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ON-OFF Feedback Control of Plug-Flow Crystallization: A Case of Quality-by-Control in Continuous Manufacturing
09 Jun 2023 | Contributor(s):: Koswara, Andy, Nagy, Zoltan K.
Plug-flow crystallization (PFC) is a promising candidate to realizing the paradigm shift from batch-to-continuous pharmaceutical manufacturing. While PFC has been recently touted as the ideal continuous crystallizer due to its compact design, proper mixing, and flexible cooling and antisolvent...
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A Validated Model for Design and Evaluation of Control Architectures for a Continuous Tablet Compaction Process
09 Jun 2023 | Contributor(s):: Nunes de Barros, Fernando, Bhaskar, Aparajith, Singh, Ravendra
The systematic design of an advanced and efficient control strategy for controlling critical quality attributes of the tablet compaction operation is necessary to increase the robustness of a continuous pharmaceutical manufacturing process and for real time release. A process model plays a very...
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A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing
09 Jun 2023 | Contributor(s):: Su, Qinglin, Ganesh, Sudarshan Moreno, Mariana Bommireddy, Yasasvi, Gonzalez, Marcial, Reklaitis, Gintaras V., Nagy, Zoltan K.
The Quality-by-Design (QbD) guidance issued by the US Food and Drug Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing practices including the adoption of continuous manufacturing. Active process control was highlighted recently as a means to improve the QbD...