Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo


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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.  

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

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

How is the features of Bioendo’s Endotoxin Challenge Vails (Endotoxin Indicator)?

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:

Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures


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We know that we only thrive if we can easily guarantee our combined cost competiveness and high-quality advantageous at the same time for Original Factory Endotoxin And Bioburden Testing - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: Kazakhstan, New Delhi, Philippines, The working experience in the field has helped us forged a strong relations with customers and partners both in domestic and international market. For years, our products have been exported to more than 15 countries in the world and have been widely used by customers.
  • After the signing of the contract, we received satisfactory goods in a short term, this is a commendable manufacturer.
    5 Stars By Yannick Vergoz from Ukraine - 2017.06.22 12:49
    Timely delivery, strict implementation of the contract provisions of the goods, encountered special circumstances, but also actively cooperate, a trustworthy company!
    5 Stars By Madeline from Estonia - 2017.04.28 15:45

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