(383e) Facilitating Continuous Production in the Pharma Industry with Real-Time Process Management and Ontological Informatics

Continuous manufacturing is well-established in the chemical and process industries. A vital component of a process plant that enables continuous production is a control system that can maintain setpoints, correct faults, and optimize production quality and costs. As the pharmaceutical industries move from batch operation to continuous operations, a real-time control system becomes vital. In addition to the control issues seen commonly in chemical plants, pharmaceutical industries also have to deal with powder flow (necessitating new and more sophisticated control strategies) and with stricter FDA statutory compliance (necessitating a better management system of process knowledge).

In this work, we share some success stories at the Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS), focusing on an ontological informatics system (TOPS: The Ontologies for Particulate Systems) and a real-time process management (RTPM) system, both developed in-house at Purdue University. The RTPM system comprises three main layers: one that maintains setpoints in the presence of random disturbances, one that decides what setpoints should be used across the process, and one which detects, diagnoses and corrects faults or exceptional events. In addition, the process knowledge (process models, control models, equipment parameters, material properties, process flowsheets, and process settings) is stored in TOPS, and used everywhere else. We describe our progress in all three control layers of the RTPM and how they work together along with TOPS to critically facilitate continuous production, process validation, and consistency of knowledge across the entire production operations. We show our results for tablet manufacture, describe our work in progress for film/gel production, and offer some general conclusions for both the pharmaceutical as well as the control communities.