Accelerated Aging Techniques for Medical Device Packaging
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Why should you Attend:
Accurate prediction of product shelf-life performance is critical to your success. “Do it right the first time”, choose the most functional and resistant materials for your product instead of going through the post launch cycle of panic driven product revisions. Also learn the basis for choosing the optimum accelerated test design based on materials, product design, processing, and functional product requirements. Learn how to “think like a molecule” and plan and design around “aging” induced changes in materials qualities (brittleness, color, and odor) that cut short your product’s long term functionality. The understanding of a product’s long term safety and efficacy is a must in today’s litigious world.
Areas Covered in the Session:
Shelf Life Test Methods — Accelerated Aging Test Design — Modeling
General Aging Theory — Simplified Protocol
Accelerated Aging Test Designs
Polymers Chemistry — choosing the best polymer candidate
Product Validation and Verification (ISO9001)
Regulatory (i.e. FDA) Acceptance and Legal Considerations
Who Will Benefit:
Product Design Engineers
Quality Management and Engineers
Staff evaluating risk, safety, and effectiveness
R&D Staff — engineering and lab personnel
Liability — Lawyers, Paralegals
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.