Bacterial Endotoxin Testing Bacterial Endotoxin Testing (Classroom and Laboratory)

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