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

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 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

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