How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview of the considerations necessary in the design of continuous pharmaceutical manufacturing processes. This book covers both the theory of continuous processing and the theory for the design of the associated continuous unit operations, along with their characterization and control. It also discusses key practical insights and strategies that the editor and chapter authors have learned while designing powder-to-tablet continuous manufacturing lines. This book includes chapters dedicated to the design and incorporation of Process Analytical Technology (PAT) tools, the application of PAT data to enable distributed process control, and design and implementation of control architecture. With numerous case studies throughout, this is a valuable hands-on guide for all those engaged in or learning about continuous processing in pharmaceutical manufacturing. Provides discussions on the development of strategy blueprints for design of continuous processesShows how to create process flowsheet models from individual unit operation models while emphasizing how the use of these tools facilitates process designIncludes a chapter on characterization methods for materials, use of statistical methods to analyze material property data, and the use of material databases in order to illustrate the importance of material properties in making decisions related to the design of continuous manufacturing processesCovers the evolving regulatory expectations for continuous manufacturing and provides readers with ways to more effectively navigate these expectations INDICE: 1. Introduction - Current State of the Technology 2. Conceptual Design 3. Material Characterization 4. Loss-in-weight feeding 5. Continuous powder mixing 6. Roller compaction 7. Wet granulation 8. Continuous Drying 9. Continuous tableting and coating 10. Role of Process Analytical Technology in Continuous Manufacturing 11. Process modeling 12. Integrated process control 13. Real Time Release and Testing 14. Risk Analysis, Sensitivity, and Optimization 15. Regulatory Expectations 16. The future of continuous processing

• ISBN: 978-0-12-813479-5
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 304
• Fecha Publicación: 01/08/2018
• Nº Volúmenes: 1
• Idioma: Inglés