Techniques for Medical Device Packaging 2017

Topics

• General Aging Theory - Simplified Protocol
• Shelf Life Test Methods - Accelerated Aging Test Design - Modeling
• Polymers Chemistry - choosing the best polymer candidate
• Accelerated Aging Test Designs
• Regulatory (i.e. FDA) Acceptance and Legal Considerations
• Product Validation and Verification (ISO9001)
• What time periods and what accelerated stresses to target
• Determining Useful Product Life - from Consumer or medical Products to Atomic Reactors
• Reaction Rate Coefficient, Zero and First Order, Q10 = 2; Arrhenius function
• History
• Materials Guidances - AAMI TIR # 17, ASTM
• Enhanced Test Designs i.e. Iterative Test Design
• The influences of product assembly (molding, automation, etc.)`
• Product design - Features to Avoid
• Packaging Design and Materials
• Material selection
• Environmental test Limits
• Quantitative vs Qualitative Test Attributes - Statistical Analysis
• "Ambient" or actual product storage and use conditions
• Worst Case Testing - Achilles Heel
• Commonly used stressors - Temperature, Irradiation, Chemicals, Humidity
• Significance in Differences in Coefficients of Expansion
• Effects of Humidity on common polymers, packaging
• Stress Cycling
• Interim test Intervals
• Effects of sterilization modality (Medical Disposables)
• Results - Conservative, Unrealistic Outcomes
• Test Sample Size Plans and Control Groups
• Critical Temperatures of Plastic Materials - Tg, Tm, Ts

Who should Attend

Attendees from:

• Quality Management and Engineers
• Product Design Engineers
• Project Managers
• Regulatory Affairs
• R&D Staff - engineering and lab personnel
• Staff evaluating risk, safety, and effectiveness