Assurance of Sterility for Sensitive Combination Products and Materials

Authored by Byron J. Lambert, this book delves into the medical device industry, focusing on the challenges associated with sensitive combination products (SCPs) and their terminal sterilization. It reassesses current assumptions to ensure that patient interests are prioritized in the development of rigorous sterilization methods, particularly in combating MRSA and other ‘super-bugs’.

The book uniquely adopts a holistic approach to sterilization, emphasizing material selection and product design. It introduces sterilization principles at the early stages of material selection and design, addressing the industry’s need for new sterilization processes for innovative medical devices and biomaterials.

Guidance is provided on selecting the appropriate sterilization technique for newly developed sensitive combination products. The book also explores forward-thinking strategies for matching new developments in material compatibility with possible regulatory and QSR strategies.

Key Features:

• 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

Published by: Elsevier Science, November 30, 2019

Language: English

ISBN: 9780128050828, 9780128131794