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Sterile Product Facility Design and Project Management Second Edition

Sterile Product Facility Design and Project Management  Second Edition Author Jeffrey N. Odum
ISBN-10 9781420025859
Release 2004-03-29
Pages 392
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Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.



Good Design Practices for GMP Pharmaceutical Facilities Second Edition

Good Design Practices for GMP Pharmaceutical Facilities  Second Edition Author Terry Jacobs
ISBN-10 9781315355023
Release 2016-08-18
Pages 536
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This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.



Sterile Drug Products

Sterile Drug Products Author Michael J. Akers
ISBN-10 9781420020564
Release 2016-04-19
Pages 516
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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.



Process Architecture in Biomanufacturing Facility Design

Process Architecture in Biomanufacturing Facility Design Author Jeffery Odum
ISBN-10 9781118833650
Release 2018-01-26
Pages 384
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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.



Downstream Industrial Biotechnology

Downstream Industrial Biotechnology Author Michael C. Flickinger
ISBN-10 9781118618981
Release 2013-07-17
Pages 872
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An affordable, easily accessible desk reference on biomanufacturing, focused on downstream recovery and purification Advances in the fundamental knowledge surrounding biotechnology, novel materials, and advanced engineering approaches continue to be translated into bioprocesses that bring new products to market at a significantly faster pace than most other industries. Industrial scale biotechnology and new manufacturing methods are revolutionizing medicine, environmental monitoring and remediation, consumer products, food production, agriculture, and forestry, and continue to be a major area of research. The downstream stage in industrial biotechnology refers to recovery, isolation, and purification of the microbial products from cell debris, processing medium and contaminating biomolecules from the upstream process into a finished product such as biopharmaceuticals and vaccines. Downstream process design has the greatest impact on overall biomanufacturing cost because not only does the biochemistry of different products ( e.g., peptides, proteins, hormones, antibiotics, and complex antigens) dictate different methods for the isolation and purification of these products, but contaminating byproducts can also reduce overall process yield, and may have serious consequences on clinical safety and efficacy. Therefore downstream separation scientists and engineers are continually seeking to eliminate, or combine, unit operations to minimize the number of process steps in order to maximize product recovery at a specified concentration and purity. Based on Wiley's Encyclopedia of Industrial Biotechnology: Bioprocess, Bioseparation, and Cell Technology, this volume features fifty articles that provide information on down- stream recovery of cells and protein capture; process development and facility design; equipment; PAT in downstream processes; downstream cGMP operations; and regulatory compliance. It covers: Cell wall disruption and lysis Cell recovery by centrifugation and filtration Large-scale protein chromatography Scale down of biopharmaceutical purification operations Lipopolysaccharide removal Porous media in biotechnology Equipment used in industrial protein purification Affinity chromatography Antibody purification, monoclonal and polyclonal Protein aggregation, precipitation and crystallization Freeze-drying of biopharmaceuticals Biopharmaceutical facility design and validation Pharmaceutical bioburden testing Regulatory requirements Ideal for graduate and advanced undergraduate courses on biomanufacturing, biochemical engineering, biophar- maceutical facility design, biochemistry, industrial microbiology, gene expression technology, and cell culture technology, Downstream Industrial Biotechnology is also a highly recommended resource for industry professionals and libraries.



Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities Author Terry Jacobs
ISBN-10 9780849398537
Release 2005-06-10
Pages 576
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A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.



Manufacturing of Pharmaceutical Proteins

Manufacturing of Pharmaceutical Proteins Author Stefan Behme
ISBN-10 9783527683093
Release 2015-02-13
Pages 440
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Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.



American Book Publishing Record

American Book Publishing Record Author
ISBN-10 UOM:39015066043186
Release 2003
Pages
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American Book Publishing Record has been writing in one form or another for most of life. You can find so many inspiration from American Book Publishing Record also informative, and entertaining. Click DOWNLOAD or Read Online button to get full American Book Publishing Record book for free.



The British National Bibliography

The British National Bibliography Author Arthur James Wells
ISBN-10 UOM:39015066099238
Release 2006
Pages
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The British National Bibliography has been writing in one form or another for most of life. You can find so many inspiration from The British National Bibliography also informative, and entertaining. Click DOWNLOAD or Read Online button to get full The British National Bibliography book for free.



