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Industrial Process Scale-up

Industrial Process Scale-up
  • Author : Jan Harmsen
  • Publisher :Unknown
  • Release Date :2013-04-25
  • Total pages :112
  • ISBN : 9780444627391
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Summary : 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

Industrial Process Scale-Up

Industrial Process Scale-Up
  • Author : Jan Harmsen
  • Publisher :Unknown
  • Release Date :2013
  • Total pages :116
  • ISBN : 044462726X
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Summary : 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

Scale-up Methodology for Chemical Processes

Scale-up Methodology for Chemical Processes
  • Author : Jean-Paul Euzen,Pierre Trambouze,Jean-Pierre Wauquier
  • Publisher :Unknown
  • Release Date :1993
  • Total pages :240
  • ISBN : 2710806460
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Summary : 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.

Pharmaceutical Process Scale-Up, Third Edition

Pharmaceutical Process Scale-Up, Third Edition
  • Author : Michael Levin
  • Publisher :Unknown
  • Release Date :2011-02-02
  • Total pages :530
  • ISBN : 1616310014
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Summary : 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.

Process Understanding

Process Understanding
  • Author : Ian Houson
  • Publisher :Unknown
  • Release Date :2011-06-09
  • Total pages :370
  • ISBN : 9783527637164
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Summary : 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.

Scaleup and Design of Industrial Mixing Processes

Scaleup and Design of Industrial Mixing Processes
  • Author : Gary B. Tatterson
  • Publisher :Unknown
  • Release Date :2003
  • Total pages :392
  • ISBN : 0972663517
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Summary : Mistakes in process scaleup can be costly. This text is a comprehensive and highly practical source to all types of mixing and scaleup issues.

Chemical Projects Scale Up

Chemical Projects Scale Up
  • Author : Joe M. Bonem
  • Publisher :Unknown
  • Release Date :2018-05-31
  • Total pages :232
  • ISBN : 9780128137284
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Summary : 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

Scale-up in Chemical Engineering

Scale-up in Chemical Engineering
  • Author : Marko Zlokarnik
  • Publisher :Unknown
  • Release Date :2006-08-21
  • Total pages :296
  • ISBN : 9783527607761
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Summary : 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.

Process Scale Bioseparations for the Biopharmaceutical Industry

Process Scale Bioseparations for the Biopharmaceutical Industry
  • Author : Abhinav A. Shukla,Mark R. Etzel,Shishir Gadam
  • Publisher :Unknown
  • Release Date :2006-07-07
  • Total pages :575
  • ISBN : 9781420016024
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Summary : The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.

Scaleup of Chemical Processes

Scaleup of Chemical Processes
  • Author : Attilio Bisio,Bisio,Robert Lynn Kabel,Robert L. Kabel
  • Publisher :Unknown
  • Release Date :1985-07-25
  • Total pages :699
  • ISBN : UOM:39015010893249
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Summary : The focus of this book is on the technical factors that are critical to th e design and startup of a commercial manufacturing facility.

Food Processing Operations and Scale-up

Food Processing Operations and Scale-up
  • Author : Kenneth J. Valentas,J. Peter Clark,Leon Levin
  • Publisher :Unknown
  • Release Date :2020-08-12
  • Total pages :408
  • ISBN : 9781000147568
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Summary : 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,

Pharmaceutical Process Scale-Up

Pharmaceutical Process Scale-Up
  • Author : Michael Levin
  • Publisher :Unknown
  • Release Date :2001-12-12
  • Total pages :584
  • ISBN : 9780824741969
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Summary : 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, granulation and drying, fluid bed applications, compaction and tableting, and film coating and regulatory requirements for scale-up and postapproval changes. Drawing on the experience of twenty contributing researchers, the book employs dimensional analysis as a unified scientific approach to quantify similar processes on different scales.

