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Process Simulation and Control for Continuous Pharmaceutical Manufacturing of Solid Drug Products
09 Jun 2023 | Contributor(s):: Ierapetritou, Marianthi, Escotet-Espinoza, M Sebastian, Singh, Ravendra
This chapter focuses on the application and development of unit operation and process models of the major routes of continuous solid dose manufacturing. Process models developed in the chapter are very important tools for the design of control system. The chapter also focuses on the current...
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Model Based Estimation of 2D Crystallization Kinetics From Concentration and CLD Measurements
09 Jun 2023 | Contributor(s):: Szilagyi, Botond, Borsos, Akos Simone, Elena Nagy, Zoltan K., Espuña, Antonio, Graells, Moisès, Puigjaner, Luis
Due to the fact that crystal size and shape influence relevant macroscopic properties of solid particles, the understanding and control of these quantities have increasing importance in particulate science. Crystallization, the primary crystal formation and purification process, is usually...
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Manufacturing of Solid Drug
09 Jun 2023 | Contributor(s):: Ierapetritou, Marianthi, Escotet-Espinoza, M Sebastian, Singh, Ravendra
This chapter focuses on the application and development of unit operation and process models of the major routes of continuous solid dose manufacturing. Process models developed in the chapter are very important tools for the design of control system. The chapter also focuses on the current...
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Design of an Integrated Continuous Manufacturing System
09 Jun 2023 | Contributor(s):: Oka, Sarang S, Escotet-Espinoza, M Sebastian Singh, Ravendra Scicolone, James V Hausner, Douglas B Ierapetritou, Marianthi, Muzzio, Fernando J
This chapter presents a systematic, 12-step approach for designing, implementing, integrating, optimizing, and validating a continuous manufacturing system. Wherever appropriate, it also discusses the regulatory relevance of the technology integration effort. When considering the development of a...
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Challenges and Opportunities in Pharmaceutical Manufacturing Modeling and Optimization
09 Jun 2023 | Contributor(s):: Rogers, Amanda, Ierapetritou, Marianthi Eden, Mario R. Siirola, John D., Towler, Gavin P.
The pharmaceutical industry currently faces economic and regulatory challenges associated with process development. Process systems engineering (PSE) tools can play a role in developing robust and economically efficient manufacturing processes. However pharmaceutical companies have lagged behind...
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Advanced Control of Continuous Pharmaceutical Tablet Manufacturing Processes
09 Jun 2023 | Contributor(s):: Singh, Ravendra, Velazquez, Carlos Sahay, Abhishek Karry, Krizia M Muzzio, Fernando J Ierapetritou, Marianthi G, Ramachandran, Rohit
A novel manufacturing strategy based on continuous processing, integrated with online/inline monitoring tools, coupled with an advanced automatic feedback control system is highly desired for efficient Quality by Design (QbD)-based manufacturing of the next generation of pharmaceutical products...
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A Digital Twin for Process Optimisation in Pharmaceutical Manufacturing
09 Jun 2023 | Contributor(s):: Gerogiorgis, Dimitrios I., Castro-Rodriguez, Daniel
Organic synthesis is a critical step in producing any Active Pharmaceutical Ingredient (API): it encompasses a series of organic (mostly catalytic) reactions and separations, whose purpose is to arrive at a solution of a target molecule, which must then undergo crystallisation for purification,...