Assurance of Sterility for Sensitive Combination Products and Materials

The medical device industry is facing a difficult challenge between the development of the exciting new world of sensitive combination products (SCPs) and the terminal sterilization of these devices. Traditional sterilization technologies, validation methodologies and regulatory frameworks that have worked well for more than three decades do not meet the current challenges for these new classes of products. Aseptic processing of the devices is an effective proven solution for processes requiring little intervention, such as aseptic fill of vials, but is inherently difficult to control for complex manufacturing processes like solid material combination products. This book reassesses the current assumptions, the logic and the regulatory paradigms to assure the patient’s best interests are met. This is in the context of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs', and the special challenges faced with implantable medical devices, sterilization requirements and methods increasingly need to be a central concern in 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. The book will also seek to frame the issues toward a more reasonable path forward. The need is there for a discussion on the definition of sterility; with novel sterilization technologies, validation methodologies, breakthroughs in material compatibility, systematic assessment on the interactions between device-sterilization modalities and broad interdisciplinary frameworks for assurance of sterility are also required to move the industry forward. This book will provide practical guidance to those designing and implementing medical devices and sterilization regimes Introduces sterilization principles at the material selection and design stagesAddresses the industry need for new sterilization processes for new medical devices and BiomaterialsProvides guidance to select the appropriate sterilization technique for newly developed sensitive combination productsLooks forward in matching new developments in material compatibility with possible regulatory and QSR strategies