Scaling Chemical Processes

Scaling Chemical Processes
  • Author : Jonathan Worstell
  • Publisher :Unknown
  • Release Date :2016-10-27
  • Total pages :186
  • ISBN : 9780128047699
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Summary : Scaling Chemical Processes: Practical Guides in Chemical Engineering is one of a series of short texts that each provides a focused introductory view on a single subject. The full library spans the main topics in the chemical process industries for engineering professionals who require a basic grounding in various related topics. They are ‘pocket publications’ that the professional engineer can easily carry with them or access electronically while working. Each text is highly practical and applied, and presents first principles for engineers who need to get up to speed in a new area fast. The focused facts provided in each guide will help you converse with experts in the field, attempt your own initial troubleshooting, check calculations, and solve rudimentary problems. This book discusses scaling chemical processes from a laboratory through a pilot plant to a commercial plant. It bases scaling on similarity principles and uses dimensional analysis to derive the dimensionless parameters necessary to ensure a successful chemical process development program. This series is fully endorsed and co-branded by the IChemE, and they help to promote the series. Offers practical, short, concise information on the basics to help you get an answer or teach yourself a new topic quickly Includes industry examples to help you solve real world problems Provides key facts for professionals in convenient single subject volumes Discusses scaling chemical processes from a laboratory through a pilot plant to a commercial plant

The Pilot Plant Real Book

The Pilot Plant Real Book
  • Author : Francis X. McConville
  • Publisher :Unknown
  • Release Date :2006-12-01
  • Total pages :320
  • ISBN : 0972176926
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Summary :

Practical Process Research and Development – A guide for Organic Chemists

Practical Process Research and Development – A guide for Organic Chemists
  • Author : Neal G. Anderson
  • Publisher :Unknown
  • Release Date :2012-05-23
  • Total pages :488
  • ISBN : 9780123865380
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Summary : 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

Protein Chromatography

Protein Chromatography
  • Author : Giorgio Carta,Alois Jungbauer
  • Publisher :Unknown
  • Release Date :2020-06-02
  • Total pages :432
  • ISBN : 9783527346660
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Summary : 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.

Pharmaceutical Process Scale-Up, Second Edition

Pharmaceutical Process Scale-Up, Second Edition
  • Author : Michael Levin
  • Publisher :Unknown
  • Release Date :2005-10-18
  • Total pages :576
  • ISBN : 1574448765
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Summary : 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.

Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology

Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology
  • Author : Alexandru Mihai Grumezescu
  • Publisher :Unknown
  • Release Date :2017-12-11
  • Total pages :696
  • ISBN : 9780128136300
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Summary : Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology focuses on the fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. In particular, the following aspects of nanoparticle preparation methods are discussed: the need for less toxic reagents, simplification of the procedure to allow economic scale-up, and optimization to improve yield and entrapment efficiency. Written by a diverse range of international researchers, the chapters examine characterization and manufacturing of nanomaterials for pharmaceutical applications. Regulatory and policy aspects are also discussed. This book is a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about how nanomaterials can best be utilized. Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry

Process Chemistry in the Pharmaceutical Industry, Volume 2

Process Chemistry in the Pharmaceutical Industry, Volume 2
  • Author : Kumar Gadamasetti,Tamim Braish
  • Publisher :Unknown
  • Release Date :2007-12-10
  • Total pages :520
  • ISBN : 1420008358
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Summary : As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

Solid/Liquid Separation: Equipment Selection and Process Design

Solid/Liquid Separation: Equipment Selection and Process Design
  • Author : Steve Tarleton,Richard Wakeman
  • Publisher :Unknown
  • Release Date :2006-12-07
  • Total pages :464
  • ISBN : 0080467172
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Summary : In this volume, the third in a set specifically written for the industrial process and chemical engineer, the authors provide the detailed information on filtration equipment and media which allows the reader to then consider the pre-treatment of suspensions, selection of the most appropriate equipment for the task, data analysis and the subsequent design of the processes involved for particular separations. The result is a comprehensive book which is designed to be used frequently and referred to regularly in order to achieve better industrial separations. Successful industrial-scale separation of solids from liquids requires not only a thorough understanding of the principles involved, but also an appreciation of which equipment to use for best effect, and a start-to-finish plan for the various processes involved in the operation. If these factors are all correct, then successful separations should result. Part of 3-volume set Unique approach to industrial separations Internationally-known authors

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
  • Author : Mary T. am Ende,David J. am Ende
  • Publisher :Unknown
  • Release Date :2019-04-09
  • Total pages :688
  • ISBN : 9781119285496
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Summary : 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.