Guidelines for Process Safety in Bioprocess Manufacturing Facilities PDF Download
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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: CCPS (Center for Chemical Process Safety)
Publisher: John Wiley & Sons
ISBN: 1118009002
Category : Technology & Engineering
Languages : en
Pages : 244
Get Book Here
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: CCPS (Center for Chemical Process Safety)
Publisher: John Wiley & Sons
ISBN: 0470251492
Category : Technology & Engineering
Languages : en
Pages : 244
Get Book Here
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: Warren C. Hyer
Publisher: ASTM International
ISBN: 0803112645
Category : Biotechnology
Languages : en
Pages : 167
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Book Description
Author: MA. Foglesong
Publisher:
ISBN:
Category : Bioprocessing
Languages : en
Pages : 6
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Book Description
The experience of Eli Lilly and Co. has demonstrated that large-scale bioprocessing can be conducted under conditions that provide safety for the fermentation operator as well as the environment. Thirty years of medical surveillance of workers associated with large-scale bioprocessing has shown no increased incidence of morbidity or mortality associated with these processes. Over 100 000 h of experience with large-scale recombinant DNA fermentations has demonstrated that, with proper design and validation criteria, genetically engineered microorganisms can be developed and the operation scaled to efficient and economical processes with excellent protection to the environment and the operating personnel. Large-scale mammalian cell culture processes, which possess their own unique set of bio-safety issues, are being developed with safeguards that ensure the use of well-characterized cell lines, the inactivation of process streams, and the elimination of risk to the bioprocess operators.
Author: C. H. Collins
Publisher: Elsevier
ISBN: 1483102149
Category : Technology & Engineering
Languages : en
Pages : 268
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Book Description
Safety in Industrial Microbiology and Biotechnology reviews the hazards involved in work with both naturally occurring and genetically-modified microorganisms. This text is divided into 12 chapters and begins with an overview of the laboratory- and industry-associated infection hazards. The subsequent chapters deal with the legal issues, containment, risk assessment, and pathogenicity testing of infection related to industrial microbiology and biotechnology. These topics are followed by discussions of the safety considerations in recombinant plasmid preparation, the safe handling of industrially-produced mammalian cells, and some genetic designs that can be applied to processes based on recombinant DNA microorganisms. Other chapters explore the design for safety in bioprocessing and the containment in the development and manufacture of recombinant DNA-derived products. The remaining chapters look into the monitoring and validation in biotechnological processes, as well as the occupational health implications of industrial biotechnology. This book will prove useful to biotechnologists, microbiologists, safety engineers, and researchers.
Author: G. Stacey
Publisher: Springer Science & Business Media
ISBN: 940114916X
Category : Science
Languages : en
Pages : 257
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Book Description
It is now more than half a century since animal cells first came into regular use in the laboratory. Instances of laboratory acquired infection and con tamination of therapeutic products, derived from the use of animal cell cultures are rare. The use of animal cells, in addition to an established role in the production of vaccines and therapeutic proteins, has many new medical applications including gene therapy, tissue engineering and cell therapy. Furthermore, C;ldvances in molecular and cell biology are enabling rapid development and application of these technologies and the development of new and more sensitive methods, such as nucleic acid amplification, for the characterisation of cells and the detection of adven titious agents. However, it is clear that there is no room for complacency in this field and the recent expansion in the use of animal cells in the manufacture of medical products and the development of new biological assays for diagnostic and pharmaco-toxicological screening, underlines the need for vigilance regarding the correct and safe use of animal cells as substrates. This book is therefore very timely and should prove to be a highly valuable text, finding a wider audience beyond those with respon sibility for laboratory safety. The book guides the reader from fundamental cell biology issues and the establishment of new in vitro methods, through testing and validation of cell lines and on to issues in the use of animal cells in manufacturing processes.
Author: Shijie Liu
Publisher: Newnes
ISBN: 0444595228
Category : Technology & Engineering
Languages : en
Pages : 1001
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Book Description
Bioprocess Engineering involves the design and development of equipment and processes for the manufacturing of products such as food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials. It also deals with studying various biotechnological processes. "Bioprocess Kinetics and Systems Engineering" first of its kind contains systematic and comprehensive content on bioprocess kinetics, bioprocess systems, sustainability and reaction engineering. Dr. Shijie Liu reviews the relevant fundamentals of chemical kinetics-including batch and continuous reactors, biochemistry, microbiology, molecular biology, reaction engineering, and bioprocess systems engineering- introducing key principles that enable bioprocess engineers to engage in the analysis, optimization, design and consistent control over biological and chemical transformations. The quantitative treatment of bioprocesses is the central theme of this book, while more advanced techniques and applications are covered with some depth. Many theoretical derivations and simplifications are used to demonstrate how empirical kinetic models are applicable to complicated bioprocess systems. Contains extensive illustrative drawings which make the understanding of the subject easy Contains worked examples of the various process parameters, their significance and their specific practical use Provides the theory of bioprocess kinetics from simple concepts to complex metabolic pathways Incorporates sustainability concepts into the various bioprocesses
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1466585749
Category : Medical
Languages : en
Pages : 746
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Book Description
Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.
Author: Dieter Behrens
Publisher:
ISBN: 9780895739247
Category : Biotechnology
Languages : en
Pages : 548
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Book Description
Author: P. Hambleton
Publisher: Springer Science & Business Media
ISBN: 9401113521
Category : Science
Languages : en
Pages : 317
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Book Description
As an industry, biotechnology may be likened to the Hymn Book, being both ancient and modern. Whereas activities such as baking, brewing, the fermenting of foods date from our earliest attempts to control and utilise the environment, the application of recombinant DNA technology is recognised as being at the forefront of novel industrial development. Perhaps because of its association with processing foodstuffs together with the benefits derived from applications in the early organic chemistry and pharmaceutical industries, biotechnology has been regarded as being inherently safe. Yet unlike other modern industries, such as chemical and nuclear, where regulation has followed from incidents or accidents, modern biotechnology has been subject to close scrutiny and regulation almost from its inception. The process of regulation itself is somewhat unusual in that it was initially self-imposed by the very scientists who developed the fundamental techniques of recombinant DNA technology. They recognised the signific ance of their development but were concerned of the effects on humans and the environment of uncontrolled application of the new, powerful technology. Concern about the possible consequences of genetic manipula tion has undoubtedly been the driving force behind the regulations that are now in place in many parts of the world and which are the subject of this book. Safety issues in the biotechnology industry can be categorised under three headings: worker, environmental and consumer (product) safety.
