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.
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.
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Substantially revising and updating the classic reference in the field, this handbook offers a valuable overview and myriad details on current chemical processes, products, and practices. No other source offers as much data on the chemistry, engineering, economics, and infrastructure of the industry. The Handbook serves a spectrum of individuals, from those who are directly involved in the chemical industry to others in related industries and activities. It provides not only the underlying science and technology for important industry sectors, but also broad coverage of critical supporting topics. Industrial processes and products can be much enhanced through observing the tenets and applying the methodologies found in chapters on Green Engineering and Chemistry (specifically, biomass conversion), Practical Catalysis, and Environmental Measurements; as well as expanded treatment of Safety, chemistry plant security, and Emergency Preparedness. Understanding these factors allows them to be part of the total process and helps achieve optimum results in, for example, process development, review, and modification. Important topics in the energy field, namely nuclear, coal, natural gas, and petroleum, are covered in individual chapters. Other new chapters include energy conversion, energy storage, emerging nanoscience and technology. Updated sections include more material on biomass conversion, as well as three chapters covering biotechnology topics, namely, Industrial Biotechnology, Industrial Enzymes, and Industrial Production of Therapeutic Proteins.
Biological safety and biosecurity protocols are essential to the reputation and responsibility of every scientific institution, whether research, academic, or production. Every risk—no matter how small—must be considered, assessed, and properly mitigated. If the science isn't safe, it isn't good. Now in its fifth edition, Biological safety: Principles and Practices remains the most comprehensive biosafety reference. Led by editors Karen Byers and Dawn Wooley, a team of expert contributors have outlined the technical nuts and bolts of biosafety and biosecurity within these pages. This book presents the guiding principles of laboratory safety, including: the identification, assessment, and control of the broad variety of risks encountered in the lab; the production facility; and, the classroom. Specifically, Biological Safety covers protection and control elements—from biosafety level cabinets and personal protection systems to strategies and decontamination methods administrative concerns in biorisk management, including regulations, guidelines, and compliance various aspects of risk assessment covering bacterial pathogens, viral agents, mycotic agents, protozoa and helminths, gene transfer vectors, zooonotic agents, allergens, toxins, and molecular agents as well as decontamination, aerobiology, occupational medicine, and training A resource for biosafety professionals, instructors, and those who work with pathogenic agents in any capacity, Biological safety is also a critical reference for laboratory managers, and those responsible for managing biohazards in a range of settings, including basic and agricultural research, clinical laboratories, the vivarium, field study, insectories, and greenhouses.
This book reviews the assessment of industrial biotechnology products and processes from a sustainable perspective. Industrial Biotechnology is a comparably young field which comes along with high expectations with regard to sustainability issues. These stem from the promise of reducing greenhouse gas emissions and replacing fossil resources in the near or later future and using green technology, i.e. more environmentally friendly technologies. The intended economic, ecological and social benefits, however, need to be proven, resulting in a variety of challenges, both from a methodological and application point of view. In this book, specific assessment and application topics of industrial biotechnology are addressed, highlighting challenges and solutions for both developers and users of assessment methods. In twelve chapters, experts in their particular fields define the scope, characterize industrial biotechnology and show in their contributions the state of the art, challenges and prospects of assessing industrial biotechnology products and processes. The chapter 'Societal and Ethical Aspects of Industrial Biotechnology' of this book is available open access under a CC BY 4.0 license at link.springer.com
Learn how to assess and prevent biosecurity threats to protect public health and national security With contributions from experts in all facets of biosecurity, this book explains the fundamental elements of biosecurity as well as the related concepts of biosafety and biosurety, detailing how all three concepts fit within the framework of biodefense. Readers are then given the tools needed to assess and prevent biosecurity threats and vulnerabilities. The book explores the nature of biosecurity threats to research laboratories as well as to agriculture, food, and mass transit. Moreover, readers will learn how to apply principles of biosecurity to assess epidemics and protect public health. Biosecurity takes a detailed look at today's biosecurity policy, explaining how it is likely to evolve given current and potential threats to national security. The authors stress the importance of education and advocacy, helping readers develop effective programs to build public awareness and preparedness. The book also presents a novel tool to assess the effectiveness of laboratory biosafety and biosecurity programs. Biosecurity is divided into four parts: Part I: An Introduction to Biosecurity Part II: Elements of Biosecurity Part III: Biosecurity in Various Sectors Part IV: Biosecurity Policy, Bioterrorism, and the Future This book will instill a deep understanding of what biosecurity is and what it is not. It urges readers to think about the importance of biosecurity as it relates to national security, safety, and health. By exposing major flaws in global biosecurity thinking, Biosecurity sets forth a clear pathway to correct those errors and build stronger biosecurity programs.
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
This first edition of the Canadian Biosafety Standards and Guidelines (CBSG) is a harmonized national standard for the handling and storing of human and terrestrial animal pathogens and toxins in Canada. The CBSG is the result of a joint initiative undertaken by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) to update and harmonize existing Canadian biosafety standards and guidelines. It is intended to facilitate compliance by incorporating risk-, evidence- and, where possible, performance-based biosafety and biosecurity requirements, and by streamlining the requirements for handling or storing human or terrestrial animal pathogens and toxins into a single national reference document.
Examines the concept of aging process facilities and infrastructure in high hazard industries and highlights options for dealing with the problem while addressing safety issues This book explores the many ways in which process facilities, equipment, and infrastructure might deteriorate upon continuous exposure to operating and climatic conditions. It covers the functional and physical failure modes for various categories of equipment and discusses the many warning signs of deterioration. Dealing with Aging Process Facilities and Infrastructure also explains how to deal with equipment that may not be safe to operate. The book describes a risk-based strategy in which plant leaders and supervisors can make more informed decisions on aging situations and then communicate them to upper management effectively. Additionally, it discusses the dismantling and safe removal of facilities that are approaching their intended lifecycle or have passed it altogether. Filled with numerous case studies featuring photographs to illustrate the positive and negative experiences of others who have dealt with aging facilities, Dealing with Aging Process Facilities and Infrastructure covers the causes of equipment failures due to aging and their consequences; plant management commitment and responsibility; inspection and maintenance practices for managing life cycle; specific aging asset integrity management practices; and more. Describes symptoms and causal mechanisms of aging in various categories of process equipment Presents key considerations for making informed risk-based decisions regarding the repair or replacement of aging process facilities and infrastructure Discusses practices for managing process facility and infrastructure life cycle Includes examples and case histories of failures related to aging Dealing with Aging Process Facilities and Infrastructure is an important book for industrial practitioners who are often faced with the challenge of managing process facilities and infrastructure as they approach the end of their useful lifecycle.
