Manufacturing Companies for Bacteria Endotoxin Test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo


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Manufacturing Companies for Bacteria Endotoxin Test - 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:

Manufacturing Companies for Bacteria Endotoxin Test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Manufacturing Companies for Bacteria Endotoxin Test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Manufacturing Companies for Bacteria Endotoxin Test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Manufacturing Companies for Bacteria Endotoxin Test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures


Related Product Guide:

The corporation keeps to the operation concept "scientific management, superior quality and performance primacy, consumer supreme for Manufacturing Companies for Bacteria Endotoxin Test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: Washington, venezuela, Greenland, Now, with the development of internet, and the trend of internationalization, we have decided to extend business to overseas market. With the propose of bringing more profits to oversea customers by providing directly abroad. So we have changed our mind, from home to abroad, hope to give our customers more profit, and looking forward to more chance to make business.
  • The factory workers have a good team spirit, so we received high quality products fast, in addition, the price is also appropriate, this is a very good and reliable Chinese manufacturers.
    5 Stars By Abigail from Nairobi - 2018.06.19 10:42
    The product manager is a very hot and professional person, we have a pleasant conversation, and finally we reached a consensus agreement.
    5 Stars By June from Paris - 2017.07.07 13:00

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