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Industrial Process Scale Up

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Pharmaceutical Process Scale Up Third Edition

Pharmaceutical Process Scale Up  Third Edition Book
Author : Michael Levin
Publisher : CRC Press
Release : 2011-02-02
ISBN : 9781616310011
Language : En, Es, Fr & De

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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.

Industrial Process Scale up

Industrial Process Scale up Book
Author : Jan Harmsen
Publisher : Elsevier
Release : 2019-07-15
ISBN : 9780444642103
Language : En, Es, Fr & De

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Book Description :

Industrial Process Scale-up helps industrial process innovators in research, development and commercial start-ups to assess the risks of commercial-scale implementation and provides 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. This second edition has been revised, updated with the latest literature, and expanded with scale-up of pharmaceutical processes, and the history of scale-up methods in academia and in process industries. 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

Process Understanding

Process Understanding Book
Author : Ian Houson
Publisher : John Wiley & Sons
Release : 2011-04-08
ISBN : 352763715X
Language : En, Es, Fr & De

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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.

Industrial Process Scale up

Industrial Process Scale up Book
Author : Jan Harmsen
Publisher : Elsevier
Release : 2019-05-16
ISBN : 0444642846
Language : En, Es, Fr & De

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Book Description :

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

Chemical Projects Scale Up

Chemical Projects Scale Up Book
Author : Joe M. Bonem
Publisher : Elsevier
Release : 2018-05-31
ISBN : 0128137282
Language : En, Es, Fr & De

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Book Description :

Chemical Projects Scale Up: How to Go from Laboratory to Commercial covers the chemical engineering steps necessary for taking a laboratory development into the commercial world. The book includes the problems associated with scale up, equipment sizing considerations, thermal characteristics associated with scale up, safety areas to consider, recycling considerations, operability reviews and economic viability. In addition to the process design aspects of commercializing the laboratory development, consideration is given to the utilization of a development in an existing plant. Explains how heat removal for exothermic reactions can be scaled up Outlines how a reactor can be sized from batch kinetic data Discusses how the plant performance of a new catalyst can be evaluated Presents how the economics of a new product/process can be developed Discusses the necessary evaluation of recycling in commercial plants

Scaleup of Chemical Processes

Scaleup of Chemical Processes Book
Author : Attilio Bisio,Robert Lynn Kabel,Robert L. Kabel
Publisher : Wiley-Interscience
Release : 1985-07-25
ISBN : 0987650XXX
Language : En, Es, Fr & De

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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.

Scale up in Chemical Engineering

Scale up in Chemical Engineering Book
Author : Marko Zlokarnik
Publisher : John Wiley & Sons
Release : 2006-08-21
ISBN : 3527607765
Language : En, Es, Fr & De

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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.

Pharmaceutical Process Chemistry for Synthesis

Pharmaceutical Process Chemistry for Synthesis Book
Author : Peter J. Harrington
Publisher : John Wiley & Sons
Release : 2011-02-23
ISBN : 9780470922866
Language : En, Es, Fr & De

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Book Description :

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.

Practical Process Research and Development A guide for Organic Chemists

Practical Process Research and Development     A guide for Organic Chemists Book
Author : Neal G. Anderson
Publisher : Academic Press
Release : 2012-05-23
ISBN : 0123865387
Language : En, Es, Fr & De

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Book Description :

Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights: • Reflects the current thinking in chemical process R&D for small molecules • Retains similar structure and orientation to the first edition. • Contains approx. 85% new material • Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up) • Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes) • Replaces the first edition, although the first edition contains useful older examples that readers may refer to Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more Presents guidelines for implementing and troubleshooting processes

Asymmetric Catalysis on Industrial Scale

Asymmetric Catalysis on Industrial Scale Book
Author : Hans Ulrich Blaser,Elke Schmidt
Publisher : John Wiley & Sons
Release : 2007-02-27
ISBN : 3527605770
Language : En, Es, Fr & De

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Book Description :

Edited by two of the experts in the field, the central aim is to show organic chemists working in process development that enantioselective catalysis is suitable for the large-scale production of enantioenriched intermediates. In so doing, it is equally a source of information and inspiration for academic research, and, with its contribution by Noble prizewinner W. S. Knowles, will also heighten the status of industrial catalyst specialists working in the exciting field of enantioselective catalysis. Some 25 contributions from top industrial researchers around the world present case studies on the development of the widest possible range of large-scale enantioselective processes, featuring stereoselective production processes of fine-chemicals, agrochemicals and pharmaceuticals. Clearly structured according to the nature of the task, this handbook adopts a problem-driven approach such that readers can easily find how colleagues have dealt with a similar situation.

