depyrogenation-validation-e-coli-endotoxin

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Depyrogenation Validation Tech Tip

Dry heat sterilization is used to depyrogenate glassware and other non-heat labile materials. The United States Pharmacopeia (USP) states that the endotoxin indicators used in depyrogenation process challenges need to demonstrate at least a 3-log reduction in endotoxin concentration.

Abstract

Although pre-made Endotoxin Challenge Vials are available, there may be instances where preparing your own endotoxin challenge vials are necessary. For this, Endotoxin E. coli O55:B5 (Lonza Catalog No. 00193783) may be used.  This Tech Tip will cover:

  • How to prepare your own endotoxin challenge vials  
  • The testing procedure  
  • How to interpreted your results

 

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