Expert Support At Your Fingertips for the Bacterial Endotoxins Test

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QC Insider - Endotoxin Expertise at Your Fingertips™


PyroGene™ White Paper: It’s Time to Embrace the Alternative


The supply of lysate for bacterial endotoxin testing (BET) is dependent on three horseshoe crab species: Limulus polyphemus found in North America, as well as Tachypleus gigas and Tachypleus tridentatus, which live in various regions in Asia.


There are several reasons why the industry has reached a critical point where we can no longer rely on a potentially finite natural resource, and where a sustainable and alternative means of endotoxin detection is necessary.   


Our White Paper topics include: 


  • The growing demand of a natural resource
  • Benefits of the synthetic version of Factor C
  • How to validate the PyroGene™ rFC Assay: it’s easier than you think    


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After clicking on PyroGene™ White Paper:  It's Time to Embrace the Alternative, input your user name and password on the login page. You will then be directed to the White Papers page where you can access the latest tool.   Register and you will be directed to a Registration Page. After you have successfully registered, you will be able to navigate through the QC Insider™ Toolbox and access the new White Paper.


Delivered to you from the QC experts who face many of the same regulated manufacturing challenges as you do, the QC Insider™ Toolbox is packed with comprehensive support tools that will help you perform the bacterial endotoxins test.


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Explore Our Resources


QC Insider™ Support: direct access to one-on-one guidance and detailed information about software support, recertification & testing services, reader install & maintenance and workflow optimization.


QC Insider™ Training: self-directed training resources that will help you build on your bacterial endotoxins test expertise.


QC Insider™ Library: technical resources that will help ensure your success with the bacterial endotoxins test. You will have access to a collection of package inserts, quick guides, technical tips and more.


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Data Integrity Webinar Archive


Our Archived Webinar presents the principles of data integrity and how QC professionals can show “proof” of data integrity in their process.  


Topics include:            
  • Criteria for data integrity and recent guidance issued from the FDA                
  • Kinetic vs. subjective test methods
  • How WinKQCL™ Software helps satisfy the 21 CFR Part 11 compliance requirement                                                                                                                                                            

Login or register to access the White Paper.