Presentation: Endotoxin and Pyrogen Testing Using Contract Testing Labs

This presentation describes the responsibilities of a Contract Test Lab (CTL) and their sponsor, including considerations for choosing a CTL when establishing and conducting pyrogen and bacterial endotoxins testing (BET) for pharmaceutical or medical device products.

Topics also covered include:

  • Pharmaceutical and medical products, their raw materials, their regulatory position and testing each for the presence of contaminating pyrogen or endotoxins by the CTL
  • Overcoming testing interferences
  • The special case of Low Endotoxin Recovery (LER)

 

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