Validating the Sterilization Process for a NEW Medical Device

Overview:

Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

• AAMI TIR # 17 - Sterilization Modalities and Materials Guidance's
• Sterilization validation and Bioburden - D-value
• Shelf Life Test Methods - Accelerated Aging design
• Product design
• The influences of product assembly (molding, automation, etc.)'
• Material selection and post sterilization degradation
• Regulatory Guidance's - AAMI/ISO 11137, AAMI/ISO 11135, etc.
• Packaging Design and Materials

Why you should Attend:

"Do it right the first time", choose the design and material for your medical device instead of going through the post launch cycle of product revisions. Learn the basics for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics.

Learn how to "think like a molecule" and plan and design around sterilization constraints and product/materials qualities (color, odor, brittleness). Learn about:

• FDA's Traditional and Non-Traditional Sterilization Modalities
• Identify the materials that perform best in a given sterilization modality
• Keeping color, odor, and residuals out of your products
• Restraints on Package Designs. Enhance product and packaging designs to take advantage of any given sterilization modality
• Which modality will perform best for my product
• Restraints on Package Design and Maintenance of Package Integrity

Areas Covered in the Session:

• Sterilization Modality Basics and Selection Criteria
• Polymers Chemistry - choosing the best polymer candidate
• Radiation (Gamma, E-beam, X-ray), Ethylene Oxide, Moist Heat, Dry Heat, H2O2, Vaporized Chemical sterilization, Ozone, NO2
• Sterilization Validation - Establishing the baseline cycle/dose
• Accelerated Aging
• Product Validation
• Production Considerations and Assembly Techniques

Who Will Benefit:

• Medical product design Engineers
• Sterilization Experts
• Quality Management and Engineers
• Regulatory Affairs
• Project Managers
• Purchasing and Supply Chain Managers
• Staff evaluating risk, safety, and effectiveness
• R&D Staff - engineering and lab personnel
• Process Engineers
• Packaging Engineers
• Materials Engineers
• Manufacturing Engineers