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Validating Radiation Sterilization for Medical Products
Karl J Hemmerich
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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:
- Materials Guidances - AAMI TIR # 17, ASTM
- Sterilization validation and Bioburden
- Shelf Life Test Methods - Accelerated Aging design
- Product design
- The influences of product assembly (molding, automation, etc.)’
- Material selection and post irradiation degradation
- Regulatory Guidances - AAMI/ISO 11137, TIR #17
- Packaging Design and Materials
Why you should Attend:
"Do it right the first time", choose the most functional and radiation resistant materials for your medical device instead of going through the post launch cycle of product revisions. Also learn the basis 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 radiation induced changes in materials qualities (color, odor, brittleness). How to avoid the materials that are "APT" to fail.
Learn how to:
- Identify the materials that perform best upon radiation
- Keep color and odor out of your irradiated products
- Enhance product and packaging designs to take advantage of radiation
- Which modality will perform best for my product
Areas Covered in the Session:
- Polymers Chemistry - choosing the best polymer candidate
- Gamma, E-beam, X-ray sterilization
- Accelerated Aging
- Product Validation
- Sterilization Validation - Establishing the baseline dose
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
Speaker Profile
Karl J Hemmerich has over 35 years of experience in medical device product design, development, manufacturing, and sterilization. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and sterilization process validation.
He is a member of the Editorial Advisory Board for MDDI magazine as well as a contributing member of the AAMI "Radiation Materials Working Group" that developed Technical Information Report # 17 as the guidance for materials selection, qualification/validation test techniques and quality processing methods for all common sterilization methods. He has written and presented papers on sterilization and materials selection for many corporations, universities and professional organizations, and his papers on Radiation Effects on Polymers and General Aging Theory published in Medical Device and Diagnostics magazine remain industry standards.