Assurance of Sterility for Sensitive Combination Products and Materials : New Paradigms to Bring Innovative Healthcare Products to Patients

著者名：Lambert, Byron J. (EDT)/Lam, Stan (EDT)/Hansen, Joyce M. (EDT)/Bryans, Trabue D. (EDT)

Academic Press（2019/11/30発売）

• 言語：ENG
• ISBN：9780128050828
• eISBN：9780128131794

Description

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

Table of Contents

1. Introduction: Sterilization or aseptic processing of single use combination productsJoyce M. Hansen, and Trabue D. Bryans2. Sensitive combination products: Devices, pharmaceuticals, and biologicsAndrew L. Lewis3. Terminal sterilizationVu H. Le, Scott Weiss, Brad Lundahl, and Stan Lam4. Aseptic processingHal Baseman5. Package/container closuresThierry Wagner, Jennifer Van Mullekom, Jane Severin, and Michael H. Scholla6. Review of current practice in preventing health care associated infectionsDonna Swenson7. Risk to the patient—Quantifying assurance of sterilityMarc L. Speck, Harry Frederick Bushar, James Niederecker, and Byron J. Lambert8. Developing new productsStan Lam9. Regulatory pathway for labeling combination products as sterileTrabue D. Bryans, Eamonn Victor Hoxey, and Steven Turtil10. Path forwardByron J. Lambert, and Joyce M. Hansen