How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems
Language: English
Published by Elsevier Science Publishing Co Inc, 2019
- Softcover
- New
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- Title
- How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems
- Author
- Fernando Muzzio
- Publisher
- Elsevier Science Publishing Co Inc
- Publication year
- 2019
- Condition
- New
- Binding
- Paperback / softback
- Language
- English
- ISBN 10
- 0128134798
- ISBN 13
- 9780128134795
- Item weight
- 730 grams
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
"Synopsis" may belong to another edition of this title.
About the Author
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.
Dr. Sarang Oka is a Senior Manager at Hovione where he heads the continuous drug product manufacturing area at Hovione's site in East Windsor, New Jersey, overseeing all technical functions including manufacturing, process development, and process analytical technology (PAT).
Dr. Oka received his PhD in Chemical Engineering from Rutgers University. His thesis focused on continuous powder mixing and granulation, and examined the role of continuous manufacturing in enabling direct compression of otherwise directly incompressible formulations. He was also part of the team at Rutgers University and NSF ERC-SOPS that helped develop Prezista, the first FDA approval for a batch-to-continuous conversion of a drug product. Dr. Oka holds a BS in chemical engineering from Mumbai University.
"About the title" may belong to another edition of this title.
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