Professional China bacterial endotoxin test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo


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Professional China bacterial 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:

Professional China bacterial endotoxin test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Professional China bacterial endotoxin test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Professional China bacterial endotoxin test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures

Professional China bacterial endotoxin test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo detail pictures


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We have been also concentrating on enhancing the things management and QC method so that we could preserve terrific edge inside the fiercely-competitive enterprise for Professional China bacterial endotoxin test - Endotoxin Challenge Vials (Endotoxin Indicator) – Bioendo , The product will supply to all over the world, such as: Houston, Vietnam, Paris, Based on our automatic production line, steady material purchase channel and quick subcontract systems have been built in mainland China to meet customer's wider and higher requirement in recent years. We have been looking forward to cooperating with more clients worldwide for common development and mutual benefit!Your trust and approval are the best reward for our efforts. Keeping honest, innovative and efficient, we sincerely expect that we can be business partners to create our brilliant future!
  • Company director has very rich management experience and strict attitude, sales staff are warm and cheerful, technical staff are professional and responsible,so we have no worry about product,a nice manufacturer.
    5 Stars By Marco from Durban - 2018.09.21 11:44
    We feel easy to cooperate with this company, the supplier is very responsible, thanks.There will be more in-depth cooperation.
    5 Stars By ron gravatt from South Africa - 2017.08.15 12:36

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