Categories
Browse records
New Products
  • USP Standard Gel Clot Kit
  • Gel Clot method Multiple Test vial
    Gel Clot Lyophilized Amebocyte Lysate Multi-test Vial

    Gel Clot Method Lyophilized Amebocyte Lysate Multi-test Vial G17 is especially suitable for endotoxin detection in large amounts. Bioendo's Lysate reagent features strong resistance to interference and strong improvement for heat stability.

  • Endotoxin Assay
    Endotoxin Assay Kit for Water and Dialysate (Gel Clot Assay)

    Endotoxin Assay Kit for Water and Dialysate (Gel Clot Assay) assays the endotoxin in water or dialysate by using gel clot technique. Relating operation conforms to USP & EP. Endotoxin-specific Amebocyte Lysate is included by this kit, which will well avoid false positive reaction with Fungi (1,3)-β-D-glucan.

  • GC Endotoxin Test Kit
    Bioendo GC Endotoxin Test Kit (Gel Clot Assay)

    Bioendo GC Endotoxin Test Kit (Gel Clot Assay) includes Amebocyte Lysate, CSE and Water for BET. This will well avoid the mismatching between Amebocyte Lysate and CSE. The Kit is especially suitable for you when you need to do lots of endotoxin detection. Customized gel-clot endotoxin assay kit is also available upon your demand.

  • TAL Endotoxin Testing Assay
    End-point Chromogenic Endotoxin Test Kit (without Diazo Coupling)

    Bioendo EC Endotoxin Test Kit provides a fast measurement for endotoxin quantification. The endotoxin in the sample activates a cascade of enzymes in Amebocyte Lysate, the activated enzyme splits the synthetic substrate, releasing a yellow-colored product with maximum absorbance at 405nm. For End-point Chromogenic Endotoxin Test Kit without Diazo Coupling, a regular spectrophotometer or plate reader is required to read the absorbance at 405nm.

  • Kinetic Turbidimetric Assay
    Bioendo KT Endotoxin Test Kit (Kinetic Turbidimetric Assay)

    Kinetic Turbidimetric Amebocyte Lysate Vial is developed based on the principle that the time needed to reach a certain absorbance increase (onset OD), i.e. onset time, is negatively correlated with the endotoxin concentration. It could be applied to test the endotoxin level of injectable drugs and implantable medical devices.

Endotoxin Challenge Vials (Endotoxin Indicator)

Bioendo's Endotoxin Challenge Vials (Endotoxin Indicator) is produced without excipient, and will not be carbonized under high temperature. Bioendo's Endotoxin Challenge Vials (Endotoxin Indicator) are designed to indicate a minimum 3-log reduction. With table potency, it could be detected with gel-clot, turbidimetric, or chromogenic kit.

  • Item NO.:

    ECV
  • Product Origin:

    China
  • Shipping Port:

    Xiamen/Guangzhou/Shenzhen
  • Lead Time:

    depends on quantity in 2 to 4 weeks
  • Introduction
  • Order information
  • Product qualification
  • FAQ

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 non-baked control Endotoxin Indicators. The Endotoxin Challenge vials are designed to indicate a minimum 3-log reduction in endotoxin content when tested using gel clot, kinetic turbidimetric or chromogenic Lyophilized Amebocyte Lysate assays. Endotoxin Challenge Vial contains 1000-10000EU Endotoxin. ECV1250V and ECV2500V are sealed in vials with heat resistant stoppers and 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 ANSI, AAMI, ISO, USP and the FDA to ensure that all items that are required to be sterile orpyrogen freeare able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious microorganism or pyrogen."

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

Endotoxin potency: ≥1250 or 2500 EU per vial


3. Product Features and Application

In vial with heat resistant stopper, high temperature lid up to 360 Celius, and label. 

when drying operation, no need open rubber lid. 

None excipient. 

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

Catalog number
Endotoxin Level (EU/vial)
Package
ECV1250V
1000 to 10000
In vial, 10vials/Pack
ECV2500V
2000 to 10000
In vial, 10vials/Pack

ECV100000V

50000 to 200000
In vial, 10vials/Pack

How to order Bioendo's Endotoxin Challenge Vails (Endotoxin Indicator)?

Please contact sales@houshiji.com for more product information. 


Endotoxin challenge vial, note lysate reagent and ECV have to match, and no need lid removal during the baking.

Send detail to GET quote now

Esteem Your specified requirements will help us make a complete solution and offer feedback to you quickly. Especially Purchase company Name/Tel/Whatsapp or Wechat for efficient communication.

CONTACT US

Add: 131 Xinjia Road,Haicang Xinyang Industrial zone,Xiamen,China

Contact Person: Haiping Wu
Tel: 86-592-6885886
Fax: 86-592-2095294
Mobile: +8618059871066

Email: sales@houshiji.com 

haipingwu@houshiji.com

Xiamen Bioendo Technology Co., Ltd.

Copyright © Xiamen Bioendo Technology Co., Ltd. All Rights Reserved

 

Chat now

Live Chat

Esteem Your specified requirements will help us make a complete solution and offer feedback to you quickly. Especially Purchase company Name/Tel/Whatsapp or Wechat for efficient communication.

home

products

company

contact