Full 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.
Contents
1. Introduction: Sterilization or aseptic processing of single use combination products
Joyce M. Hansen, and Trabue D. Bryans
2. Sensitive combination products: Devices, pharmaceuticals, and biologics
Andrew L. Lewis
3. Terminal sterilization
Vu H. Le, Scott Weiss, Brad Lundahl, and Stan Lam
4. Aseptic processing
Hal Baseman
5. Package/container closures
Thierry Wagner, Jennifer Van Mullekom, Jane Severin, and Michael H. Scholla
6. Review of current practice in preventing health care associated infections
Donna Swenson
7. Risk to the patient—Quantifying assurance of sterility
Marc L. Speck, Harry Frederick Bushar, James Niederecker, and Byron J. Lambert
8. Developing new products
Stan Lam
9. Regulatory pathway for labeling combination products as sterile
Trabue D. Bryans, Eamonn Victor Hoxey, and Steven Turtil
10. Path forward
Byron J. Lambert, and Joyce M. Hansen
