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.
AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.
Join this Webinar to better understand and start taking advantage of accepted Accelerated Aging Techniques. Understand General Aging Theory — The Simplified Protocol for Accelerated Aging (10 Degree Rule) and Iterative Test Designs.
In order to design a test plan that accurately models the time correlated degradation of polymers, it is necessary to have an in-depth knowledge of materials composition and structure, end product use and mis-use, assembly and sterilization process effects. Basic polymer chemistry will be reviewed as well as the changes in polymer characteristics that can be anticipated and designed for. Learn how to plan for post-production and lifetime functionality.
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.
Learn how to:
Understand the design and use of accelerated aging programs to shorten development time
Identify the materials that perform best in “stressful” environments
Effects of processing (molding, assembly)
Enhance product and packaging designs
Product Design features to avoid
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
Determining Useful Product Life — from Consumer or medical Products to Atomic Reactors
What time periods and what accelerated stresses to target
Reaction Rate Coefficient, Zero and First Order, Q10 = 2; Arrhenius function
Enhanced Test Designs i.e. Iterative Test Design
Materials Guidances — AAMI TIR # 17, ASTM
Product design — Features to Avoid
The influences of product assembly (molding, automation, etc.)’
Packaging Design and Materials
Quantitative vs Qualitative Test Attributes — Statistical Analysis
Environmental test Limits
Worst Case Testing — Achilles Heel
“Ambient” or actual product storage and use conditions
Significance in Differences in Coefficients of Expansion
Commonly used stressors — Temperature, Irradiation, Chemicals, Humidity
Effects of Humidity on common polymers, packaging
Effects of sterilization modality (Medical Disposables)
Interim test Intervals
Test Sample Size Plans and Control Groups
Results — Conservative, Unrealistic Outcomes
Critical Temperatures of Plastic Materials — Tg, Tm, Ts
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 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.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500794LIVE