4.4 Article

Implementation of Dynamic and Static Moisture Control in Fluidized Bed Granulation

Journal

AAPS PHARMSCITECH
Volume 23, Issue 6, Pages -

Publisher

SPRINGER
DOI: 10.1208/s12249-022-02334-5

Keywords

Fluidized bed granulation; Near-infrared spectroscopy; Quality consistency; Dynamic moisture control; Static moisture control

Funding

  1. National Key Research and Development Program of China [2021YFB3201200, 2021YFB3201202]
  2. Major Science And Technology Innovation Project of Shandong Province [2019JZZY021020]
  3. Qinghai Special Project of Innovation Platform for Basic Conditions of Scientific Research of China [2020-ZJ-T05]
  4. Future Scholar Program of Shandong University
  5. Major Scientific and Technological Innovation Project of Shandong [2018CXGC1405]

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The 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 examined, and DMC method showed significantly better performance on quality consistency control. Furthermore, the implemented DMC method demonstrated robustness by producing predetermined target moisture values.
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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