INTRODUCTION

The production of parenteral products requires that products be sterile, but also that they are free from harmful levels of pyrogens, or fever causing agents. For the purposes of the 〈1228〉 series, the term “depyrogenation” refers to the destruction or removal of bacterial endotoxins, the most prevalent and quantifiable pyrogen in parenteral preparations. Effective depyrogenation depends on the product and the method of removal and/or destruction. Although depyrogenation of heat-stable articles may be best accomplished by dry heat, heat-labile equipment, components, ingredients, or materials such as drug product containers and closures, and some medical devices may be depyrogenated through physical means such as rinsing. This chapter provides an overview of the depyrogenation process, its validation, and routine process control.