A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process

Abstract

A novel manufacturing strategy based on continuous processing integrated with online/inline monitoring tools coupled with an advanced control system 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 work, a systematic framework for the onsite design and implementation of the control system in continuous tablet manufacturing process has been developed. The framework includes a generic methodology and supporting tools through which the control system can be designed at the manufacturing site and can be implemented for closed-loop operation. The control framework has different novel features such as the option to run the plant in closed-loop (MPC/PID), open-loop and simulation mode. NIR sensor, an online prediction tool, a PAT data management tool, and a control platform have been used to close the control loop.