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

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 the difficult challenge it faces with regard to developments in 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. This book reassesses the current assumptions, the logic, and the regulatory paradigms 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 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 productsExamines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies INDICE: 1. Introduction/Scope: Sterilization or aseptic processing of single use combination products 2. Sensitive Combination Products; Devices, Pharmaceuticals and Biologics 3. Terminal Sterilization 4. Aseptic Processing 5. Package / Container Closures 6. Review of current practices in the surgical suite 7. Risk to the patient 8. Developing new products 9. Regulatory pathway for sterile labelling 10. Path Forward

• ISBN: 978-0-12-805082-8
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 252
• Fecha Publicación: 01/11/2017
• Nº Volúmenes: 1
• Idioma: Inglés