Techniques for Medical Device Packaging 2017 is a webinar that covers topics such as:
- 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
Techniques for Medical Device Packaging 2017 is intended for 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