Assurance of Sterility for Sensitive Combination Products and Materials

Book excerpt: Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. - Introduces sterilization principles at the material selection and design stages - Addresses the industry need for new sterilization processes for new medical devices and biomaterials - Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products - Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies