How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems - 1st Edition - ISBN: 9780128134795

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

1st Edition

Editors: Fernando Muzzio Sarang Oka
Paperback ISBN: 9780128134795
Imprint: Academic Press
Published Date: 1st August 2018
Page Count: 304
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Description

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.

Key Features

  • Provides discussions on the development of strategy blueprints for design of continuous processes
  • Shows how to create process flowsheet models from individual unit operation models while emphasizing how the use of these tools facilitates process design
  • Includes 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 processes
  • Covers the evolving regulatory expectations for continuous manufacturing and provides readers with ways to more effectively navigate these expectations

Readership

Pharmaceutical industry professionals engaged or planning to engage in the continuous manufacturing process; graduate students in the pharmaceutical sciences or chemical engineering who are pursuing advanced courses in pharmaceutical process design

Table of Contents

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

Details

No. of pages:
304
Language:
English
Copyright:
© Academic Press 2018
Published:
Imprint:
Academic Press
Paperback ISBN:
9780128134795

About the Editor

Fernando Muzzio

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.

Affiliations and Expertise

Distinguished Professor, Pharmaceutical Engineering Training Program, Department of Chemical and Biochemical Engineering, Director, NSF ERC on Structured Organic Particulate Systems PhD, Distinguished Professor, Pharmaceutical Engineering Training Program, Department of Chemical and Biochemical Engineering and Director, NSF ERC on Structured Organic Particulate Systems, Rutgers University, Piscataway, NJ, USA

Sarang Oka

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