The continuous pharmaceutical manufacture (CPM) plant and control architecture developed earlier is currently being widely implemented in industries [1,2]. CPM indeed provides an appropriate platform to implement suitable monitoring and control architecture, to improve product quality, and to minimize product rejection and operating expenses. However, some process system engineering (PSE) issues still need to be addressed more to fully realize the advantages of closed-loop CPM, such as novel sensor development, real time optimization (RTO), real time release (RTR), material traceability, validated CPM model, and standardization of control module. In this work, a systematic framework including the methods and tools for design, development, evaluation, and implementation of advanced process sensing and control architecture has been developed and applied to a continuous pharmaceutical tablet manufacturing pilot-plant. The resulting sensing and control architecture consists of multiple layers including real time monitoring, local and supervisory control architecture, Principle Component Analysis (PCA) based supervisory control and RTO. As needed for closed-loop control, new sensing technique has been developed for real time monitoring of powder level and powder bulk density. The results demonstrate improved critical quality attributes (CQAs) under the proposed sensing and control scenario indicating its wide applicability in pharmaceutical industries.

• Rutgers, The State University of New Jersey

• Oral doses
• Modeling

1. continuous
2. Control
3. manufacturing
4. modeling
5. N/A
6. Oral doses
7. Pharmaceutical
8. Research Article