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Article

Analysis of the Effects of Process Parameters on Start-Up Operation in Continuous Wet Granulation

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Department of Chemical System Engineering, The University of Tokyo, Tokyo 113-8656, Japan
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Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, B-9000 Ghent, Belgium
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BIOMATH, Department of Data Analysis and Mathematical Modelling, Ghent University, B-9000 Ghent, Belgium
*
Author to whom correspondence should be addressed.
Academic Editor: Luis Puigjaner
Processes 2021, 9(9), 1502; https://doi.org/10.3390/pr9091502
Received: 13 July 2021 / Revised: 13 August 2021 / Accepted: 20 August 2021 / Published: 25 August 2021
(This article belongs to the Special Issue Decision-Support Tools for Pharmaceutical Processes)
Toward further implementation of continuous tablet manufacturing, one key issue is the time needed for start-up operation because it could lead to lower product yield and reduced economic performance. The behavior of the start-up operation is not well understood; moreover, the definition of the start-up time is still unclear. This work investigates the effects of process parameters on the start-up operation in continuous wet granulation, which is a critical unit operation in solid drug manufacturing. The profiles of torque and granule size distribution were monitored and measured for the first hour of operation, including the start-up phase. We analyzed the impact of process parameters based on design of experiments and performed an economic assessment to see the effects of the start-up operation. The torque profiles indicated that liquid-to-solid ratio and screw speed would affect the start-up operation, whereas different start-up behavior resulted in different granule size. Depending on the indicator used to define the start-up operation, the economic optimal point was significantly different. The results of this study stress that the start-up time differs according to the process parameters and used definition, e.g., indicators and criteria. This aspect should be considered for the further study and regulation of continuous manufacturing. View Full-Text
Keywords: continuous manufacturing; pharmaceutical tablet; design of experiments; torque; granule size distribution; first-order system; kernel PCA; economic assessment; regulations continuous manufacturing; pharmaceutical tablet; design of experiments; torque; granule size distribution; first-order system; kernel PCA; economic assessment; regulations
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MDPI and ACS Style

Matsunami, K.; Ryckaert, A.; Peeters, M.; Badr, S.; Sugiyama, H.; Nopens, I.; De Beer, T. Analysis of the Effects of Process Parameters on Start-Up Operation in Continuous Wet Granulation. Processes 2021, 9, 1502. https://doi.org/10.3390/pr9091502

AMA Style

Matsunami K, Ryckaert A, Peeters M, Badr S, Sugiyama H, Nopens I, De Beer T. Analysis of the Effects of Process Parameters on Start-Up Operation in Continuous Wet Granulation. Processes. 2021; 9(9):1502. https://doi.org/10.3390/pr9091502

Chicago/Turabian Style

Matsunami, Kensaku, Alexander Ryckaert, Michiel Peeters, Sara Badr, Hirokazu Sugiyama, Ingmar Nopens, and Thomas De Beer. 2021. "Analysis of the Effects of Process Parameters on Start-Up Operation in Continuous Wet Granulation" Processes 9, no. 9: 1502. https://doi.org/10.3390/pr9091502

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