| Author | : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen |
| Publisher | : John Wiley & Sons |
| Release Date | : 2017-09-05 |
| ISBN 10 | : 1119001323 |
| Pages | : 620 pages |
10.7.3 State of Control
| Author | : John D. Hedengren,Logan Beal |
| Publisher | : MDPI |
| Release Date | : 2018-04-13 |
| ISBN 10 | : 3038428051 |
| Pages | : 174 pages |
This book is a printed edition of the Special Issue "Combined Scheduling and Control" that was published in Processes
| Author | : Zoltan K Nagy,Arwa El Hagrasy,Jim Litster |
| Publisher | : Springer Nature |
| Release Date | : 2020-06-10 |
| ISBN 10 | : 3030415244 |
| Pages | : 541 pages |
Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.
| Author | : Ravendra Singh,Zhihong Yuan |
| Publisher | : Elsevier |
| Release Date | : 2018-03-16 |
| ISBN 10 | : 0444639667 |
| Pages | : 698 pages |
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. 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
| Author | : Ajit S. Narang,Sherif I.F. Badawy |
| Publisher | : Academic Press |
| Release Date | : 2018-08-31 |
| ISBN 10 | : 0323481035 |
| Pages | : 890 pages |
Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment
| Author | : Preetanshu Pandey,Rahul Bharadwaj |
| Publisher | : Woodhead Publishing |
| Release Date | : 2016-09-26 |
| ISBN 10 | : 0081001800 |
| Pages | : 464 pages |
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
| Author | : Pravin P. Shah |
| Publisher | : New York : McGraw-Hill |
| Release Date | : 1981 |
| ISBN 10 | : |
| Pages | : 575 pages |
| Author | : Dilip M. Parikh |
| Publisher | : CRC Press |
| Release Date | : 2016-04-19 |
| ISBN 10 | : 1616310030 |
| Pages | : 676 pages |
The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re
| Author | : N.A |
| Publisher | : N.A |
| Release Date | : 2003 |
| ISBN 10 | : |
| Pages | : 329 pages |
| Author | : Dejan Djuric |
| Publisher | : Cuvillier Verlag |
| Release Date | : 2008 |
| ISBN 10 | : 3867276439 |
| Pages | : 104 pages |
| Author | : Sarwar Beg,Md Saquib Hasnain |
| Publisher | : Academic Press |
| Release Date | : 2019-03-27 |
| ISBN 10 | : 0128163720 |
| Pages | : 448 pages |
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies
| Author | : Dao Guo Yang,Tian Long Gu,Huai Ying Zhou,Jian Min Zeng,Zheng Yi Jiang |
| Publisher | : Trans Tech Publications Ltd |
| Release Date | : 2011-02-21 |
| ISBN 10 | : 3038135828 |
| Pages | : 3094 pages |
This work brings together the latest applications of, and advances in, CAD/CAM/CAE, energy storage and energy development, mining machinery manufacturing, new energy equipment and manufacturing, cloud manufacturing and extreme manufacturing, bio-manufacturing, enterprise informationization, integrated manufacturing systems, quality monitoring and control of manufacturing processes, measurement control technologies and intelligent systems, embedded systems, etc. This broad overview of the latest advances also provides a reference source for researchers in this field.