Bacterial Endotoxin Testing By Gel Clot Method

Learn the principles and practical execution of Bacterial Endotoxin Testing (BET) using the Gel Clot Method in accordance with pharmacopeial requirements and GMP expectations.

This session covers:

1. Endotoxin fundamentals and sources
2. Principle of the Gel Clot Method
3. LAL reagent handling and preparation
4. Positive Product Control (PPC)
5. Method suitability testing
6. Calculation of Maximum Valid Dilution (MVD)
7. Test execution and interpretation
8. Investigation of invalid or failed results
9. Compliance with USP, EP, and JP requirements
10. Documentation and data integrity expectations

Suitable for QC Microbiologists, QA professionals, pharmaceutical manufacturers, and microbiology students.