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Author: Jamal Chaouki
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110713985
Category : Technology & Engineering
Languages : en
Pages : 350
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Book Description
Common scale-up methods are conventional where the blind piloting is essential. This imposes huge investment and leads to failures mostly in solid processing. However, the limitations of resources, current shortcomings, short time-to-market demand are forced companies to minimize piloting. With these situations in mind, current digitalization outlook and computational facilities, we proposed and developed a novel iterative scale up method with case studies which highly expedites the process innovation through the following key sequences:
Author: Jamal Chaouki
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110713985
Category : Technology & Engineering
Languages : en
Pages : 350
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Book Description
Common scale-up methods are conventional where the blind piloting is essential. This imposes huge investment and leads to failures mostly in solid processing. However, the limitations of resources, current shortcomings, short time-to-market demand are forced companies to minimize piloting. With these situations in mind, current digitalization outlook and computational facilities, we proposed and developed a novel iterative scale up method with case studies which highly expedites the process innovation through the following key sequences:
Author: Jan Harmsen
Publisher: Elsevier
ISBN: 0444627391
Category : Technology & Engineering
Languages : en
Pages : 129
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Book Description
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
Author: Marko Zlokarnik
Publisher: John Wiley & Sons
ISBN: 3527607765
Category : Science
Languages : en
Pages : 296
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Book Description
Covering the important task of the scale-up of processes from the laboratory to the production scale, this easily comprehensible and transparent book is divided into two sections. The first part details the theoretical principles, introducing the subject for readers without a profound prior knowledge of mathematics. It discusses the fundamentals of dimensional analysis, the treatment of temperature-dependent and rheological material values and scale-up where model systems or not available or only partly similar. All this is illustrated by 20 real-world examples, while 25 exercises plus solutions new to this edition practice and monitor learning. The second part presents the individual basic operations and covers the fields of mechanical, thermal, and chemical process engineering with respect to dimensional analysis and scale-up. The rules for scale-up are given and discussed for each operation. Other additions to this second edition are dimensional analysis of pelleting processes, and a historical overview of dimensional analysis and modeling, while all the chapters have been updated to take the latest literature into account. Written by a specialist with more than 40 years of experience in the industry, this book is specifically aimed at students as well as practicing engineers, chemists and process engineers already working in the field.
Author: Jean-Paul Euzen
Publisher: Editions TECHNIP
ISBN: 9782710806462
Category : Science
Languages : en
Pages : 266
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Book Description
Having gained considerable experience in process development at the Institut FranCais du PEtrole, the authors present a design framework, a review of the available means of investigation, and several examples illustrating their methodology of industrial process scale up. The salient feature of the book is the fact that it addresses a subject which is vital in view of its economic repercussions, yet relatively unknown in technical and scientific circles, due to the confidentiality surrounding it.Contents: 1. Main guidelines of the methodology. 2. Various types of model. 3. Pilot plants and mock-ups. 4. Experimental techniques. 5. Applications to industrial process development. 6. Conclusions. References. Index.
Author: Ian Houson
Publisher: John Wiley & Sons
ISBN: 3527637168
Category : Science
Languages : en
Pages : 370
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Book Description
Process Understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA`s Food and Drug Administration. This book covers the multidisciplinary aspects required for successful process design, safety, modeling, scale-up, PAT, pilot plant implementation, plant design as well the rapidly expanding area of outsourcing. In discussing what process understanding means to different disciplines and sectors throughout a product`s life cycle, this handbook and ready reference reveals the factors important to the development and manufacture of chemicals. The book focuses on the fundamental scientific understanding necessary. for a smoother technical transfer between the disciplines, leading to more effective and effi cient process development and manufacturing. A range of case studies are used to exemplify and illustrate the main issues raised. As a result, readers will appreciate that process understanding can deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry. This book serves as an aid to meeting the stringent regulations required by the relevant authorities through demonstrable understanding of the underlying science.
Author: Michael Levin
Publisher: CRC Press
ISBN: 9781616310011
Category : Medical
Languages : en
Pages : 0
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Book Description
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.
Author: Attilio Bisio
Publisher: Wiley-Interscience
ISBN:
Category : Science
Languages : en
Pages : 760
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Book Description
The focus of this book is on the technical factors that are critical to th e design and startup of a commercial manufacturing facility.
Author: Mary T. am Ende
Publisher: John Wiley & Sons
ISBN: 111928550X
Category : Technology & Engineering
Languages : en
Pages : 1435
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Book Description
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.
Author: Jens Nielsen
Publisher: Springer
ISBN: 1461507677
Category : Technology & Engineering
Languages : en
Pages : 537
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Book Description
This is the second edition of the text "Bioreaction Engineering Principles" by Jens Nielsen and John Villadsen, originally published in 1994 by Plenum Press (now part of Kluwer). Time runs fast in Biotechnology, and when Kluwer Plenum stopped reprinting the first edition and asked us to make a second, revised edition we happily accepted. A text on bioreactions written in the early 1990's will not reflect the enormous development of experimental as well as theoretical aspects of cellular reactions during the past decade. In the preface to the first edition we admitted to be newcomers in the field. One of us (JV) has had 10 more years of job training in biotechnology, and the younger author (IN) has now received international recognition for his work with the hottest topics of "modem" biotechnology. Furthermore we are happy to have induced Gunnar Liden, professor of chemical reaction engineering at our sister university in Lund, Sweden to join us as co-author of the second edition. His contribution, especially on the chemical engineering aspects of "real" bioreactors has been of the greatest value. Chapter 8 of the present edition is largely unchanged from the first edition. We wish to thank professor Martin Hjortso from LSU for his substantial help with this chapter.
Author: Carl-Fredrik Mandenius
Publisher: John Wiley & Sons
ISBN: 3527683372
Category : Science
Languages : en
Pages : 520
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Book Description
In this expert handbook both the topics and contributors are selected so as to provide an authoritative view of possible applications for this new technology. The result is an up-to-date survey of current challenges and opportunities in the design and operation of bioreactors for high-value products in the biomedical and chemical industries. Combining theory and practice, the authors explain such leading-edge technologies as single-use bioreactors, bioreactor simulators, and soft sensor monitoring, and discuss novel applications, such as stem cell production, process development, and multi-product reactors, using case studies from academia as well as from industry. A final section addresses the latest trends, including culture media design and systems biotechnology, which are expected to have an increasing impact on bioreactor design. With its focus on cutting-edge technologies and discussions of future developments, this handbook will remain an invaluable reference for many years to come.
