Abstract
The sterilization process is considered a fundamental requirement for the development of most single use sterile medical devices and is often viewed as nonvalue added. Simply put, it is a necessary activity that just must be done. If the sterilization process is assessed early, however, it can have a tremendous impact on a program. Optimization of the process can accelerate the development process, reducing the time to market. Understanding the interaction of the product with the sterilant may also expand the design space for research and development. This chapter explores proactive strategies for assessing the sterilization process and maps out in detail options for exploring alternative sterility assurance limits using the framework of ISO/TS 19930:2017 and the European Medicines Agency guidance.
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