Process Systems Engineering for Pharmaceutical Manufacturing - 1st Edition - ISBN: 9780444639639

Process Systems Engineering for Pharmaceutical Manufacturing, Volume 41

1st Edition

From Product Design to Enterprise-Wide Decision-Making

Editors: Ravendra Singh Zhihong Yuan
Hardcover ISBN: 9780444639639
Imprint: Elsevier
Published Date: 1st March 2018
Page Count: 612
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Table of Contents

Part 1 Pharmaceutical product and process synthesis and design
1. Novel product discovery and development for pharmaceutical industry
2. Measurement and property prediction of pharmaceutical compounds
3. Modeling and prediction of the crystal structure of pharmaceutical molecules
4. Crystal shape engineering for pharmaceutical manufacturing
5. Phase Diagrams based pharmaceutical product formulation
6. Systematic design and synthesis of pharmaceutical manufacturing
7. Plant-wide design and economic evaluation of continuous pharmaceutical production processes

Part 2 Pharmaceutical production process modelling, simulation, analysis and optimization
8. Modeling, simulation and analysis of the continuous wet granulation (WG) system
9. Comparative studies on the modelling, simulation and analysis of continuous pharmaceutical manufacturing via roller compaction and direct compaction
10. Plant-wide dynamic model for the continuous pharmaceutical process
11. Reduced-order model development for complex pharmaceutical manufacturing
12. Data-driven model development for pharmaceutical manufacturing
13. Global sensitivity, feasibility and flexibility analysis of pharmaceutical manufacturing processes
14. Flowsheet optimization for continuous pharmaceutical manufacturing processes

Part 3 Pharmaceutical production process dynamics, control, monitoring and operations
15. Process dynamics and control of API manufacturing and purification processes
16. Model-based control system design and evaluation for continuous tablet manufacturing processes (via direct compaction, via roller compaction, via wet granulation)
17. Advanced hybrid model predictive control of continuous pharmaceutical manufacturing process
18. Advanced control for the continuous dropwise additive manufacturing of pharmaceutical products
19. Control system implementation and plant-wide control of continuous pharmaceutical manufacturing pilot plant
20. Intelligent exceptional event management for continuous pharmaceutical tablet manufacturing process
21. Process monitoring and management system for pharmaceutical crystallization processes

Part 4 Enterprise-wide optimization for Pharmaceutical Production
22. Enterprise-wide optimization for pharmaceutical manufacturing
23. Pharmaceutical enterprise: R&D Pipeline planning
24. Modeling, algorithms and solution for the production planning of pharmaceutical manufacturing
25. Capacity planning in pharmaceutical manufacturing
26. Supply chain design and management for pharmaceutical manufacturing
27. Optimal scheduling for the pharmaceutical manufacturing site
28. Optimal production management for biopharmaceutical manufacturing

Part 5 Future directions in the application of process systems engineering to pharmaceutical manufacturing
29. Perspectives for the application of PSE to pharmaceutical manufacturing-views from industry
30. Perspective on PSE in pharmaceutical process development and innovation-views from academia


Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes.

Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering.

Key Features

  • Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes
  • Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products
  • Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing


Reference for graduates, post graduates and researchers in academia and (pharma) industry. Chemists/ Chemical engineers in pharmaceutical companies. It could be used for novel courses on pharmaceutical systems engineering and by regulators (eg FDA) to familiarize themselves with the current PSE methods and tools


No. of pages:
© Elsevier 2018
Hardcover ISBN:

About the Editors

Ravendra Singh Editor

Dr. Ravendra Singh is Assistant Research Professor at C-SOPS, Department of Chemical and Biochemical Engineering, Rutgers University, USA, working in Pharmaceutical System Engineering research field. C-SOPS is a unique pharmaceutical center founded by National Science Foundation (NSF) USA with annual budget exceeding 40 million USD. Dr. Singh is also serving as a manager and key researcher of “multi million dollars projects funded by NSF, FDA and pharmaceutical companies. He is well known in pharmaceutical systems engineering field among regulators, researchers and pharmaceutical manufacturing practitioners for his work related to pharmaceutical process monitoring and control, simulation, optimization, QbD, PAT, and novel methods and software tools development. He is highly experienced on pharmaceutical systems engineering as well as practical implementation into the plant.

Dr. Singh’s educational background was also based on Pharmaceutical system engineering field of Chemical and Biochemical Engineering. He obtained his MS from IIT Roorkee India and completed his MS thesis from Process System Engineering center, RWTH Aachen Germany on modelling and control of crystallization process (a key unit operation used for API purification process). He has completed his PhD from CAPEC, Department of Chemical and Biochemical Engineering, Technical University of Denmark. For his PhD thesis which was based on pharmaceutical systems engineering, he received a prestigious EFCE Excellence Award given in Recognition of an Outstanding PhD Thesis, from European Federation of Chemical Engineering. In the area pf pharmaceutical system engineering, he has published more than 43 research papers, written 4 book chapters, and presented at over 75 international conferences.

On the basis of Dr. Singh’s educational and research backgrounds and publication records, he is a right person to be served as an editor and author of this book.

Affiliations and Expertise

NSF Engineering Research Center (ERC) for Structured Organic Particulate Systems (C- SOPS), Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, NJ, USA

Zhihong Yuan Editor

Zhihong Yuan received his M.Sc. from China University of Petroleum (Beijing) in 2008 before moving to Tsinghua University where he obtained his Ph.D in 2011. After working at Carnegie Mellon University as a postdoctoral researcher for almost three years, he moved to Auburn University as a postdoctoral fellow in 2014. In this September, he will be joining Tsinghua University, China as an assistant professor at the Department of Chemical Engineering.

Since 2008, Dr. Yuan has been extensively involved in several research activities in the field of process systems engineering ranging from processing unit/plant-wide

modelling, simulation, and nonlinear analysis to process synthesis/design, optimization, and control along with the extensive applications to energy systems and (petro) chemical processes.

Affiliations and Expertise

Department of Chemical, Engineering, Tsinghua University. Beijing, China