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Radiation Sterilization of Medical Products - Beyond the Basics

May 24, 2021

ComplianceOnline, Virtual Training Through WebEx 2021-08-12 DAY 01(9:00 AM - 5:00 PM EDT) Session Start Time: 9:00 AM Review of the radiation sterilization – modalities, history, strengths and limitations, terms, processing parameters. History/Terms Gamma, E-beam, X-ray – Is there a best choice? Irradiator Designs and Processing Variables Dose Rate and Distribution Costs - Contractors, In-house Systems Process Validation – Part I History – Kilmer and Beyond VD Max Method 1 Method 2 Dose Audits Materials Selection - Radiation Effects Polymer Chemistry AAMI - TIR # 17 Guidance Offered Desirable/Undesirable Changes Brittleness Color Change Odor Hardness/Softness Films, Adhesives Crosslinking/Toughness Stress – Out of Our Parts, Out of Our Lives Supplier Databases and Websites Process Validation – Part II Bioburden Sampling Sterility Testing Family Grouping Dose Audits Product and Process Design – It all starts in R&D Critical Decision Points The Shotgun vs a Targeted Approach Molding/Extrusion 3D Printing Bioburden Control and Epidemiology Environmental Control Control Levels Bioburden Excursions Typical Causes and How to Fix Them People and Processes Laboratory Issues Choose a Good Partner and Save Time Bioburden Counts – What does it Mean Recovery Efficency IDs – Where did that come from? Sterility Failures Typical Causes and How to Address Them Planning Timeline Basic Biocompatibility DAY 02(9:00 AM - 5:00 PM EDT) Packaging – Design & Materials Regulatory Requirements Design Latitude – Pouches, Trays, Materials Materials to be Avoided Breathability Requirements ISO/AAMI/FDA Standards ISO 11137-1 ISO 11137-2 ISO 11137-3 TIR # FDA Guidance Unique Materials Polypropylene and Polyethylene PC, Polyester Product Validation Dose Limits Attributes – Design Limits Accelerated Aging Unique Aspects of Different Product Types Biologics and Tissue Sterilization Validation and Processing Pharmaceuticals Combination Products Sterilization Product Validation Summary/Planning… Planning…Planning Learning from 483’s - Case Study Exercise from current FDA Warning Letters The SAL Debate 10-6, 10-3, 10-4 North America, Europe, ……

Organized by:			ComplianceOnline
Invited Speakers:			Martin Byrne has over 25 years of experience in the areas of radiation, ethylene oxide, and radiation sterilization including both gamma and ebeam sterilization. He has provided sterilization support for both large, mature medical device manufacturers as well as small startup companies. Currently, he owns Sterilization Illustrated a consulting and training business that provides support in the area of sterilization, microbiology, and controlled environments. An introductory video can be found at his website, www.sterilizationillustrated.weebly.com that will provide further information about Martin.

Deadline for Abstracts:			2021-08-11

Registration:			1,899^* (Seminar for One Registration) August 12-13, 2021, Virtual Seminar Register now and save $200 (Actual Price: $2,099)
E-mail:			referral@complianceonline.com

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