Loss-on-Drying Prediction for a Vibrated Fluidised Bed Dryer by Means of Mass and Energy Balances

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2023-12-08 DOI:10.1007/s12247-023-09802-w
Katharina Kiricenko, Felix Hartmann, Andreas Altmeyer, Peter Kleinebudde
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Abstract

Purpose

Continuous wet granulation and drying require an adequate process control strategy to ensure the product quality. The most important critical quality attributes of dried granules are the granule size distribution and moisture content. Process analytical technologies (PATs) are available for real-time monitoring of moisture content by, e.g., near-infrared spectroscopy (NIRS), which requires additional installation and complex multivariate validation. Thus, a mass and energy balance (MEB) was derived for a vibrated fluidised bed dryer, which is part of the QbCon® 1 intended for continuous wet granulation and drying.

Method

Process parameters that are frequently logged were used for the derivation of a MEB. The predicted MEB was compared with the measured loss-on-drying (LOD) for two different formulations.

Results

The model-derived data were in good agreement with the observed LOD, leading to RMSE values of 0.12–0.45.

Conclusion

The implemented MEB can predict the LOD over time and thus might be suitable as a soft sensor without the installation of additional sensors. The obtained energy flux gives insight into the heat transfer, and the derived energy balance might be used to determine the required energy under certain drying conditions.

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通过质量和能量平衡预测振动流化床干燥器的干燥损耗
目的连续湿法造粒和干燥需要适当的过程控制策略,以确保产品质量。干燥颗粒最重要的关键质量属性是颗粒大小分布和水分含量。工艺分析技术(PAT)可通过近红外光谱(NIRS)等方法实时监测水分含量,但这需要额外的安装和复杂的多变量验证。因此,我们对振动流化床干燥器进行了质量和能量平衡(MEB)推导,该干燥器是 QbCon® 1 系统的一部分,用于连续湿法造粒和干燥。结果模型得出的数据与观测到的 LOD 非常吻合,RMSE 值为 0.12-0.45。结论实施的 MEB 可以预测 LOD 随时间变化的情况,因此可以用作软传感器,而无需安装额外的传感器。所获得的能量通量有助于深入了解热传导情况,得出的能量平衡可用来确定特定干燥条件下所需的能量。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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