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Endotoxin Indicator Vial (>1,000 EU/vial)


Endotoxin Indicator Vial (>1,000 EU/vial)

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 at least a 3-log 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

  Download our Package Insert for Endotoxin Indicator