Verification Dose: Complying with ISO 11137 | STERIS AST TechTalk

Learn the steps required to establish a validated dose range for E-beam, gamma, or X-ray irradiation processing in compliance with ISO 11137. In this TechTalk Senior Radiation Sterilization Manager, Betty Howard defines standard terms, processes, and how to determine maximum and minimum dose settings.
Learn the Role of Verification Dose when complying with ISO 11137:
- What Standards Are Used?
- What is Sterility?
- What is a Dose Range?
- Maximum Dose
- Minimum Dose: Dose Setting Methods & Microbiological Methods
- Process Flow VDMax
- Process Flow Method 1
- Maintaining a Validated Dose Claim
Learn more about STERIS AST’s Radiation Sterilization Validation Services:
www.steris-ast.com/services/r...
__________________________________________
About Us:
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.
Visit Our Website: www.steris-ast.com/
Find a Location: www.steris-ast.com/locations/
Contact Us: www.steris-ast.com/contact-us/
Follow STERIS AST:
LinkedIn: / steris-applied-sterili...
Facebook: / sterisappliedsteriliza...
Twitter: / steris_ast
SUBSCRIBE to our channel for more information on contract sterilization, testing & validation, and technical support services at every stage of the sterilization process.
0:00 Introduction
00:41 Meet the Presenter & Overview
2:30 What Standards Are Used?
3:37 What is a Sterilization Dose Range?
7:16 Dose Setting Methods
9:03 Which Method and Why?
12:47 Bioburden Method Suitability
14:40 Sterility Method Suitability
16:19 VDMax Methods
22:47 Process Flow
25:11 Maintenance of Validation: Dose Audits
26:41 Dose Audit: Interpretation of Results