Scale Up Processes

Scale Up Processes Book
Author : Jamal Chaouki,Rahmat Sotudeh-Gharebagh
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2021-09-20
ISBN : 3110713985
Language : En, Es, Fr & De

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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:

Manual of Industrial Microbiology and Biotechnology

Manual of Industrial Microbiology and Biotechnology Book
Author : Arnold L. Demain,Julian E. Davies,Ronald M. Atlas,Charles L. Hershberger,Gerald Cohen
Publisher : Amer Society for Microbiology
Release : 1999
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This second edition of the bestselling Manual of Industrial Microbiology and Biotechnology brings together in one place the biological and engineering methodologies required to develop a successful industrial process, from culture isolation and development to useful product. The editors have enlisted a broad range of experts, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers. This comprehensive perspective provides a valuable "how to" resource, the structure of which resembles the sequence of operations involved in the development of a commercial biological process and product.

Handbook of Process Chromatography

Handbook of Process Chromatography Book
Author : Gunter Jagschies,Gail K. Sofer,Lars Hagel
Publisher : Elsevier
Release : 2007-12-08
ISBN : 9780080554518
Language : En, Es, Fr & De

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Book Description :

This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers. Updates include: - sources and productivity - types of products made today - experiences in clinical and licensed products - economics - current status of validation - illustrations and tables - automated column packing - automated systems New topics include: - the use of disposables - multiproduct versus dedicated production - design principles for chromatography media and filters - ultrafiltration principles and optimization - risk assessments - characterization studies - design space - platform technologies - process analytical technologies (PATs) - biogenerics - comparability assessments Key Features: - new approaches to process optimiaztion - use of patform technologies - applying risk assessment to process design

Dimensional Analysis and Scale up in Chemical Engineering

Dimensional Analysis and Scale up in Chemical Engineering Book
Author : Marko Zlokarnik
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 3642766730
Language : En, Es, Fr & De

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Book Description :

Contemporary Chemical Process Engineers face complex design and research problems. Temperature-dependent physical properties and non-Newtonian flow behavior of substances in a process cannot be predicted by numerical mathematics. Scaling-up equipment for processing can often only be done with partial similarity methods. Standard textbooks often neglect topics like dimensional analysis, theory of similarity and scale-up. This book fills this gap! It is aimed both at university students and the process engineer. It presents dimensional analysis very comprehensively with illustrative examples of mechanical, thermal and chemical processes.

Food Processing Operations and Scale up

Food Processing Operations and Scale up Book
Author : Kenneth J. Valentas,J. Peter Clark,Leon Levin
Publisher : CRC Press
Release : 2020-08-12
ISBN : 1000147568
Language : En, Es, Fr & De

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Book Description :

Intended for students and practitioners who have a basic education in chemical engineering or food science. Contains basic information in each area and describes some of the fundamental ideas of processing development and design. Examines the food industry structure, how it works, consumer products,

Protein Chromatography

Protein Chromatography Book
Author : Giorgio Carta,Alois Jungbauer
Publisher : John Wiley & Sons
Release : 2020-06-02
ISBN : 352734666X
Language : En, Es, Fr & De

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Book Description :

