Ravendra Singh - Process Systems Engineering for Pharmaceutical Manufacturing

Ravendra Singh, Rutgers, The State University of New Jersey, Piscataway, NJ, United States of America

The pharmaceutical industry is a global business sector with more than $1 trillion annual sales focusing on performance-based products designed to address the health care needs of the world's population. Currently, the pharmaceutical industry is experiencing a number of significant changes in its business and regulatory environments. Especially, the pharmaceutical industry is under pressure to modernize its manufacturing process and to deliver its end products with minimum time, space, cost, and resources while guaranteeing desirable quality of the products. The pharmaceutical companies are therefore going through a paradigm shift from traditional manufacturing mode to modernized mode built on cutting-edge technology and computer-aided methods and tools. Apparently, such shift can benefit tremendously from the application of methods and tools of process systems engineering (PSE). Therefore, systematic process and system engineering methods and tools are needed that can solve the problems related to pharmaceutical industry more efficiently.

This book elucidates how the PSE methods and tools help and promote the discovery, development, deployment of pharmaceutical products, and the relevant manufacturing processes. The state-of-the-art computer-aided methods and tools in PSE field have been described in different chapters that will help to modernize the pharmaceutical industry and can solve its problems more efficiently. The four interesting areas where PSE methods and tools can significantly contribute have been included. These areas are pharmaceutical product and process synthesis and design; pharmaceutical production process modeling, simulation, analysis, and optimization; pharmaceutical production process dynamics, control, monitoring, and operations; and enterprise-wide optimization and supply chain management for pharmaceutical-manufacturing processes.

Continuous manufacturing (CM) is evolving as a preferred platform for pharmaceutical products. One advantage of CM among others is that the product quality can be controlled in real time and thereby it opens the possibilities of achieving Quality by Design (QbD), Quality by Control (QbC), and real-time release (RTR) paradigms. The different types of continuous pharmaceutical manufacturing processes such as powder to tablet, drop on demand, and end-to-end continuous pharmaceutical manufacturing processes have been included. The application of PSE for continuous pharmaceutical manufacturing such as modeling, optimization, automation, sensing, and control has been systematically illustrated.

This book includes 24 chapters. The first chapter describes the new product development and supply chains in the pharmaceutical industry. The development of a pharmaceutical oral solid-dosage form has been described in .

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Crystallization process monitoring and control using process analytical technology has been described in reviews the process dynamics and control of API manufacturing and purification processes.

PAT for pharmaceutical manufacturing process involving solid dosages forms is described in .

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These chapters systematically introduce the use of PSE methods and tools for discovering, developing, deploying greener, safer, cost-effective, and efficient pharmaceutical production processes. A wide spectrum of case studies has been described where different PSE tools and methods have been used to improve various pharmaceutical production processes with distinct final products. This book will promote the applications of process system engineering for pharmaceutical manufacturing and will serve as a foundation for future research and development of this area.

Catherine Azzaro-Pantel Laboratoire de Gnie Chimique, Universit de Toulouse, CNRS, Toulouse, France