Assurance of Sterility for Sensitive Combination Products and Materials

Download or read book Assurance of Sterility for Sensitive Combination Products and Materials written by Byron J. Lambert and published by Academic Press. This book was released on 2019-11-30 with total page 266 pages. Available in PDF, EPUB and Kindle. 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.