INTRODUCTION

Gases, such as compressed air, nitrogen, and atmospheric gases that contact sterile components, containers and closures, and product contact surfaces of processing equipment, such as tanks and piping, must be sterile to prevent contamination of pharmaceuticals and biopharmaceuticals. The sterilization of gases is typically accomplished by passing the gas through one or more sterilizing-grade membrane filters. The filtration process must be designed to ensure that the filtered gas has been sterilized.