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
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
Fernando Muzzio is a Distinguished Professor at Rutgers University. For the last 22 years, pharmaceutical product and process design has been Professor Muzzio's main research and educational focus. His research interests comprise continuous manufacturing, powder mixing, powder flow, segregation, compression, mixing and flow of liquids and suspensions, capsule filling, tablet dissolution, and tablet coating. Dr. Muzzio has published more than 260 research papers in this area and his h-index is currently 45. He is a frequent advisor and lecturer at FDA events, and in 2010 he was appointed a voting member of the FDA committee on Pharmaceutical Sciences and Clinical Pharmacology.
Professor Fernando Muzzio is also the director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems. The center, which has a total budget in excess of $8 million per year, focuses on pharmaceutical product and process design, with special emphasis on continuous manufacturing, particle engineering, and personalized medicine. The FDA and 45 companies, including Amgen, Vertex, Lilly, Pfizer, Merck, Bristol-Myers Squibb and more, are currently members of the center.
Oka, Sarang
Dr. Sarang Oka is a process development engineer in continuous manufacturing at Hovione. He is responsible for drafting Hovione's process development strategy for their continuous drug product portfolio. He liases with Hovione's customers to enable efficient tech transfer of their products to Hovione's continuous manufacturing rig.
Dr. Oka received his PhD in Chemical Engineering from Rutgers Univesity under the guidance of Dr. Fernando Muzzio. His thesis focused on continuous powder mixing and granulation, and examined the role of continuous manufacturing to enable direct compression, of otherwise directly incompressible formulations. He was also part of the team at Rutgers University that helped develop Prezista, the first FDA approval for a batch-to-cotinuous conversion of a drug product. Dr. Oka holds a BS in chemical engineering from the University of Mumbai.
