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Ensuring tablet quality via model-based control of a continuous direct compaction process.

Martin Kirchengast1, Selma Celikovic1, Jakob Rehrl2

  • 1Institute of Automation and Control, Graz University of Technology, Graz, Austria.

International Journal of Pharmaceutics
|July 1, 2019
PubMed
Summary
This summary is machine-generated.

Continuous pharmaceutical manufacturing enhances productivity and quality. This study introduces a control strategy for direct compaction, ensuring consistent active pharmaceutical ingredient concentration and tablet press (TP) hopper levels, even during variations.

Keywords:
Continuous manufacturingDirect compactionModel predictive controlProcess control

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Area of Science:

  • Chemical Engineering
  • Pharmaceutical Technology
  • Process Control

Background:

  • Continuous manufacturing offers advantages over batch processing in pharmaceuticals, including improved efficiency and consistent product quality.
  • Direct compaction is a key process in continuous tablet production.

Purpose of the Study:

  • To present a control strategy for direct compaction in a continuous tablet production line.
  • To ensure stable active pharmaceutical ingredient (API) concentration and tablet press (TP) hopper levels.

Main Methods:

  • A data-driven, linear modeling approach was used.
  • A Smith predictor was developed for API concentration control.
  • A model predictive controller was implemented for TP hopper level control.

Main Results:

  • The control strategy effectively managed API concentration variations.
  • The TP hopper level was maintained consistently.
  • A system for discarding out-of-specification material before the TP was implemented.

Conclusions:

  • The developed control strategy is effective for continuous direct compaction.
  • The approach ensures steady product quality and process efficiency.
  • Validation through simulations and pilot plant implementation confirms the strategy's robustness.