Systems Thinking

Systems Thinking Author Jamshid Gharajedaghi
ISBN-10 0123859166
Release 2011-08-09
Pages 376
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Systems Thinking, Third Edition combines systems theory and interactive design to provide an operational methodology for defining problems and designing solutions in an environment increasingly characterized by chaos and complexity. This new edition has been updated to include all new chapters on self-organizing systems as well as holistic, operational, and design thinking. The book covers recent crises in financial systems and job markets, the housing bubble, and environment, assessing their impact on systems thinking. A companion website is available at interactdesign.com. This volume is ideal for senior executives as well as for chief information/operating officers and other executives charged with systems management and process improvement. It may also be a helpful resource for IT/MBA students and academics. Four NEW chapters on self-organizing systems, holistic thinking, operational thinking, and design thinking Covers the recent crises in financial systems and job markets globally, the housing bubble, and the environment, assessing their impact on systems thinking Companion website to accompany the book is available at interactdesign.com



Handbook of Farm Dairy and Food Machinery Engineering

Handbook of Farm  Dairy and Food Machinery Engineering Author Myer Kutz
ISBN-10 9780123858825
Release 2013-06-10
Pages 760
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Handbook of Farm, Dairy and Food Machinery Engineering is the essential reference for engineers who need to understand those aspects of the food industry from farm machinery to food storage facilities to the machinery that processes and packages our foods. The process of getting food from "farm to fork," as the saying goes, involves more than planting, harvesting, shipping, processing, packaging and distributing—though those are all key components. Effective and efficient food delivery systems are built around processes that maximize the effort while minimizing cost, time, and resource depletion. This comprehensive reference is for engineers who design and build machinery and processing equipment, shipping containers, and packaging and storage equipment. It includes cutting-edge coverage of microwave vacuum application in grain processing, cacao processing, fruit and vegetable processing, ohmic heating of meat, facility design, closures for glass containers, double seaming, and much more. Provides cross-topic information for translational research and potential application Focuses on design and controls – written for engineers by engineers – always with practical applications in mind Includes design of machinery and facilities as well as theoretical basis for determining and predicting behavior of foods as they are handled and processed



Sterilization of Drugs and Devices

Sterilization of Drugs and Devices Author WayneP. Olson
ISBN-10 9781351413831
Release 2018-03-29
Pages 576
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Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the ""how to validate"" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.



Biotechnology Operations

Biotechnology Operations Author Michael J. Roy
ISBN-10 9781439830284
Release 2011-06-27
Pages 416
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Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.



The Cumulative Book Index

The Cumulative Book Index Author
ISBN-10 UOM:39015058373732
Release 1997
Pages
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The Cumulative Book Index has been writing in one form or another for most of life. You can find so many inspiration from The Cumulative Book Index also informative, and entertaining. Click DOWNLOAD or Read Online button to get full The Cumulative Book Index book for free.



The Design of Everyday Things

The Design of Everyday Things Author Don Norman
ISBN-10 9780465072996
Release 2013-11-05
Pages 384
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The ultimate guide to human-centered design Even the smartest among us can feel inept as we fail to figure out which light switch or oven burner to turn on, or whether to push, pull, or slide a door. The fault, argues this ingenious-even liberating-book, lies not in ourselves, but in product design that ignores the needs of users and the principles of cognitive psychology. The problems range from ambiguous and hidden controls to arbitrary relationships between controls and functions, coupled with a lack of feedback or other assistance and unreasonable demands on memorization. The Design of Everyday Things shows that good, usable design is possible. The rules are simple: make things visible, exploit natural relationships that couple function and control, and make intelligent use of constraints. The goal: guide the user effortlessly to the right action on the right control at the right time. The Design of Everyday Things is a powerful primer on how--and why--some products satisfy customers while others only frustrate them.



Planning Design and Construction of Health Care Facilities

Planning  Design  and Construction of Health Care Facilities Author
ISBN-10 1599403072
Release 2009-01-01
Pages 156
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Planning, Design, and Construction of Health Care Facilities, Second Edition, an updated version of a Joint Commission Resources best seller, is a comprehensive guide for health care organizations around the world that are looking to build new facilities - or update their current structures - in compliance with Joint Commission, Joint Commission International, and other recognized standards of health care design excellence. A wealth of strategies, tools, and real-world experiences of organizations around the globe supply the reader with the building blocks they need for success with their new facility or existing structure. Planning, Design, and Construction of Health Care Facilities, Second Edition assesses the challenges, compliance issues, and the need for a holistic approach to the design and function of health care facilities; and this new edition, readers receive valuable online resources in support of the printed material, including customizable tools they can use immediately in their organization.



Biopharmaceutical Processing

Biopharmaceutical Processing Author Gunter Jagschies
ISBN-10 9780128125526
Release 2017-12-15
Pages 1308
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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