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. 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 a minimum 3-log reduction in endotoxin content when tested using gel clot, kinetic turbidimetric or chromogenic Lyophilized Amebocyte Lysate assays. Endotoxin Challenge Vial contains 1000-10000EU Endotoxin. ECV1250V and ECV2500V are sealed in vials with heat resistant stoppers and labels, which could be placed in dry-heat oven or dry-heat tunnel without removal of stoppers and caps.
2. Product Parameter
Endotoxin potency: ≥1250 or 2500 EU per vial
3. Product Features and Application
In vial with heat resistant stopper, cap, and label.
In ampoulescould be place into the oven without opening the ampoule.
None excipient.
