Intended Use: The Endotoxin indicator is intended for performing validation for depyrogenation processes of dry heat oven cycles. To ensure that a cycle is effectively inactivating and/or destroying endotoxin, an analysis comparing the endotoxin concentration before and after the depyrogenation process is completed.
The United States Pharmacopeia (USP) describes preparing endotoxin indicators of a sufficient concentration to allow recovery of a minimum 1,000 Endotoxin Units (EU) in order to accurately demonstrate appropriate reduction in endotoxin levels during the depyrogenation process challenge.
The Endotoxin indicator is intended to demonstrate a minimum 3-log reduction after depyrogenation when used with PYROSTAR™ ES-F series by gel clot and kinetic methods.