Endotoxin and pyrogen testing using contract testing labs

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This presentation will describe 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. Additionally, this presentation will describe the various pharmaceutical and medical products, their raw materials, their regulatory position and testing each for the presence of contaminating pyrogen or endotoxins by the CTL. Means to overcome testing interferences, and the special case of “Low Endotoxin Recovery” or LER, when testing certain biologics products, also will be covered.

Presenter: Allen Burgenson

Moderator: Saskia Ihle

The presentation lasts 45 minutes and is followed by a live Q&A session.