干燥中研究的总热传递系数 (U).
- 直接接触与嵌套的瓶子配置在一个机架系统中进行比较.
- 室内压力 (5-30Pa) 和货架温度 (-10°C至+30°C) 不同.
- 分析了不同瓶子位置 (中心,半边界,边界) 的热行为.
- 利用热成像进行温度差异分析.
主要成果:
- 嵌套小瓶的传热系数因其悬浮配置而对压力依赖性较小.
- 这两种配置均显示出相似的热传递效率,低于10 Pa.
- 在更高的压力 (>10Pa) 下,直接接触瓶具有比嵌套瓶更高的传热系数.
- 支架系统显著降低了瓶间的变化,提高了中央瓶的均性.
- 热成像证实了瓶子和支架系统之间的温度差异很小.
结论:
- 机架系统在初级干燥过程中提供了更好的热均性,对于一致的生物制药冷干燥至关重要.
- 负载配置的选择会影响传热效率,特别是在更高的室内压力下.
- 机架系统减轻了与压力相关的热传递变化,从而导致更可预测的冷化结果.
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