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Model-Guided Development of a Semi-Continuous Drying Process

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Abstract

Introduction

With an increased adoption of continuous manufacturing for pharmaceutical production, the ConsiGma® CTL25 wet granulation and tableting line has reached widespread use. In addition to the continuous granulation step, the semi-continuous six-segmented fluid bed dryer is a key unit in the line. The dryer is expected to have an even distribution of the inlet air between the six drying cells. However, process observations during manufacturing runs showed a repeatable pattern in drying time, which suggests a variability in the drying performance between the different cells of the dryer. The aim of this work is to understand the root-cause of this variability.

Materials and methods

In a first step, the variability in the air temperature and air flow velocity between the dryer cells was measured on an empty dryer. In a second step, the experimental data were interpreted with the help of results from computational fluid dynamics (CFD) simulations to better understand the reasons for the observed variability.

Results

The CFD simulations were used to identify one cause of the measured difference in the air temperature, showing the impact of the air inlet design on the temperature distribution in the dryer.

Conclusions

Although the simulation could not predict the exact temperature, the trend was similar to the experimental observations, demonstrating the added value of this type of simulation to guide process development, engineering decisions and troubleshoot equipment performance variability.

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Acknowledgements

Special thanks go to Eyke Slama for the design and manufacturing of the probe holder and to Patrick Vorraber for testing it prior to our experimental work.

Funding

The Research Center Pharmaceutical Engineering (RCPE) is funded within the framework of COMET—Competence Centers for Excellent Technologies by BMK, BMDW, Land Steiermark, and SFG. The COMET program is managed by the FFG.

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Authors and Affiliations

  1. UCB Pharma S.A, Allée de La Recherche, 60 1070, Brussels, Belgium

    Anthony Grelier, Franco Colacino, Gabrielle Pilcer & Fanny Stauffer

  2. RCPE GmbH, Inffeldgasse 13/2, 8010, Graz, Austria

    Matej Zadravec, Johan Remmelgas, Thomas Forgber & Theresa Hörmann-Kincses

Authors
  1. Anthony Grelier
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  2. Matej Zadravec
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  3. Johan Remmelgas
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  8. Theresa Hörmann-Kincses
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Correspondence to Fanny Stauffer or Theresa Hörmann-Kincses.

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Grelier, A., Zadravec, M., Remmelgas, J. et al. Model-Guided Development of a Semi-Continuous Drying Process. Pharm Res 39, 2005–2016 (2022). https://doi.org/10.1007/s11095-022-03361-4

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  • DOI: https://doi.org/10.1007/s11095-022-03361-4

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