A Training on: Continuous Manufacturing (Direct Compaction) of Solid Dose Pharmaceutical Products

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.