Wholesale depyrogenation is a 3-log reduction in endotoxin content - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo
Wholesale depyrogenation is a 3-log reduction in endotoxin content - 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 personnel are always in the spirit of "continuous improvement and excellence", and with the superior quality products, favorable price and good after-sales services, we try to win every customer's trust for Wholesale depyrogenation is a 3-log reduction in endotoxin content - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: South Korea, Dubai, Sri Lanka, Our products are widely sold to Europe, USA, Russia, UK, France, Australia, Middle East, South America, Africa, and Southeast Asia, etc. Our solutions are highly recognized by our customers from all around the world. And our company is committed to continually improving effectiveness of our management system to maximize customer satisfaction. We sincerely hope to make progress with our customers and create a win-win future together. Welcome to join us for business!
By Henry stokeld from Iraq - 2017.06.29 18:55
As an international trading company, we have numerous partners, but about your company, I just want to say, you are really good, wide range, good quality, reasonable prices, warm and thoughtful service, advanced technology and equipment and workers have professional training, feedback and product update is timely, in short, this is a very pleasant cooperation, and we look forward to the next cooperation!
By Elma from The Swiss - 2018.09.29 13:24
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