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

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. STERIS Product Testing Services: https://www.steris-ast.com/product-te... STERIS Packaging Testing Services: https://www.steris-ast.com/packaging-... STERIS Testing & Validation Services: https://www.steris-ast.com/testing-va... Find a Location: https://www.steris-ast.com/locations/ Contact Us: https://www.steris-ast.com/contact-us/ Follow STERIS AST: LinkedIn:   / steris-applied-sterilization-technologies   SUBSCRIBE to our channel for more information on contract sterilization, testing & validation, and technical support services at every stage of the sterilization process.