An all-in-one practical guide on how to efficiently use chromatographic separation methods Based on a training course that teaches the theoretical as well as practical aspects of protein bioseparation to bioprocess professionals, this fully updated and revised new edition offers comprehensive coverage of continuous chromatography and provides readers with many relevant examples from the biopharmaceutical industry. Divided into two large parts, Protein Chromatography: Process Development and Scale-Up, Second Edition presents all the necessary knowledge for effective process development in chromatographic bioseparation, both on small and large scale. The first part introduces chromatographic theory, including process design principles, to enable the reader to rationalize the set-up of a bioseparation process. The second part illustrates by way of case studies and sample protocols how the theory learned in the first part may be applied to real-life problems. Chapters look at: Downstream Processing of Biotechnology Products; Chromatography Media; Laboratory and Process Columns and Equipment; Adsorption Equilibrium; Rate Processes; and Dynamics of Chromatography Columns. The book closes with chapters on: Effects of Dispersion and Rate Processes on Column Performance; Gradient Elution Chromatography; and Chromatographic Column Design and Optimization. -Presents the most pertinent examples from the biopharmaceutical industry, including monoclonal antibodies -Provides an overview of the field along with design tools and examples illustrating the advantages of continuous processing in biopharmaceutical productions -Focuses on process development and large-scale bioseparation tasks, making it an ideal guide for the professional bioengineer in the biotech and pharma industries -Offers field-tested information based on decades of training courses for biotech and chemical engineers in Europe and the U.S. Protein Chromatography: Process Development and Scale-Up, Second Edition will appeal to biotechnologists, analytical chemists, chromatographers, chemical engineers, pharmaceutical industry, biotechnological industry, and biochemists.

Bioreactors

Bioreactors Book
Author : Carl-Fredrik Mandenius
Publisher : John Wiley & Sons
Release : 2016-02-16
ISBN : 3527683380
Language : En, Es, Fr & De

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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.

Handbook of Transition Metal Polymerization Catalysts

Handbook of Transition Metal Polymerization Catalysts Book
Author : Ray Hoff
Publisher : John Wiley & Sons
Release : 2018-05-08
ISBN : 1119242134
Language : En, Es, Fr & De

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Book Description :

Including recent advances and historically important catalysts, this book overviews methods for developing and applying polymerization catalysts – dealing with polymerization catalysts that afford commercially acceptable high yields of polymer with respect to catalyst mass or productivity. • Contains the valuable data needed to reproduce syntheses or use the catalyst for new applications • Offers a guide to the design and synthesis of catalysts, and their applications in synthesis of polymers • Includes the information essential for choosing the appropriate reactions to maximize yield of polymer synthesized • Presents new chapters on vanadium catalysts, Ziegler catalysts, laboratory homopolymerization, and copolymerization

Scale up Methodology for Chemical Processes

Scale up Methodology for Chemical Processes Book
Author : Jean-Paul Euzen,Pierre Trambouze,Jean-Pierre Wauquier
Publisher : Editions TECHNIP
Release : 1993
ISBN : 9782710806462
Language : En, Es, Fr & De

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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.

Microbial Sensing in Fermentation

Microbial Sensing in Fermentation Book
Author : Satinder K. Brar,Ratul K. Das,Saurabh J. Sarma
Publisher : John Wiley & Sons
Release : 2019-01-04
ISBN : 1119247969
Language : En, Es, Fr & De

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Book Description :

A comprehensive review of the fundamental molecular mechanisms in fermentation and explores the microbiology of fermentation technology and industrial applications Microbial Sensing in Fermentation presents the fundamental molecular mechanisms involved in the process of fermentation and explores the applied art of microbiology and fermentation technology. The text contains descriptions regarding the extraordinary sensing ability of microorganisms towards small physicochemical changes in their surroundings. The contributors — noted experts in the field — cover a wide range of topics such as microbial metabolism and production (fungi, bacteria, yeast etc); refined and non-refined carbon sources; bioprocessing; microbial synthesis, responses and performance; and biochemical, molecular and extra/intracellular controlling. This resource contains a compilation of literature on biochemical and cellular level mechanisms for microbial controlled production and includes the most significant recent advances in industrial fermentation. The text offers a balanced approach between theory and practical application, and helps readers gain a clear understanding of microbial physiological adaptation during fermentation and its cumulative effect on productivity. This important book: Presents the fundamental molecular mechanisms involved in microbial sensing in relation to fermentation technology Includes information on the significant recent advances in industrial fermentation Contains contributions from a panel of highly-respected experts in their respective fields Offers a resource that will be essential reading for scientists, professionals and researchers from academia and industry with an interest in the biochemistry and microbiology of fermentation technology Written for researchers, graduate and undergraduate students from diverse backgrounds, such as biochemistry and applied microbiology, Microbial Sensing in Fermentation offers a review of the fundamental molecular mechanisms involved in the process of fermentation.