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首页> 美国卫生研究院文献>Pharmaceutics >Model-Based Optimisation and Control Strategy for the Primary Drying Phase of a Lyophilisation Process
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Model-Based Optimisation and Control Strategy for the Primary Drying Phase of a Lyophilisation Process

机译：冻干过程主要干燥阶段的基于模型的优化和控制策略

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The standard operation of a batch freeze-dryer is protocol driven. All freeze-drying phases (i.e., freezing, primary and secondary drying) are programmed sequentially at fixed time points and within each phase critical process parameters (CPPs) are typically kept constant or linearly interpolated between two setpoints. This way of operating batch freeze-dryers is shown to be time consuming and inefficient. A model-based optimisation and real-time control strategy that includes model output uncertainty could help in accelerating the primary drying phase while controlling the risk of failure of the critical quality attributes (CQAs). In each iteration of the real-time control strategy, a design space is computed to select an optimal set of CPPs. The aim of the control strategy is to avoid product structure loss, which occurs when the sublimation interface temperature ( ) exceeds the the collapse temperature ( ) common during unexpected disturbances, while preventing the choked flow conditions leading to a loss of pressure control. The proposed methodology was experimentally verified when the chamber pressure and shelf fluid system were intentionally subjected to moderate process disturbances. Moreover, the end of the primary drying phase was predicted using both uncertainty analysis and a comparative pressure measurement technique. Both the prediction of and end of primary drying were in agreement with the experimental data. Hence, it was confirmed that the proposed real-time control strategy is capable of mitigating the effect of moderate disturbances during batch freeze-drying.
机译：间歇式冷冻干燥机的标准操作由协议驱动。所有冷冻干燥阶段（即冷冻，初次和二次干燥）均在固定的时间点依次进行编程，并且在每个阶段内，关键过程参数（CPP）通常保持恒定或在两个设定点之间线性插值。这种批量冷冻干燥机的操作方式被证明是耗时且效率低下的。基于模型的优化和实时控制策略，包括模型输出的不确定性，可以帮助加快主要干燥阶段，同时控制关键质量属性（CQA）失败的风险。在实时控制策略的每次迭代中，都会计算设计空间以选择一组最佳的CPP。该控制策略的目的是避免产品结构损失，该损失在升华界面温度（）超出意外干扰期间常见的塌陷温度（）时发生，同时防止阻塞的流量条件导致压力控制损失。当室内压力和架子流体系统故意受到中等程度的过程干扰时，通过实验验证了所提出的方法。此外，使用不确定性分析和比较压力测量技术可以预测一次干燥阶段的结束。一次干燥的预测和结束均与实验数据一致。因此，证实了所提出的实时控制策略能够减轻间歇式冷冻干燥期间中度干扰的影响。

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