Objectives

• How to identify Low Endotoxin Recovery (LER)
• How to Set-up hold-time studies
• Analysis of influencing factors (Sample matrices, endotoxin, temperature, detection methods, etc.)
• Understanding the driving forces of LER Interpretation of test results
• Dedicated sample treatment for demasking

Background

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 pharmaceutical microbiologists as well as those responsible for the release have to deal with.

And last but not least, how can we handle the test in daily business in a practical manner?

Target Group

• Laboratory management and staff of pharmaceutical microbiology
• Microbiologists and laboratory assistants from contract laboratories
• Scientific staff from the Endotoxin testing area

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