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首页> 外文期刊>International Journal of Refrigeration >In-line control of the lyophilization process. A gentle PAT approach using software sensors
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In-line control of the lyophilization process. A gentle PAT approach using software sensors

机译：冻干过程的在线控制。使用软件传感器的轻柔PAT方法

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摘要

A lyophilization process is usually only specified in terms of a 'recipe' (shelf temperature and chamber pressure vs. time); according to the recent PAT guidelines issued by FDA, there is the need to develop in-line tools to enable better monitoring and control freeze-drying. In this work an advanced Manometric Temperature Measurement approach, called DPE (Dynamic Parameters Estimation) is first presented, based on a detailed mathematical model. In alternative, the "smart vial" concept is proposed, a Kalman filter based observer allowing an almost continuous monitoring without probes physically inserted into the product. Results obtained for pharmaceutical products in vial in a small industrial prototype equipped with the DPE-based LyoDriuer control software, are presented. The software is capable to determine the optimal shelf temperature for primary drying, ensuring the fastest drying time without overcoming the maximum allowable product temperature both in scouting and production cycles. Finally, the two complementary monitoring systems, the DPE and the "smart uial", are combined in an even more robust hybrid control system.
机译：冻干过程通常仅根据“配方”（机架温度和箱内压力与时间的关系）来指定;根据FDA最近发布的PAT准则，有必要开发在线工具以更好地监视和控制冷冻干燥。在这项工作中，首先基于详细的数学模型，提出了一种称为DPE（动态参数估算）的高级测压温度测量方法。在替代方案中，提出了“智能小瓶”概念，它是一种基于卡尔曼过滤器的观察器，几乎可以连续进行监测，而无需将探针实际插入产品中。展示了在装有DPE的LyoDriuer控制软件的小型工业原型中，样品瓶中药品的结果。该软件能够确定初次干燥的最佳货架温度，从而确保最快的干燥时间，而不会在侦察和生产周期中都超过最高允许产品温度。最终，两个互补的监视系统DPE和“智能仪表盘”组合成一个更加强大的混合控制系统。

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