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Название: Guide to Microbiological Control in Pharmaceuticals and Medical Devices
Авторы: Denyer S.P. (ed.), Baird R.M. (ed.)
This new edition covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing and licence application stages involved with the production of pharmaceuticals, while expanding the book's focus to include medical devices. This work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores monitoring microbiological quality, the preservation of pharmaceutical formulations and principles of sterilization, including microbiological specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity testing, and the evaluation of contamination risks in clean rooms.