TechTalk: Practical Navigation of the Approaches Contained in ISO 11137-2 and ISO 13004
In this webinar, STERIS Senior Scientist David Ballard and Laboratory Technical Manager Sarah Conway outline how a product’s specific requirements, such as bioburden levels and dosage requirements, can be used to determine the most effective radiation sterilization approach in accordance with ISO standards.
40.42
Testing & Validation
Webinar Overview:
2:30 – Definitions
4:20 – Microbiological Radiation Validation Phases
6:34 – Laboratory Testing Standards
7:00 – Sterilization Dose / Max Dose
8:09 – The Radiation Standards – Approach Options
20:06 – Radiation Validation Approach Selection
37:30 – Key Takeaways