Validating Radiation Sterilization for Medical Products 2017

20 Validating Radiation Sterilization for Medical Products 2017


Course “Validating Radiation Sterilization for Medical Products” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
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
• Test 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
• Biological Polymers – Tissue, Serum
Why should you 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 (Gamma, E-beam, X-ray) 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 Qualification
• Sterilization Validation – Establishing the Minimum Sterilization dose (VDmax)
• Sterilization Modality Selection Criteria
• Biocompatibility
• Preventing Plastic Part Failure Post Irradiation
Who will benefit:
• Medical product design Management and 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
Day 1 Schedule
Lecture 1: The Basics of Sterilization Modality Selection in Product Development AAMI TIR # 17, Irradiation Sterilization – History, Overview
Lecture 2: The Basics of Irradiation Processing – Gamma, E-beam, X-ray, Conversion from other Sterilization Modalities
Lecture 3: Radiation and Polymer Chemistry, Material Selection, Polymer Chemistry
Lecture 4: Packaging Design and Materials, Strengths, Limitations
Day 2 Schedule
Lecture 1: Sterilization Validation – Dose Setting, Bioburden, VD Max,
Lecture 2: Product/Material Qualification Testing – Accelerated Aging
Lecture 3: Irradiation Processing of Radiation Sensitive Materials – Biological Tissues, Serum
Lecture 4: Summary, Alternate Sterilization Modalities, TIR # 17, Putting It All Together

Mr. Karl J. Hemmerich
President, Ageless Processing Technologies
Mr. Karl J. Hemmerich, President of Ageless Processing Technologies, 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, polymer processing, process development and automated assembly, and sterilization process validation. Karl has extensive experience in radiation sterilization with over 10 years in management of a gamma processing facility, as well as a technical resource for Customers with materials and dose related product issues. Karl has made numerous presentations at Customer sales seminars, industry technical conferences and the FDA. Some of the subjects covered included radiation compatibility and selection of materials, gamma processing, dosimetry, package design, validation test design, preventing part failure through enhancements in processing and product design, and accelerated aging.
In 2004 Medical Device and Diagnostics Industry selected Mr. Hemmerich as one of the 100 Most Notable People in the medical device industry. He has written and presented papers on sterilization and materials selection for many corporations, universities and professional organizations, including MDDI, SPE, FDA, HIMA, & ASQC. His paper on radiation effects on polymers published in Medical Device and Diagnostics magazine remains an indus

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