Pharmaceutical Process Scale Up Second Edition
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Pharmaceutical Process Scale Up Second Edition
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Author : Michael Levin
language : en
Publisher: CRC Press
Release Date : 2005-10-18
Pharmaceutical Process Scale Up Second Edition written by Michael Levin and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-10-18 with Medical categories.
Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated reference spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up-clearly introducing readers to the theoretical concept of dimensional analysis to quantify similar processes on varying scales.
Pharmaceutical Process Scale Up
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Author : Michael Levin
language : en
Publisher: CRC Press
Release Date : 2001-12-12
Pharmaceutical Process Scale Up written by Michael Levin and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-12-12 with Medical categories.
Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling,
Pharmaceutical Process Scale Up Third Edition
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Author : Michael Levin
language : en
Publisher: CRC Press
Release Date : 2011-02-02
Pharmaceutical Process Scale Up Third Edition written by Michael Levin and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-02 with Medical categories.
The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.
Pharmaceutical Process Engineering And Scale Up Principles
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Author : Anil B. Jindal
language : en
Publisher: Springer Nature
Release Date : 2023-07-03
Pharmaceutical Process Engineering And Scale Up Principles written by Anil B. Jindal and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-07-03 with Medical categories.
The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process. The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms. Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process. Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations. Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up. Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource for those involved in the pharmaceutical industry. Only book that is dedicated to pharmaceutical process engineering and scale-up; Contain numerous case studies for easy reference; Covers solid, liquid, and advanced dosage forms.
Pharmaceutical Process Engineering
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Author : Anthony J. Hickey
language : en
Publisher: CRC Press
Release Date : 2016-03-09
Pharmaceutical Process Engineering written by Anthony J. Hickey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-03-09 with Medical categories.
With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac
Industrial Process Scale Up
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Author : Jan Harmsen
language : en
Publisher: Elsevier
Release Date : 2019-05-16
Industrial Process Scale Up written by Jan Harmsen and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-16 with Technology & Engineering categories.
Industrial Process Scale-up: A Practical Innovation Guide from Idea to Commercial Implementation, Second Edition helps industrial process innovators in research, development and commercial start-ups assess the risks of commercial-scale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable levels. In addition, the book can be used in cooperation with industrial R&D people and academic researchers to shape open innovation programs, and in education as a reference book. This updated edition has the latest literature and has been expanded with a scale-up of pharmaceutical processes and their history in both academia and the process industries. Offers easily accessible, step-by-step and concise guidelines for industrial process scale-up Explains each stage of the innovation funnel, from research, development, demonstration and commercial implementation for any process type and branch Based on industrial experiences and practices that reduce the risks of commercial scale implementation of new processes to acceptable levels and reduce cost and time of process innovation
Industrial Process Scale Up
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Author : Jan Harmsen
language : en
Publisher: Elsevier
Release Date : 2013-04-25
Industrial Process Scale Up written by Jan Harmsen and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-04-25 with Technology & Engineering categories.
This book will help industrial process innovators in research, development and commercial start-up to assess the risks of commercial-scale implementation and provide them with practical guidelines and methods to reduce the risks to acceptable levels. The book can also be used in co-operation with industrial R&D people and academic researchers to shape open innovation programs and in education as a reference book for process innovation courses. Offers easily accessible, step-by-step, and concise guidelines for industrial process scale-up Explains each stage of the innovation funnel: research, development, demonstration, commercial implementation for any process type and branch Based on industrial experiences and practices, which reduces the risks of commercial scale implementation of new processes to acceptable levels and reduces cost and time of process innovation Very clear, attractive layout, using text boxes that contain clarifying notes and additional information on specific topics, which makes it a quick reference of main subjects and additional information
Pharmaceutical Process Validation Second Edition
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Author : Ira R. Berry
language : en
Publisher: CRC Press
Release Date : 1993-01-29
Pharmaceutical Process Validation Second Edition written by Ira R. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-01-29 with Medical categories.
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
Chemical Engineering In The Pharmaceutical Industry
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Author : Mary T. am Ende
language : en
Publisher: John Wiley & Sons
Release Date : 2019-04-09
Chemical Engineering In The Pharmaceutical Industry written by Mary T. am Ende and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-09 with Technology & Engineering categories.
A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Pharmaceutical Process Chemistry For Synthesis
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Author : Peter J. Harrington
language : en
Publisher: John Wiley & Sons
Release Date : 2011-02-23
Pharmaceutical Process Chemistry For Synthesis written by Peter J. Harrington and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-23 with Science categories.
There is a need to explain that generic versions of a drug may not be manufactured by the same process as brand-name drugs and that the different processes may have dramatically different environmental impacts. Two global forces are at odds today—the push for "greener" processes and the push for lower drug prices. This book brings this conflict into sharp focus by discussing in detail the published process chemistry for top-selling small molecule drugs. Providing insights about process route selection, choice of reagents, and reaction conditions, Pharmaceutical Process Chemistry for Synthesis guides process chemists in identifying best processes for manufacturing these blockbuster drugs as they lose patent protection. Further, it highlights the strategies and methodology that might be useful for expediting the process research and development of the blockbusters of the future. Written from a refreshingly objective perspective, this book is essential for process chemists who need to devise practical syntheses for increasingly complex drugs in a constantly decreasing time frame.