In the last years the LAL test has become the preferred system to test for endotoxins – for the in process control as well as in the final inspection – and it is anchored in the pharmacopoeias. However, in the recent past, the problem of low endotoxin recovery employs the pharmaceutical microbiology. Masking – or not? Evidence gaps? And how can I close them? And how to evaluate?
These are the questions the pharmaceutical microbiologists as well as those responsible for the release have to deal with.
In this webinar you will get an insight into the current situation:
a. Functionality of the LAL Test
b. Test Control 'PPC'
c. Monitoring “Low Endotoxin Recovery”
b. Driving Forces (examples)
3) Solution approaches and perspectives
Laboratory management and staff of pharmaceutical microbiology
Microbiologists and laboratory assistants from contract laboratories
Authority representatives involved in the topic
Scientific staff from the area pyrogen testing
QA staff who has to evaluate endotoxin results and deviations
Johannes Reich, University Regensburg, Germany