Popular Design for Endotoxin Indicator For Depyrogenation - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo
Popular Design for Endotoxin Indicator For Depyrogenation - 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:
Our business puts emphasis over the administration, the introduction of talented staff, plus the construction of employees building, striving hard to boost the standard and liability consciousness of staff members. Our corporation successfully attained IS9001 Certification and European CE Certification of Popular Design for Endotoxin Indicator For Depyrogenation - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: Vancouver, Mombasa, Italy, Our staffs are rich in experience and trained strictly, with professional knowledge, with energy and always respect their customers as the No. 1, and promise to do their best to provide the effective and individual service for customers. The Company pays attention to maintaining and developing the long-term cooperation relationship with the customers. We promise, as your ideal partner, we will develop a bright future and enjoy the satisfying fruit together with you, with persisting zeal, endless energy and forward spirit.
By Laura from Angola - 2018.06.30 17:29
We always believe that the details decides the company's product quality, in this respect, the company conform our requirements and the goods are meet our expectations.
By Laura from Chile - 2018.02.12 14:52
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