Handbook of Downstream Processing

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 9400915632
Total Pages : 745 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis Handbook of Downstream Processing by : E. Goldberg

Download or read book Handbook of Downstream Processing written by E. Goldberg and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 745 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?

Downstream Processing of Natural Products

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Author :
Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 384 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Downstream Processing of Natural Products by : M. S. Verrall

Download or read book Downstream Processing of Natural Products written by M. S. Verrall and published by John Wiley & Sons. This book was released on 1996-08-06 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Natural Products, broadly defined as high value chemical entities derived from plants or microbial sources, have been known and exploited for many years. In recent years, as the need for higher potency and predictability of such products has increased, more sophisticated concentration and isolation procedures have been developed. With the passage of time, such procedures have been rationalized in terms of scientific principles but, in general, theory has followed behind practice, leading at any given time to an absence from the literature of methods which are truly state of the art. Downstream Processing of Natural Products: A Practical Handbook is a highly practical manual which addresses this issue, and guides researchers and industrial workers through the many potential pitfalls of natural product isolation. The contributors to this volume, all of whom have wide practical experience in this field, present state-of-the-art techniques and observations. The three main stages of natural product purification are covered, namely product release, capture, and purification, and both proteins and secondary metabolites are covered. There is special mention of the requirements of the regulatory authorities with respect to Good Manufacturing Practice, and practical guidance is given on scale-up procedures and process scale instrumentation. Downstream Processing of Natural Products: A Practical Handbook will provide essential practical guidance to all those involved in natural product isolation. This includes academic and industrial researchers, postgraduate students and technicians working in the biotechnology field.

Handbook of Process Chromatography

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Author :
Publisher : Elsevier
ISBN 13 : 0080554512
Total Pages : 383 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Handbook of Process Chromatography by : Gunter Jagschies

Download or read book Handbook of Process Chromatography written by Gunter Jagschies and published by Elsevier. This book was released on 2007-12-08 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Handbook of Biofuels

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Publisher : Academic Press
ISBN 13 : 0128231335
Total Pages : 692 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Handbook of Biofuels by : Sanjay Sahay

Download or read book Handbook of Biofuels written by Sanjay Sahay and published by Academic Press. This book was released on 2021-10-31 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Biofuels looks at the many new developments in various type of bioenergy, along with the significant constraints in their production and/or applications. Beyond introducing current approaches and possible future directions of research, this title covers sources and processing of raw materials to downstream processing, constraints involved and research approaches to address and overcome these needs. Different combinations of products from the biorefinery are included, along with the material to answer questions surrounding the optimum process conditions for conversion of different feedstocks to bioenergy, the basis for choosing conversion technology, and what bioenergy products make economic sense. With chapters on the techno-economic analysis of biofuel production and concepts and step-by-step approaches in bioenergy processing, the objective of this book is to present a comprehensive and all-encompassing reference about bioenergy to students, teachers, researchers and professionals. Reviews all existing and emerging technologies surrounding the production of advanced biofuels, including biodiesel and bioethanol Includes biofuel applications with compatible global application case studies Offers new pathways for converting biomass

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1351675699
Total Pages : 673 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Filtration and Purification in the Biopharmaceutical Industry, Third Edition by : Maik W. Jornitz

Download or read book Filtration and Purification in the Biopharmaceutical Industry, Third Edition written by Maik W. Jornitz and published by CRC Press. This book was released on 2019-06-26 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Protein Chromatography

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Publisher : John Wiley & Sons
ISBN 13 : 352734666X
Total Pages : 440 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Protein Chromatography by : Giorgio Carta

Download or read book Protein Chromatography written by Giorgio Carta and published by John Wiley & Sons. This book was released on 2020-06-02 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Handbook of Microalgal Culture

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Publisher : John Wiley & Sons
ISBN 13 : 1405172495
Total Pages : 587 pages
Book Rating : 4.4/5 (51 download)

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Book Synopsis Handbook of Microalgal Culture by : Amos Richmond

Download or read book Handbook of Microalgal Culture written by Amos Richmond and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 587 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Microalgal Culture is truly a landmarkpublication, drawing on some 50 years of worldwide experience inmicroalgal mass culture. This important book comprisescomprehensive reviews of the current available information onmicroalgal culture, written by 40 contributing authors from aroundthe globe. The book is divided into four parts, with Part I detailingbiological and environmental aspects of microalgae with referenceto microalgal biotechnology and Part II looking in depth at majortheories and techniques of mass cultivation. Part III compriseschapters on the economic applications of microalgae, includingcoverage of industrial production, the use of microalgae in humanand animal nutrition and in aquaculture, in nitrogen fixation,hydrogen and methane production, and in bioremediation of pollutedwater. Finally, Part IV looks at new frontiers and includeschapters on genetic engineering, microalgae as platforms forrecombinant proteins, bioactive chemicals, heterotrophicproduction, microalgae as gene-delivery systems for expressingmosquitocidal toxins and the enhancement of marine productivity forclimate stabilization and food security. Handbook of Microalgal Culture is an essential purchasefor all phycologists and also those researching aquatic systems,aquaculture and plant sciences. There is also much of great use toresearchers and those involved in product formulation withinpharmaceutical, nutrition and food companies. Libraries in alluniversities and research establishments teaching and researchingin chemistry, biological and pharmaceutical sciences, food sciencesand nutrition, and aquaculture will need copies of this book ontheir shelves. Amos Richmond is at the Blaustein Institute for DesertResearch, Ben-Gurion University of the Negev, Israel.

