Validating a Numerical Simulation of the ConsiGma(R) Coater
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Research Article Theme: Modeling and Simulations of Drug Product Manufacturing Unit Operations Guest Editors: Alexander Russell and Maxx Capece
Validating a Numerical Simulation of the ConsiGma(R) Coater Peter Boehling,1,5 Dalibor Jacevic,1 Frederik Detobel,2 James Holman,2 Laura Wareham,3 Matthew Metzger,3 and Johannes G. Khinast1,4
Received 1 July 2020; accepted 7 October 2020 Abstract.
Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating the switch from traditional batch production to the continuous mode of operation. The latter offers certain advantages over batch production, e.g., operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process.
KEY WORDS: CFD-DEM; tablet coating; solid processes; heat and mass transfer.
INTRODUCTION Continuous manufacturing (CM) is increasingly applied in the pharmaceutical industry (1,2). In comparison to batch production, it enables a higher throughput while simultaneously decreasing the waste and energy consumption and production costs (3). Since the inline measurements are typically intrinsic to the process design, CM allows enhanced process control (4). Above all, CM requires a high level of process understanding (5,6). In light of the transition from batch to continuous manufacturing, GEA developed the ConsiGma® continuous Guest Editors: Alexander Russell and Maxx Capece 1
Research Center Pharmaceutical Engineering GmbH, Graz, Austria. 2 GEA Process Engineering NV, Wommelgem, Belgium. 3 Merck & Co., Inc., Kenilworth, New Jersey, USA. 4 IPPT, Graz University of Technology, Graz, Austria. 5 To whom correspondence should be addressed. (e–mail: peter.boehling@r
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