Integrated Systems Science and Control Platform for Direct Compaction Tablet Manufacturing
Using Process Analytical Technology (PAT) tools developed at the Center for Structured Organic Particulate Systems (C-SOPS), an NSF-funded Engineering Research Center (ERC) based at Rutgers University (RU) in partnership with New Jersey Institute of Technology (NJIT), Purdue University (PU), and the University of Puerto Rico-Mayaguez (UPRM), an integrated, continuous, direct compaction tablet manufacturing process has been demonstrated. The process includes a control platform for centralized automatic operation of feeders, a blender, mill, and tablet press.
C-SOPS is leveraging new sensing methodologies to enable novel production routes in the pharmaceutical industry. The use of advanced control strategies in CSOPS’ direct compaction tablet manufacturing process reveals the importance of closed loop production as well as the integration of data management capabilities in automated pharmaceutical processing.
In the last five years, CSOPS’ accomplishments in the areas of sensing, process integration, modeling, and optimization have proven to be of tremendous importance, with great attention received from industrial mentors and the scientific community. The process analytical technology tools provide a novel framework for innovative pharmaceutical development, manufacturing, and quality assurance.
In the integrated continuous direct compaction tablet manufacturing process developed at C-SOPS, the control hardware, software, and sensors have been integrated in a direct compaction and wet granulation line at RU, roller compaction line at PU and tumble mixer line at UPRM. Sensing using near-infrared (NIR) and visible (Raman) spectroscopy has made possible the online measurement of critical process parameters.
An integrated process flowsheet model was evolved with the control platform for onsite design and evaluation of the control system. The direct compaction tablet manufacturing process recently demonstrated at CSOPS establishes for the first time the value of flowsheet modeling in: (a) identifying critical process parameters; (b) designing the most efficient control strategy for the individual units and for the entire process; (c) determining the range of conditions where the process remains valid (design space); and (d) identifying the optimal operating parameters for the process to produce at the maximum efficiency.
