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Автор: James Agalloco, James Akers Название: Advanced Aseptic Processing Technology Издательство: CRC Press Год: 2010 ISBN: 9781439825433 Серия: Drugs and the Pharmaceutical Sciences (Book 207) Язык: English Формат: pdf Размер: 16,2 mb Страниц: 496
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on:
- The use of isolator and barrier concepts for aseptic processing and assembly. - The application of robotics as an alternative to gowned personnel. - The increasing reliance on automation to minimize or eliminate operator intervention. - The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing.
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