Endotoxin Challenge Vials (Endotoxin Indicator)
1. Product information
The Endotoxin Challenge Vial (ECV，Endotoxin Indicator) is used in the validation of dry heat depyrogenation cycles. In various size of vials and ampoules to fit your production lines. Suitable for kinetic turbidimetric, kinetic chromogenic, end-point chromogenic and gel clot method. Conforms to USP pharmacopoeia requirements. Endotoxin Challenge Vials are placed in the cold spots of the dry heat oven. After cycle completion, the log reduction in endotoxin levels can be determined by comparing the endotoxin levels in the baked vs non-baked control Endotoxin Indicators.
The Endotoxin Challenge vials are designed to indicate endotoxin, and used in depyrogenation process challenges allow for accurate indication of at least a 3-log reduction in Endotoxin Units (USP <1211>).
Endotoxin Challenge Vial contains 1000-10000 EU E.Coli O111:B4 Endotoxin. The endotoxin challenge vial does not have any fillers except purified endotoxin, so the vials appear empty.
2. Product parameter
Endotoxin potency: ≥1250 EU per vial