INTRODUCTION

The production of parenteral products requires not only that products be sterile, but that they are also free from harmful levels of pyrogens. Depyrogenation is defined as the direct and validated destruction or removal of pyrogens. For the purposes of this and subsequent chapters 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. The chapters in this series discuss depyrogenation procedures that are applicable to product streams, equipment, and drug product containers and closures.