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Sterile Product Facility Design And Project Management Second Edition

Author: Jeffrey N. Odum
Publisher: CRC Press
ISBN: 1420025856
Size: 73.69 MB
Format: PDF, Docs
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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

Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1315355027
Size: 72.38 MB
Format: PDF, ePub
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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

Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Size: 30.31 MB
Format: PDF, ePub, Docs
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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

Author: Jeffery Odum
Publisher: John Wiley & Sons
ISBN: 1118833651
Size: 33.68 MB
Format: PDF, ePub, Mobi
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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.

The Design Of Everyday Things

Author: Norman Don
Publisher: Vahlen
ISBN: 3800648105
Size: 15.95 MB
Format: PDF, ePub, Docs
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Apple, Audi, Braun oder Samsung machen es vor: Gutes Design ist heute eine kritische Voraussetzung für erfolgreiche Produkte. Dieser Klassiker beschreibt die fundamentalen Prinzipien, um Dinge des täglichen Gebrauchs umzuwandeln in unterhaltsame und zufriedenstellende Produkte. Don Norman fordert ein Zusammenspiel von Mensch und Technologie mit dem Ziel, dass Designer und Produktentwickler die Bedürfnisse, Fähigkeiten und Handlungsweisen der Nutzer in den Vordergrund stellen und Designs an diesen angepasst werden. The Design of Everyday Things ist eine informative und spannende Einführung für Designer, Marketer, Produktentwickler und für alle an gutem Design interessierten Menschen. Zum Autor Don Norman ist emeritierter Professor für Kognitionswissenschaften. Er lehrte an der University of California in San Diego und der Northwest University in Illinois. Mitte der Neunzigerjahre leitete Don Norman die Advanced Technology Group bei Apple. Dort prägte er den Begriff der User Experience, um über die reine Benutzbarkeit hinaus eine ganzheitliche Erfahrung der Anwender im Umgang mit Technik in den Vordergrund zu stellen. Norman ist Mitbegründer der Beratungsfirma Nielsen Norman Group und hat unter anderem Autohersteller von BMW bis Toyota beraten. „Keiner kommt an Don Norman vorbei, wenn es um Fragen zu einem Design geht, das sich am Menschen orientiert.“ Brand Eins 7/2013 „Design ist einer der wichtigsten Wettbewerbsvorteile. Dieses Buch macht Spaß zu lesen und ist von größter Bedeutung.” Tom Peters, Co-Autor von „Auf der Suche nach Spitzenleistungen“