Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals

Byron J. Lambert’s book, “Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals,” delves into the medical device industry and the challenges associated with sensitive combination products (SCPs) and their terminal sterilization. The book reassesses current assumptions to ensure that the best interests of patients are met in the development of increasingly rigorous sterilization methods to combat MRSA and other ‘super-bugs’.

The book uniquely adopts a holistic, end-to-end approach to sterilization, focusing particularly on materials selection and product design. It introduces sterilization principles at the material selection and design stages, addressing the industry’s need for new sterilization processes for new medical devices and biomaterials. The book provides guidance on selecting the appropriate sterilization technique for newly developed sensitive combination products and examines forward-thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies.

Published by Elsevier Science on November 30, 2019, this book is a must-read for professionals in the medical device industry. It is available in English and offers comprehensive insights into the future of medical device sterilization.

ISBN: 9780128050828, 9780128131794