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(lid).

Validation of dry heat sterilization cycle(s) is required by ANSI, AAMI, ISO, USP and the FDA to ensure that all items that are required to be sterile orpyrogen freeare able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious microorganism or pyrogen."

Follow the Regulations requirement, use Bioendo ECV is able to operate the endotoxin free validation or pyrogen free validation. More important information is Bioendo ECV no need rubber lid(cap) removal in the heating operation.

2. Product Parameter

Endotoxin potency: ≥1250 or 2500 EU per vial

3. Product Features and Application

In vial with heat resistant stopper, high temperature lid up to 360 Celius, and label. 

when drying operation, no need open rubber lid. 

None excipient.