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Informationen zum Autor GARY PRAGER has a bachelor's degree in chemical engineering and a master's degree in nuclear engineering from the University of New Mexico. He is a Fellow of the American Institute of Chemical Engineers (AIChE). His pharmaceutical experience includes employment with Wyeth Pharmaceuticals, Fisher Scientific, and Skanska USA. Mr. Prager also has significant nuclear engineering and environmental engineering experience with firms such as PSE&G, the Graver Company, SAIC and Kaiser Engineers. He is also the Director of the Pharmaceutical Engineering Workshop presented at the New Jersey Institute of Technology and AIChE National Meetings in Salt Lake City and Philadelphia. Klappentext A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and designEngineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience--until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing.Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings.* Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire* Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry* Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering* Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineeringPractical Pharmaceutical Engineering is an indispensable "tool of the trade" for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals. Zusammenfassung This book provides professionals in the pharmaceutical industries a basic understanding of the key elements of pharmaceutical and biotech manufacturing and design. Inhaltsverzeichnis Preface xiii 1 US Regulations for the Pharmaceutical Industries 1 1.1 Introduction 1 1.2 The FDA: Formation of a Regulatory Agency 2 1.3 FDA's Seven Program Centers and Their Responsibility 6 1.3.1 Center for Biologics Evaluation and Research 6 1.3.2 Center for Drug Evaluation and Research 6 1.3.3 Center for Devices and Radiological Health 6 1.3.4 Center for Food Safety and Applied Nutrition 6 1.3.5 Center for Veterinary Medicine 6 1.3.6 Office of Combinational Pro...
