How to Successfully Validate Sterile Barrier Systems With a Focus on ISO 11607 | STERIS AST TechTalk

Presented by Noel Gibbons, Technical Advisor, Packaging, this TechTalk webinar provides an overview of testing used to support the validation of sterile barrier systems. You will find guidance on the standards typically used during operational qualification (OQ) and process/performance qualification (PQ) after transportation testing and shelf-life studies are performed.

Webinar Overview:
0:11 – Introduction
2:22 – Why Package Integrity and Strength Testing?
3:45 – What Are We Testing?
8:31 – Regulatory Body Expectations
10:33 – Types of Test Methods
13:03 – Packaging Design and Labeling
16:45 – Package Integrity Testing
17:46 – Visual Inspection
29:24 – Dye Penetration Test
31:49 – Bubble Leak Test
35:52 – Burst Test
38:23 – Bubble Leak Under Vacuum Test
40:30 – Extractables & Leachables

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.

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