Handbook of Natural Gas Transmission and Processing

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Author :
Publisher : Gulf Professional Publishing
ISBN 13 : 0123869145
Total Pages : 830 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Handbook of Natural Gas Transmission and Processing by : Saeid Mokhatab

Download or read book Handbook of Natural Gas Transmission and Processing written by Saeid Mokhatab and published by Gulf Professional Publishing. This book was released on 2012-07-02 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique, well-documented, and forward-thinking work, the second edition of Handbook of Natural Gas Transmission and Processing continues to present a thoroughly updated, authoritative, and comprehensive description of all major aspects of natural gas transmission and processing. It provides an ideal platform for engineers, technologists, and operations personnel working in the natural gas industry to get a better understanding of any special requirements for optimal design and operations of natural gas transmission pipelines and processing plants. First book of its kind that covers all aspects of natural gas transmission and processing Provides pivotal updates on the latest technologies, which have not been addressed in-depth in any existing books Offers practical advice for design and operation based on sound engineering principles and established techniques Examines ways to select the best processing route for optimal design of gas-processing plants Contains new discussions on process modeling, control, and optimization in gas processing industry

Unit Operation Downstream Processing (Penerbit USM)

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Author :
Publisher : Penerbit USM
ISBN 13 : 9674612874
Total Pages : 208 pages
Book Rating : 4.6/5 (746 download)

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Book Synopsis Unit Operation Downstream Processing (Penerbit USM) by : Husnul Azan Tajarudin

Download or read book Unit Operation Downstream Processing (Penerbit USM) written by Husnul Azan Tajarudin and published by Penerbit USM. This book was released on 2018 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides fundamental principles, terminology, mechanisms, methods, types and applications of unit operation in downstream processing of various fields, ranging from engineering, technology, pure sciences and applied sciences. The discussion revolves around the principle of unit operations such as filtration, coagulation and flocculation, centrifugation, cell disruption, adsorption, chromatography, distillation, crystallization and drying. This book is designed to serve as a reference book for students, researchers, professionals and others who work in the processing industries.

Biopharmaceutical Processing

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Publisher : Elsevier
ISBN 13 : 0128125527
Total Pages : 1310 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biopharmaceutical Processing by : Gunter Jagschies

Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Handbook on Protein Purification

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Author :
Publisher :
ISBN 13 : 9781536143652
Total Pages : 0 pages
Book Rating : 4.1/5 (436 download)

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Book Synopsis Handbook on Protein Purification by : Nikolaos E. Labrou

Download or read book Handbook on Protein Purification written by Nikolaos E. Labrou and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteins are important biomolecules that are vital for the cellular structure and function. They perform a vast array of functions within organisms, including the catalysis of metabolic reactions, DNA replication, response to stimuli, and transporting molecules from one location to another. The technological advances in the omics areas (e.g., genomics, transcriptomics, proteomics, metagenomics, etc.) have dramatically increased the rate of discovering new proteins. Some of them hold large opportunities for innovative research and the development of commercial products and applications. It is worth noting that the global protein ingredients market is poised to grow over the next decade to reach approximately 58.49 billion USD by 2022, with the protein therapeutics market valuing around USD 315.9 billion by 2025. Interestingly, about seventy monoclonal antibody products will be on the market by 2020 with a combined worldwide sales of about 125 billion USD.The most significant parameter for the successful commercial exploitation of proteins rely on the development of an efficient and effective isolation and purification technology, known as protein downstream processing. Downstream processing refers to the technology that involves the isolation and production of purified products from natural sources such as animal tissues, plant tissues, microorganisms or fermentation broth. The most important element of this technology is the high purification processes, most important of which is chromatography and in particular affinity chromatography.This book provides information on the resent developments of protein downstream processing and deals with the information gained over the last years from the application of protein purification technologies on different research areas. Each chapter gives key examples that cover a wide range of diverse scientific disciplines in order to provide the reader with a representative sample of the current status of the field. The present book would definitely be an ideal source of scientific information to the advanced students, junior researchers, and scientists involved in cellular and molecular biology, biochemistry, microbiology, biotechnology and other related areas.

