INTRODUCTION

Sterilization processes are developed for the elimination of viable microorganisms while preserving the essential physical, chemical, and biological properties of the materials subjected to them. Where this cannot be accomplished by the sterilization methods described in Sterilization of Compendial Articles 〈1229〉, it may be possible to sterilize by using a proposed method not commonly used. When doing so, it is the end user's responsibility to demonstrate that the proposed new method can be used safely and effectively.