Chapter Book (1-6 of 6)

1. Real-time feasible model-based crystal size and shape control of crystallization processes

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   09 Jun 2023 | Contributor(s):: Szilagyi, Botond, Nagy, Zoltan K.

   The simultaneous control of crystal size and shape is particularly important in fine chemical and pharmaceutical crystallization. These two quantities influence the dissolution rate and bioavailability of final drug products, and also contribute to the manufacturability and efficiency of...

2. Model Based Estimation of 2D Crystallization Kinetics From Concentration and CLD Measurements

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   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...

3. Manufacturing of Solid Drug

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   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...

4. Design of an Integrated Continuous Manufacturing System

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   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...

5. Control of Batch and Continuous Crystallization Processes using Reinforcement Learning

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   09 Jun 2023 | Contributor(s):: Benyahia, Brahim, Anandan, Paul Danny Rielly, Chris Türkay, Metin, Gani, Rafiqul

   In crystallization processes, the control of particle size distribution, shape and purity are crucial to achieve the targeted critical quality attributes of the final drug product and meet the pharmaceutical regulatory requirements. This work presents novel optimal trajectory tracking control...

6. Challenges and Opportunities in Pharmaceutical Manufacturing Modeling and Optimization

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   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...