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1439850933
Total Pages : 535 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals, Third Edition by : Anurag S. Rathore

Download or read book Process Validation in Manufacturing of Biopharmaceuticals, Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

A Biotech Manager's Handbook

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Publisher : Elsevier
ISBN 13 : 1908818158
Total Pages : 414 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis A Biotech Manager's Handbook by : M O'Neill

Download or read book A Biotech Manager's Handbook written by M O'Neill and published by Elsevier. This book was released on 2012-05-02 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development

Handbook of Ceramics Grinding and Polishing

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Author :
Publisher : William Andrew
ISBN 13 : 1455778591
Total Pages : 501 pages
Book Rating : 4.4/5 (557 download)

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Book Synopsis Handbook of Ceramics Grinding and Polishing by : Ioan D. Marinescu

Download or read book Handbook of Ceramics Grinding and Polishing written by Ioan D. Marinescu and published by William Andrew. This book was released on 2015-11-19 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Ceramics Grinding and Polishing meets the growing need in manufacturing industries for a clear understanding of the latest techniques in ceramics processing. The properties of ceramics make them very useful as components—they withstand high temperatures and are durable, resistant to wear, chemical degradation, and light. In recent years the use of ceramics has been expanding, with applications in most industry sectors that use machined parts, especially where corrosion-resistance is required, and in high temperature environments. However, they are challenging to produce and their use in high-precision manufacturing often requires adjustments to be made at the micro and nano scale. This book helps ceramics component producers to do cost-effective, highly precise machining. It provides a thorough grounding in the fundamentals of ceramics—their properties and characteristics—and of the abrasive processes used to manipulate their final shape as well as the test procedures vital for success. The second edition has been updated throughout, with the latest developments in technologies, techniques, and materials. The practical nature of the book has also been enhanced; numerous case studies illustrating how manufacturing (machining) problems have been handled are complemented by a highly practical new chapter on the selection and efficient use of machine tools. Provides readers with experience-based insights into complex and expensive processes, leading to improved quality control, lower failure rates, and cost savings Covers the fundamentals of ceramics side-by-side with processing issues and machinery selection, making this book an invaluable guide for downstream sectors evaluating the use of ceramics, as well as those involved in the manufacturing of structural ceramics Numerous case studies from a wide range of applications (automotive, aerospace, electronics, medical devices)

Handbook of Physical Vapor Deposition (PVD) Processing

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Author :
Publisher : Cambridge University Press
ISBN 13 : 0080946585
Total Pages : 947 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Handbook of Physical Vapor Deposition (PVD) Processing by : D. M. Mattox

Download or read book Handbook of Physical Vapor Deposition (PVD) Processing written by D. M. Mattox and published by Cambridge University Press. This book was released on 2014-09-19 with total page 947 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers all aspects of physical vapor deposition (PVD) process technology from the characterizing and preparing the substrate material, through deposition processing and film characterization, to post-deposition processing. The emphasis of the book is on the aspects of the process flow that are critical to economical deposition of films that can meet the required performance specifications. The book covers subjects seldom treated in the literature: substrate characterization, adhesion, cleaning and the processing. The book also covers the widely discussed subjects of vacuum technology and the fundamentals of individual deposition processes. However, the author uniquely relates these topics to the practical issues that arise in PVD processing, such as contamination control and film growth effects, which are also rarely discussed in the literature. In bringing these subjects together in one book, the reader can understand the interrelationship between various aspects of the film deposition processing and the resulting film properties. The author draws upon his long experience with developing PVD processes and troubleshooting the processes in the manufacturing environment, to provide useful hints for not only avoiding problems, but also for solving problems when they arise. He uses actual experiences, called ""war stories"", to emphasize certain points. Special formatting of the text allows a reader who is already knowledgeable in the subject to scan through a section and find discussions that are of particular interest. The author has tried to make the subject index as useful as possible so that the reader can rapidly go to sections of particular interest. Extensive references allow the reader to pursue subjects in greater detail if desired. The book is intended to be both an introduction for those who are new to the field and a valuable resource to those already in the field. The discussion of transferring technology between R&D and manufacturing provided in Appendix 1, will be of special interest to the manager or engineer responsible for moving a PVD product and process from R&D into production. Appendix 2 has an extensive listing of periodical publications and professional societies that relate to PVD processing. The extensive Glossary of Terms and Acronyms provided in Appendix 3 will be of particular use to students and to those not fully conversant with the terminology of PVD processing or with the English language.

Filters and Filtration Handbook

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Publisher :
ISBN 13 :
Total Pages : 848 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Filters and Filtration Handbook by : T. Christopher Dickenson

Download or read book Filters and Filtration Handbook written by T. Christopher Dickenson and published by . This book was released on 1992 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a reference manual for the selection and application of filtration and separation products. The new edition is extended and updated to incorporate all the latest developments in filtration and separation technology supplied by both manufacturers and users. operators, consultants, as well as staff with responsibility for purchasing, planning, sales and marketing. It is directly relevant to numerous industries including water, fluid power, chemicals, pharmaceutical, food and beverages, processing, general engineering, electronics and manufacturing.

Process Chromatography

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Author :
Publisher : Academic Press
ISBN 13 : 1483289176
Total Pages : 89 pages
Book Rating : 4.4/5 (832 download)

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Book Synopsis Process Chromatography by : Gail K. Sofer

Download or read book Process Chromatography written by Gail K. Sofer and published by Academic Press. This book was released on 2015-09-02 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry.This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification and validation, including an overview of analytical techniques commonly used in the validation of processes. A concluding section comments on product changeover and presents four case studies.