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Implementation of Dynamic and Static Moisture Control in Fluidized Bed Granulation
Liang Zhong1, Lele Gao1, Lian Li1
1NMPA Key Laboratory for Technology Research and Evaluation of Drug Products, School of Pharmaceutical Sciences, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.
Abstract:
The application of process analysis and control is essential to enhance process understanding and ensure output material quality. The present study focuses on the stability of the feedback control system for a fluidized bed granulation process. Two strategies of dynamic moisture control (DMC) and static moisture control (SMC) were established based on the in-line moisture value obtained from the near-infrared sensor and control algorithm. The performance of these strategies on quality consistency control was examined using process moisture similarity analysis and principal component analysis. The stable moisture control performance and low batch-to-batch variability indicated that the DMC method was significantly better than other granulation methods. In addition, the investigation of robustness further showed that the implemented DMC method was able to produce predetermined target moisture values by varying process parameters. This study provides an advanced and simple control method for fluidized bed granulation quality assurance.
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