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

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.

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Article information: 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 20219, 1502.

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