TechTalk: Lab Challenges for Validation of Single-Use Bioprocessing Systems
Choosing optimal single-use bioprocessing devices when developing an enhanced test method is crucial, and doing so requires consideration of intricacies such as size, complexity, variability, aseptic technique, microorganism detection, and lab capacity. After giving an overview of microbiological testing for radiation sterilization validation, Jason Rogers, principal scientist at STERIS Applied Sterilization Technologies, examines each challenge and offers solutions to a variety of constraints. He also encourages experimenters to comply with ISO’s applicable standards for sterilization and explains how to do so.
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Testing & ValidationWebinar Overview:
1:05 Applicable Standards
3:37 Test Method Validation
6:54 Enumeration and Characterization of Bioburden
11:50 Determination/Calculation of Verification Dose
14:03 Test of Sterility
17:09 Best Practices for Devices
18:56 Challenges for Single-Use Systems
