Bacterial Endotoxin Testing; History, Inhibition/Enhancement, and Process Control

The bacterial endotoxin test (BET) is an important part of assuring safety of parenteral pharmaceuticals and medical devices that contact blood or cerebrospinal fluid. Endotoxin (in the form of LPS) is a naturally occurring product of bacterial metabolism, most often shed from gram negative bacteria such as E. coli. The most utilized method for detection and quantification of bacterial endotoxin is the Limulus amebocyte lysate (LAL) test. In this webinar, a brief history of the LAL test and why it is such an important part of quality control will be given. The factors that come into play while selecting a test method, determining sampling size, and performing validation of the test method will be explored.

Viewers will learn:
- A brief history of the LAL test
- Why this testing is important
- Validation testing – Inhibition/Enhancment
- What a testing program looks like
- Common complications