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 on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.

With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.

• Discusses the development of strategy blueprints in the design of continuous processes
• Shows how to create process flowsheet models from individual unit operation models
• Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases
• Covers the evolving regulatory expectations for continuous manufacturing
• Provides readers with ways to more effectively navigate these expectations

Contenu

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