Event
Course Description:This course provides understanding about Pyrogens, Bacterial Endotoxins and the USP Bacterial Endotxin Test <85> including 1. Calculations according to USP <85> for both the gel-dot and photometric methods and 2. Hands-on Bacterial Endotoxin Test by the Gel Clot Technique: Determination of the Maximum Dilution (MVD) confirmation of LAL reagent sensitivity using USP Bacterial Endotoxins RS and use of the interfering Factors Test for Gel-Clot Method.
Objectives:
- The role of USP in microbiology and sterility assurance
- Pyrogens and Bacterial Endotoxins
- Bacterial Endotoxin Test Methods - Theory and Practice
- Calculation of Endotoxin Limits
- Participation in the USP standards-setting process
Who should participate:
- Quality assurance/quality compliance staff
- R.A. managers
- Scientists
- Investigators
- Other professionals who work or interact in a pharmaceutical microbiology laboratory environment