Katharina Kiricenko, Felix Hartmann, Andreas Altmeyer, Peter Kleinebudde
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引用次数: 0
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.
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.