Microbiology

Bacterial Endotoxins Testing: USP 85 and 161

Gel-clot, turbidimetric and chromogenic LAL methods, and how to calculate an endotoxin limit for a given product and route of administration.

What this course covers

This course covers the gel-clot, turbidimetric and chromogenic LAL test methods and when each is used, how to calculate an endotoxin limit for a given product and route of administration, USP <85> requirements for bacterial endotoxins testing of pharmaceuticals, and USP <161> requirements specific to medical devices.

Who this course is for

Microbiology and QC laboratory staff performing or reviewing endotoxin testing
QA staff investigating out-of-limit endotoxin results

What you'll learn

The gel-clot, turbidimetric and chromogenic LAL test methods and when each is used
How to calculate an endotoxin limit for a given product and route of administration
USP <85> requirements for bacterial endotoxins testing of pharmaceuticals
USP <161> requirements specific to medical devices
Common endotoxin testing failures and out-of-limit investigation approaches

Why it matters

An incorrectly calculated endotoxin limit, one that doesn't account for the actual maximum human dose and route of administration, can pass products that should fail or unnecessarily fail products that are actually safe. Getting the calculation right is foundational, not a formality.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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