Endotoxin Testing Masterclass

What you'll be able to do

• ✓ Explain endotoxin structure and the LAL cascade, including the glucan route
• ✓ Choose between gel-clot, kinetic and recombinant methods
• ✓ Calculate endotoxin limits and the maximum valid dilution
• ✓ Validate gel-clot and photometric methods to USP <85> and Ph. Eur. 2.6.14
• ✓ Solve interference and recognise low endotoxin recovery
• ✓ Validate depyrogenation and investigate endotoxin OOS results

Syllabus

1. MODULE 1Science and methodsEndotoxin, the cascade, methods and limits.

   • Endotoxin and the LAL cascadeFree preview
   • Methods and how to chooseFree preview
   • Endotoxin limits and the MVD
2. MODULE 2ValidationGel-clot, kinetic methods and interference.

   • Gel-clot: validation and routine test
   • Kinetic chromogenic and turbidimetric methods
   • Interference, glucans and low endotoxin recovery
3. MODULE 3Control and investigationsDepyrogenation, water and OOS.

   • Depyrogenation, water and materials
   • OOS results and case studies
   • Final exam (25 questions)

Questions