Introduction to the Radiation Sterilization Master File Pilot Program | STERIS AST TechTalk

STERIS is the first participant in the FDA’s new Radiation Sterilization Master File Pilot Program, which expedites the approval process for refining sterilization methods of single-use medical devices. This improves supply chain adaptability, mitigating potential roadblocks that might otherwise cause a supply chain shortage or hinder innovation.
In this seminar, learn eligibility requirements, the intricacies of different radiation sterilization modalities, and how STERIS guides Customers throughout the entire process.
Webinar Overview:
PROGRAM INTRODUCTION - Steve Elliott, Senior Manager of Regulatory Affairs
2:09 - Device Master File
3:08 - Master File Pilot Programs
4:21 - Supply Chain Continuity
5:18 - Eligible Changes
6:05 - Benefits of Participation
7:02 - Eligible Medical Devices
8:16 - Non-eligible Medical Devices
10:34 - Customer Product Evaluation Attestation
TECHNOLOGY OVERVIEW - Deepak Patil, Senior Director of Radiation Technology
12:18 - Photons & Electrons
15:32 - Technology Comparison
17:19 - Dose is Dose
18:57 - Modality Transfer
20:38 - Resources (TechTalk - bit.ly/4a6YlRC)
PILOT PROGRAM IMPLEMENTATION - Michael Ezzo, Senior Director of Quality and Regulatory Compliance
21:59 - How Can Customers Coordinate with STERIS?
26:01 - Implementing a Sterilization Process Change
26:48 - Do MAF Validations Differ from Previous Validations?
28:48 - Process Oversight
Q&A
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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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