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

[@ramakbalkumar5994]

The bacterial endotoxin test (BET) is an important part of assuring safety of par enteral pharmaceuticals and medical devices that contact blood or cerebrovascular fluid. Endotoxin (in the form of LPS) is a naturally occurring product of bacterial metabolism, most often shed

[@florencefortin3949]

Hello, I just have a question about the MVD calculation. I don't understand how a concentration at 5mg/mL, a specification at 15 EU/mL and a sensitivity at 0.005 EU/mg can equals to 3 000. Is it possible to have an additional variable?

[@Johnn424]

When the specification is expressed in the units of measurement other than EU/ml then the concentration is factor in. In this case, it was not factor in