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Bioendo’s Endotoxin Challenge Vials (Endotoxin Indicator) is produced without excipient, and will not be carbonized under high temperature. Bioendo’s Endotoxin Challenge Vials (Endotoxin Indicator) are designed to indicate a minimum 3-log reduction. With stable potency, it could be detected with gel-clot endotoxin assay, turbidimetric endotoxin assay , or chromogenic endotoxin assay.


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 not baked Endotoxin Indicators. The Endotoxin Challenge vials are designed to indicate a minimum 3-log reduction in endotoxin content when tested using gel clot endotoxin assay kit, kinetic turbidimetric endotoxin assay kit or chromogenic Lyophilized Amebocyte Lysate assay kits. Endotoxin Challenge Vial contains 1000 to 10000EU Endotoxins level in a glass vial. ECV1250V and ECV2500V are sealed in vials that configurate the heat resistant stoppers and heat resistant 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 regulations of ANSI, AAMI, ISO, USP and FDA to ensure that all items that are required to be sterile or endotoxin-free are able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious micro-organism or pyrogens.

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.


The potency: 1000 to 10000 EU per vial and 2000 to 10000 EU in a vial.  


In vial with heat resistant stopper (tolerable high temperature up to 360 Celsius degree) and heat resistant label. 

In the procedure of baking or drying, ECV vial’s lid no need to remove. 

Without excipient.  

Endotoxin Challenge Vial  (10ml glass bottle and 2ml of ISO standard 2R glass bottle)

Order information

Catalog No. Endotoxins Level (EU/vial) Package
ECV1250V 1000 - 10000 In Vial, 10 Vials/Pack
ECV1250VR  1000 - 10000 ISO 2R vial, 10 Vials/Pack
ECV2500V 2000 - 10000 In Vial, 10 Vials/Pack
ECV2500VR  2000 - 10000 ISO 2R vial, 10 Vials/Pack
ECV100000V 50000 - 200000 In Vial, 10 Vials/Pack

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