Bacterial endotoxins can have a number of negative biological effects if injected into humans, including fever, septic shock, and possibly even death. It is therefore critical to be able to determine the levels of endotoxins in or on materials that could cause these responses in a patient. Analysts working on BET method development for finished product and/or raw materials need to be able to perform Inhibition/Enhancement testing and determine endotoxin limits by calculating the MVD/MVC.

This on-demand webinar provides information on what an endotoxin limit is and what information is needed to know how to calculate one. An overview of regulations for endotoxin limit calculations, validations, and examples for finished products and raw materials will also be presented. Viewers will also learn about the workflow and thought processes of interference screening and final product validation.

Presenter

  • Jill Schultz, Director, Technical Services & Quality Control, Charles River