China Manufacturer for Endotoxin Produced By - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo
China Manufacturer for Endotoxin Produced By - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo Detail:
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 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.
2. Product Parameter
The potency: 1000 to 10000 EU per vial and 2000 to 10000 EU in a vial.
3. Product Features and Application
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.
|
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 |
Endotoxin challenge vial, in the operation procedures, the lysate reagent has to match the ECV kit, and no need remove the lit during the baking procedure.
Product detail pictures:
Related Product Guide:
We also offer product sourcing and flight consolidation services. We have our own factory and sourcing office. We can provide you with almost every type of product related to our product range for China Manufacturer for Endotoxin Produced By - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: South Africa, Portugal, Gambia, So far our products have been exported to east Europe, the Middle East, Southeast, Africa and South America etc. We have 13years professional sales and purchase in Isuzu parts at home and abroad and the ownership of the modernized electronic Isuzu parts checking systems. We honor our core principal of Honesty in business, priority in service and will do our best to offer our customers with high quality products and excellent service.
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