Introduction

The proper development and implementation of a sterilization process requires a number of important sequential steps to ensure that an appropriate sterilization process results in materials and products that are both microbiologically safe and suitable for their intended use. Sterilization technologies that rely on heat, ionizing radiation, and chemicals often have the potential to alter the physicochemical properties of materials to which they are applied. In some cases, sterilization could either leave toxic residues on materials that were sterilized or result in impurities (i.e., leachables) being more readily released into products that contact them. Thus, it is necessary to consider sterilization not only as a means of eliminating microorganisms but also as a process that has the potential to change materials in a manner that impacts usefulness, safety, or both. A balance between the microbial lethality of a sterilization process and other aspects of patient safety must be established. A robust sterilization process that satisfies both is the desired objective of the cycle development activities.