Implementation of control system into continuous pharmaceutical manufacturing pilot plant (powder to tablet)

Abstract Real-time process control is highly desired for efficient quality by design (QbD)-based pharmaceutical manufacturing. A control system ensures the predefined end-product quality, satisfies the high regulatory constraints, facilitates real-time release of the product, and optimizes the resources. In this book chapter, the implementation of the control system into continuous pharmaceutical tablet manufacturing process has been reviewed. A systematic framework for the control system implementation has been described. The framework has been applied to implement the control system into direct compaction continuous pharmaceutical tablet manufacturing pilot plant situated at Rutgers University. The implementation of the control system through spectroscopic as well as nonspectroscopic sensors has been reviewed. Integration of control hardware and software is different in case of both types of sensors, and therefore both cases require a slightly different approach for control system implementation. In spectroscopic cause, an NIR (Near-Infrared) sensor, an online prediction tool, a PAT (Process Analytical Technology) data management tool, and a control platform are needed to close the control loop, while in nonspectroscopic case, only a sensor and a control platform are needed. Advanced model predictive control (MPC) system as well as classical PID controller have been implemented. The closed-loop process performance has been practically demonstrated through experiments.

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