Chapter 13 - Model-based control system design and evaluation for continuous tablet manufacturing processes (via direct compaction, via roller compaction, via wet granulation)

Abstract

Abstract The real-time control of pharmaceutical manufacturing process is required to achieve the desired predefined Critical Quality Attributes (CQAs), satisfy precisely the tight regulatory constraints and high product quality expectations and thereby to improve product efficacy and patient safety. The control system also optimizes the resources involved in manufacturing, reduces the offline lab-based testing, and facilitates the real-time release (RTR) of the pharmaceutical products. The continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end-product quality as desired by QbD (quality by design)-based efficient manufacturing. The process model is an important “virtual experimentation tool” that can be effectively used to design and evaluate a control system for continuous pharmaceutical manufacturing. In this book chapter, the model-based design of control system for continuous pharmaceutical tablet manufacturing process has been described. The control system has been designed for three continuous pharmaceutical manufacturing routes, namely, via direct compaction, via roller compaction, and via wet granulation. The performance of different control strategies and algorithms has been evaluated to identify the best control options for continuous pharmaceutical manufacturing process. The precise control of the quality of the pharmaceutical product requires corrective actions on the process/raw material variability before they can influence the product quality. Therefore, a combined feedforward/feedback control system is more effective.