Parametric Release for Ethylene Oxide Sterilization | STERIS AST TechTalk
ฝัง
- เผยแพร่เมื่อ 25 ก.ย. 2024
- Qualifying an EO process for routine release by traditional BI? In this TechTalk, you will hear from STERIS AST expert, Niel de Jager, Validation Technical Supervisor EO, about how to validate this process and the data required for routine release. Watch to learn additional aspects that should be considered when validating an EO process for parametric release, and other parameters that need to be monitored and recorded for the routine release of the product based on process parameters.
Parametric Release for Ethylene Oxide Sterilization:
- Run & Record Method
- Validation Method
- Construction of a Validation for Parametric Release
- Parametric Release Specifications
- BI Release to Parametric Release Conversion
Learn more about Ethylene Oxide Processing: www.steris-ast...
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00:00 Introduction
0:37 Meet the Presenter & Overview
1:32 Parametric Release Overview
09:32 Run & Record Method
10:51 Validation Method
11:19 Process Validation Approaches
16:31 Construction of a Validation for Parametric Release
17:51 Parametric Release Specifications
20:01 BI Release to Parametric Release Conversion