Real-time feedback control of twin-screw wet granulation based on image analysis

Lajos Madarász, Zsombor Kristóf Nagy, István Hoffer, Barnabás Szabó, István Csontos, Hajnalka Pataki, Balázs Démuth, Bence Szabó, Kristóf Csorba, G. Marosi

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9 Citations (Scopus)

Abstract

The present paper reports the first dynamic image analysis-based feedback control of continuous twin-screw wet granulation process. Granulation of the blend of lactose and starch was selected as a model process. The size and size distribution of the obtained particles were successfully monitored by a process camera coupled with an image analysis software developed by the authors. The validation of the developed system showed that the particle size analysis tool can determine the size of the granules with an error of less than 5 µm. The next step was to implement real-time feedback control of the process by controlling the liquid feeding rate of the pump through a PC, based on the real-time determined particle size results. After the establishment of the feedback control, the system could correct different real-life disturbances, creating a Process Analytically Controlled Technology (PACT), which guarantees the real-time monitoring and controlling of the quality of the granules. In the event of changes or bad tendencies in the particle size, the system can automatically compensate the effect of disturbances, ensuring proper product quality. This kind of quality assurance approach is especially important in the case of continuous pharmaceutical technologies.

Original languageEnglish
Pages (from-to)360-367
Number of pages8
JournalInternational Journal of Pharmaceutics
Volume547
Issue number1-2
DOIs
Publication statusPublished - Aug 25 2018

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Keywords

  • Continuous twin-screw wet granulation (TSWG)
  • Dynamic Image Analysis (DIA)
  • Feedback control
  • Process Analytical Technology (PAT)
  • Process Analytically Controlled Technology (PACT)

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Madarász, L., Nagy, Z. K., Hoffer, I., Szabó, B., Csontos, I., Pataki, H., Démuth, B., Szabó, B., Csorba, K., & Marosi, G. (2018). Real-time feedback control of twin-screw wet granulation based on image analysis. International Journal of Pharmaceutics, 547(1-2), 360-367. https://doi.org/10.1016/j.ijpharm.2018.06.003