Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo
Original Factory Endotoxin And Bioburden Testing - 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 pursuit and company goal is to "Always satisfy our customer requirements". We continue to develop and design superior quality products for both our old and new customers and achieve a win-win prospect for our clients as well as us for Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: Turin, Greenland, Switzerland, As a way to make use of the resource on the expanding information and facts in international trade, we welcome prospects from everywhere on the web and offline. In spite in the top quality products we offer, effective and satisfying consultation service is supplied by our specialist after-sale service group. Solution lists and detailed parameters and any other info weil be sent to you timely for the inquiries. So please get in touch with us by sending us emails or contact us if you have any concerns about our firm. ou can also get our address info from our web site and come to our enterprise. or a field survey of our solutions. We're confident that we are going to share mutual results and build solid co-operation relations with our companions in this market. We're looking forward to your inquiries.
By Nelly from Cologne - 2018.07.26 16:51
We are a small company that has just started, but we get the company leader's attention and gave us a lot of help. Hope we can make progress together!
By Page from Florida - 2017.09.30 16:36
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