DEFINITION

An Endotoxin Indicator is an article (challenge vial of endotoxin or a carrier spiked with endotoxin) designed for use in depyrogenation studies. The endotoxin (a purified lipopolysaccharide) is validated for use in or on an Endotoxin Indicator. The carrier is made from a material appropriate for the intended depyrogenation processes to which it will be subjected. The endotoxin on a carrier is added at a concentration sufficient to allow recovery of a minimum of 1000 USP Endotoxin Units/carrier. The Endotoxin Indicator would allow for accurate indication of at least a 3-log reduction in USP Endotoxin Units during depyrogenation process challenges.