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Author: William M. (Bill) Huitt
Publisher: John Wiley & Sons
ISBN: 1119284252
Category : Technology & Engineering
Languages : en
Pages : 544
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Book Description
The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.
Author: William M. (Bill) Huitt
Publisher: John Wiley & Sons
ISBN: 1119284252
Category : Technology & Engineering
Languages : en
Pages : 544
Get Book
Book Description
The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.
Author: William Huitt
Publisher:
ISBN:
Category : Biochemical engineering
Languages : en
Pages :
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Book Description
Serving as a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explaining what lies behind many of the requirements and recommendations within that industry standard, this book shows readers why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. --
Author: Regine Eibl
Publisher: John Wiley & Sons
ISBN: 1119477778
Category : Medical
Languages : en
Pages : 672
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Book Description
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Author: CCPS (Center for Chemical Process Safety)
Publisher: John Wiley & Sons
ISBN: 1118009002
Category : Technology & Engineering
Languages : en
Pages : 244
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Book Description
This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.
Author: American Society of Mechanical Engineers
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: Pauline M. Doran
Publisher: Elsevier
ISBN: 0080528120
Category : Science
Languages : en
Pages : 455
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Book Description
The emergence and refinement of techniques in molecular biology has changed our perceptions of medicine, agriculture and environmental management. Scientific breakthroughs in gene expression, protein engineering and cell fusion are being translated by a strengthening biotechnology industry into revolutionary new products and services. Many a student has been enticed by the promise of biotechnology and the excitement of being near the cutting edge of scientific advancement. However, graduates trained in molecular biology and cell manipulation soon realise that these techniques are only part of the picture. Reaping the full benefits of biotechnology requires manufacturing capability involving the large-scale processing of biological material. Increasingly, biotechnologists are being employed by companies to work in co-operation with chemical engineers to achieve pragmatic commercial goals. For many years aspects of biochemistry and molecular genetics have been included in chemical engineering curricula, yet there has been little attempt until recently to teach aspects of engineering applicable to process design to biotechnologists. This textbook is the first to present the principles of bioprocess engineering in a way that is accessible to biological scientists. Other texts on bioprocess engineering currently available assume that the reader already has engineering training. On the other hand, chemical engineering textbooks do not consider examples from bioprocessing, and are written almost exclusively with the petroleum and chemical industries in mind. This publication explains process analysis from an engineering point of view, but refers exclusively to the treatment of biological systems. Over 170 problems and worked examples encompass a wide range of applications, including recombinant cells, plant and animal cell cultures, immobilised catalysts as well as traditional fermentation systems. * * First book to present the principles of bioprocess engineering in a way that is accessible to biological scientists * Explains process analysis from an engineering point of view, but uses worked examples relating to biological systems * Comprehensive, single-authored * 170 problems and worked examples encompass a wide range of applications, involving recombinant plant and animal cell cultures, immobilized catalysts, and traditional fermentation systems * 13 chapters, organized according to engineering sub-disciplines, are groupled in four sections - Introduction, Material and Energy Balances, Physical Processes, and Reactions and Reactors * Each chapter includes a set of problems and exercises for the student, key references, and a list of suggestions for further reading * Includes useful appendices, detailing conversion factors, physical and chemical property data, steam tables, mathematical rules, and a list of symbols used * Suitable for course adoption - follows closely curricula used on most bioprocessing and process biotechnology courses at senior undergraduate and graduate levels.
Author: Bjorn K. Lydersen
Publisher: John Wiley & Sons
ISBN: 0471035440
Category : Science
Languages : en
Pages : 837
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Book Description
Divided into four sections, the first and third reflect the fact that there are two types of equipment required in the plant--one in which the actual product is synthesized or processed such as the fermentor, centrifuge and chromatographic columns; and the other that supplies support for the facility or process including air conditioning, water and waste systems. Part two describes such components as pumps, filters and valves not limited to a certain type of equipment. Lastly, it covers planning and designing the entire facility along with requirements for containment and validation of the process.
Author:
Publisher:
ISBN:
Category : Biopharmaceutics
Languages : en
Pages : 328
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Book Description
"The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new fluid processing equipment used in the manufacture of biopharmaceuticals, where a defined level of purity and bioburden control is required."--Introduction.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309047854
Category : Science
Languages : en
Pages : 133
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Book Description
The ability of the United States to sustain a dominant global position in biotechnology lies in maintaining its primacy in basic life-science research and developing a strong resource base for bioprocess engineering and bioproduct manufacturing. This book examines the status of bioprocessing and biotechnology in the United States; current bioprocess technology, products, and opportunities; and challenges of the future and what must be done to meet those challenges. It gives recommendations for action to provide suitable incentives to establish a national program in bioprocess-engineering research, development, education, and technology transfer.
Author: Cenk Undey
Publisher: CRC Press
ISBN: 1439829454
Category : Medical
Languages : en
Pages : 330
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Book Description
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
