Process Systems Engineering for Pharmaceutical Manufacturing

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. 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.

“Process Systems Engineering for Pharmaceutical Manufacturing” is a diverse collection of reviews and case studies, most of which were published previously. While this book provides an excellent summary of process modelling and computing with a view to the increased importance of robust simulation tools in pharmaceutical process development and manufacturing, more recent journal publications may provide additional or more in-depth information on the current state of specific technologies or algorithms described in the book. It is also evident that much of the key work in these areas has yet to be done. One topic missing from discussion in the book is the advent of quantum computing and the potential quantum computing presents in solving optimisation problems in process systems engineering. I would look forward to seeing an additional volume added to the series as the technology develops" --Johnson Matthey Technology Review

• 1. New Product Discovery and Development for Pharmaceutical IndustryCatherine Azzaro-Pantel2. The development of a pharmaceutical oral solid dosage formsRahamatullah Shaikh, Denise Croker, Donal O'Brien and Gavin Walker 3. Innovative Process Development and Production Concepts for Small-molecule API ManufacturingJohn Woodley4. Plantwide Technoeconomic Analysis and Separation Solvent Selection for Continuous Pharmaceutical Manufacturing: Ibuprofen, Artemisinin and DiphenhydramineDimitrios Gerogiorgis, Samir Diab and Hikaru Jolliffe 5. Flowsheet Modeling of a Continuous Direct Compression ProcessSeongkyu Yoon6. Plant-wide Dynamic Model for the Integrated Continuous Pharmaceutical Process: Design of the RecycleBrahim Benyahia7. Advanced Multi-phase Hybrid Model Development of Fluidized Bed Wet Granulation ProcessesRohit Ramachandran, Ashutosh Tamrakar and Dheeraj R. Devarampally 8. Global sensitivity, feasibility and flexibility analysis of continuous pharmaceutical manufacturing processesMarianthi Ierapetritou and Zilong Wang 9. Crystallization process monitoring and control using process analytical technologyLevente Simon, Elena Simone and Kaoutar Abbou Oucherif 10. BioProcess Performance Monitoring using Multi-way Interval Partial Least SquareJulian Morris, Jie Zhang and Shallon Stubbs 11. Process Dynamics, and control of API manufacturing and purification processeMaitraye Sen, Ravendra Singh and Rohit Ramachandran 12. PAT for pharmaceutical manufacturing process involving solid dosages formsAndrés 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 Singh14. Fast Stochastic Model Predictive Control of End-to-end Continuous Pharmaceutical ManufacturingRichard D. Braatz, Ali Mesbah, Joel A. Paulson, Stefan Streif and Rolf Findeisen 15. Advanced Control for the Continuous Dropwise Additive Manufacturing of Pharmaceutical ProductsZoltan 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 Lakerveld17. Automation of continuous pharmaceutical manufacturing processRavendra Singh18. Implementation of control system into continuous pharmaceutical manufacturing pilot-plant (powder to tablet)Ravendra Singh19. Monitoring and control of a continuous tumble mixerCarlos Velazquez Figueroa, Leonel Quiñones and Miguel A. Florian Algarin 20. Flexible Continuous Manufacturing -- Based on S88 Batch Standards and Object Oriented DesignPaul Brodbeck21. Planning Pharmaceutical Clinical Trials under Outcome UncertaintySelen Cremaschi and Brianna Christian 22. Integrated production planning and inventory management in a multinational pharmaceutical supply chainNaresh Susarla and IA Karimi 23. Optimal Production of Biopharmaceutical ManufacturingLazaros Papageorgiou and Songsong Liu 24. Perspective on PSE in pharmaceutical process development and innovation-views from academiaRafiqul Gani, John Woodley and Emmanouil Papadakis