TechTalk: Bacterial Endotoxin Testing in Compliance with ISO 11737-3 Testing Standard
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Join Our Mailing ListBacterial endotoxins can pose significant patient safety risks and must be carefully controlled throughout the medical device manufacturing process. In this TechTalk webinar, STERIS AST TechTeam℠ Technical Professionals explain the principles of Bacterial Endotoxin Testing (BET), the role of endotoxins and pyrogens, and the testing requirements outlined in ISO 11737-3.
Whether you work in microbiology, quality assurance, regulatory affairs, or medical device manufacturing, this video will help you understand how BET supports product safety and regulatory compliance.
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In this webinar, you'll learn:
- The fundamental principles of bacterial endotoxin testing.
- Insights into key methodologies and techniques employed during this critical testing process.
- Disparities and commonalities between ISO 11737-3, ANSI/AAMI guidelines, and US Pharmacopeia (USP).
- The unique approaches and requirements outlined in each standard.
- Important considerations when selecting and validating a BET method.
- How endotoxin testing supports regulatory compliance for medical devices.
Webinar Overview:
Introduction
2:26 – Definitions
6:47 – Pyrogens & Bacterial Endotoxins
9:15 – Horseshoe Crab’s Role in BET
Bacterial Endotoxin Testing
11:08 – Principles of DET
20:53 – Method Selection
37:05 – Conclusion
Summary
Bacterial endotoxins are among the most common pyrogenic contaminants found on healthcare products and medical devices. Their presence can trigger serious patient reactions if not adequately controlled, making endotoxin monitoring an essential component of many quality and microbiological control programs.
In this TechTalk webinar, we introduce key microbiological concepts, including the relationship between pyrogens and bacterial endotoxins, before exploring the historical development of endotoxin testing and the role of the horseshoe crab in the widely used LAL testing methodology.
We discuss the principles of bacterial endotoxin testing, regulatory expectations, and practical considerations for method selection. The session also explains how ISO 11737-3 provides guidance for the validation and routine use of endotoxin testing methods to support compliance and patient safety objectives.
Need support with bacterial endotoxin testing or microbiological compliance?
STERIS AST provides comprehensive microbiological testing services to help medical device manufacturers evaluate product safety, meet regulatory expectations, and support compliance with ISO standards.