Fundamentals of Bioburden Testing | STERIS AST TechTalk

STERIS Principal Scientist, Jason Rogers shares an introduction to bioburden method validation and routine bioburden monitoring of single-use medical devices. Bioburden testing is the measure of microbial contamination levels on or in a product. Watch this TechTalk to understand the importance of ensuring your manufacturing process meets microbial quality and sterilization requirements.

Fundamentals of Bioburden Testing Overview:
Key Terminology Defined
Product Bioburden Testing - General Information
Bioburden Test Method Validations
Bioburden Recovery Efficiency Testing
Adverse/Inhibitory Substance Screening
Bioburden Enumeration and Characterization
Bioburden Alert and Action Levels

Learn more about STERIS bioburden testing services:
https://www.steris-ast.com/services/b...

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STERIS Applied Sterilization Technologies provides contract sterilization, laboratory testing and validation, product and packaging testing, and technical support services to manufacturers of medical devices, pharmaceuticals, consumer goods, and industrial products.

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0:00 Introduction
0:40 Meet the Presenter & Overview
1:59 Key Terminology Defined
3:51 Product Bioburden Testing - General Information
17:49 Bioburden Test Method Validation - Recovery Efficiency
21:03 Bioburden Test Method Validation - Inoculated Recovery Efficiency Method
23:38 Bioburden Test Method Validation - Native Repetitive Recovery Efficiency Method
26:28 Bioburden Test Method Validation - Adverse/Inhibitory Substance Screening
31:37 Bioburden Enumeration and Characterization
44:19 Bioburden Alert and Action Levels