Chapter 1 - Introduction: Sterilization or aseptic processing of single use combination products

Abstract

New patient treatment options continue to drive the need for the development of combination products. Sterility assurance innovation is critical to bring these combination products to market. This innovation requires sterility assurance professionals to collaborate across the broad spectrum of the demands of the health-care industry. Not only does a successful sterility assurance professional need to be an expert in their field, but also they need to be aware of the broad challenges and opportunities associated with bringing a combination product to the market. This book provides an overview as well as introduces exciting new opportunities in each industry sector. The sectors addressed include combination products and their design, terminal sterilization, aseptic processing, packaging, health-care practices as well as the worldwide regulatory environment. The topics associated with each sector are introduced with the perspective of facilitating the development of innovative new combination products.