Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing

1st Edition - March 15, 2018

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  • Editors: Ravendra Singh, Zhihong Yuan
  • eBook ISBN: 9780444639660
  • Hardcover ISBN: 9780444639639

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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

Table of Contents

  • 1. New Product Discovery and Development for Pharmaceutical Industry
    Catherine Azzaro-Pantel
    2. The development of a pharmaceutical oral solid dosage forms
    Rahamatullah Shaikh, Denise Croker, Donal O'Brien and Gavin Walker
    3. Innovative Process Development and Production Concepts for Small-molecule API Manufacturing
    John Woodley
    4. Plantwide Technoeconomic Analysis and Separation Solvent Selection for Continuous Pharmaceutical Manufacturing: Ibuprofen, Artemisinin and Diphenhydramine
    Dimitrios Gerogiorgis, Samir Diab and Hikaru Jolliffe
    5. Flowsheet Modeling of a Continuous Direct Compression Process
    Seongkyu Yoon
    6. Plant-wide Dynamic Model for the Integrated Continuous Pharmaceutical Process: Design of the Recycle
    Brahim Benyahia
    7. Advanced Multi-phase Hybrid Model Development of Fluidized Bed Wet Granulation Processes
    Rohit Ramachandran, Ashutosh Tamrakar and Dheeraj R. Devarampally
    8. Global sensitivity, feasibility and flexibility analysis of continuous pharmaceutical manufacturing processes
    Marianthi Ierapetritou and Zilong Wang
    9. Crystallization process monitoring and control using process analytical technology
    Levente Simon, Elena Simone and Kaoutar Abbou Oucherif
    10. BioProcess Performance Monitoring using Multi-way Interval Partial Least Square
    Julian Morris, Jie Zhang and Shallon Stubbs
    11. Process Dynamics, and control of API manufacturing and purification processe
    Maitraye Sen, Ravendra Singh and Rohit Ramachandran
    12. PAT for pharmaceutical manufacturing process involving solid dosages forms
    Andrés David Román-Ospino, Carlos Alberto Ortega-Zuniga, Vanessa Cardenas and Ravendra Singh
    13. Model-based control system design and evaluation for continuous tablet manufacturing processes (via direct compaction, via roller compaction, via wet granulation)
    Ravendra Singh
    14. Fast Stochastic Model Predictive Control of End-to-end Continuous Pharmaceutical Manufacturing
    Richard D. Braatz, Ali Mesbah, Joel A. Paulson, Stefan Streif and Rolf Findeisen
    15. Advanced Control for the Continuous Dropwise Additive Manufacturing of Pharmaceutical Products
    Zoltan Nagy, Gintaras Reklatis and Elcin Icten
    16. Control System Implementation and Plant-Wide Control of Continuous Pharmaceutical Manufacturing Pilot Plant (End-To-End Manufacturing Process)
    Richard Lakerveld
    17. Automation of continuous pharmaceutical manufacturing process
    Ravendra Singh
    18. Implementation of control system into continuous pharmaceutical manufacturing pilot-plant (powder to tablet)
    Ravendra Singh
    19. Monitoring and control of a continuous tumble mixer
    Carlos Velazquez Figueroa, Leonel Quiñones and Miguel A. Florian Algarin
    20. Flexible Continuous Manufacturing -- Based on S88 Batch Standards and Object Oriented Design
    Paul Brodbeck
    21. Planning Pharmaceutical Clinical Trials under Outcome Uncertainty
    Selen Cremaschi and Brianna Christian
    22. Integrated production planning and inventory management in a multinational pharmaceutical supply chain
    Naresh Susarla and IA Karimi
    23. Optimal Production of Biopharmaceutical Manufacturing
    Lazaros Papageorgiou and Songsong Liu
    24. Perspective on PSE in pharmaceutical process development and innovation-views from academia
    Rafiqul Gani, John Woodley and Emmanouil Papadakis

Product details

  • No. of pages: 698
  • Language: English
  • Copyright: © Elsevier 2018
  • Published: March 15, 2018
  • Imprint: Elsevier
  • eBook ISBN: 9780444639660
  • Hardcover ISBN: 9780444639639

About the Editors

Ravendra Singh

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

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

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