A Training on: Continuous Manufacturing (Direct Compaction) of Solid Dose Pharmaceutical Products |
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Authors: | Sara Moghtadernejad M Sebastian Escotet-Espinoza Sarang Oka Ravendra Singh Zhanjie Liu Andrés D Román-Ospino Tianyi Li Sonia Razavi Savitha Panikar James Scicolone Gerardo Callegari Douglas Hausner Fernando Muzzio |
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Affiliation: | 1.Department of Chemical and Biochemical Engineering,Rutgers the State University of NJ,Piscataway,USA |
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Abstract: | As the pharmaceutical industry increasingly adopts continuous manufacturing technology, significant attention must be paid to process analytical technology (PAT), process integration, and process control. Published information is no substitute for hands-on comprehensive training, which is critical to implementing and operating continuous pharmaceutical manufacturing systems effectively and efficiently. In this article, an intensive hands-on training course has been developed and implemented at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) based on 15 years of experience and several implemented systems. Here, we brought the details of the four integral components in a continuous direct compression manufacturing process: (1) unit operations, (2) PAT, (3) modeling and process controls, and (4) material characterization. Each section built-in classroom lectures with a brief overview on the theoretical aspects of each topic, followed by a hands-on session covering the classroom theory. The training program is described here in sufficient detail to enable creation of similar programs at other institutions. |
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