Five Essentials for Starting Accelerated Aging Testing
Understanding how handling, environmental factors, and time affect medical device sterility is critical for ensuring product safety. Real-time shelf-life testing is mandatory under FDA regulations but can take years.
Accelerated aging testing offers a faster alternative by simulating time’s effects using elevated temperatures. Here’s how to plan effectively for accurate, actionable results from accelerated aging tests.
1. Define Real-Time Aging Goals
Accelerated aging testing predicts the long-term performance of products by increasing chemical reaction rates at elevated temperatures. This method helps manufacturers meet launch timelines while awaiting real-time data.
Before starting, decide the real-time aging duration to simulate—six months, a year, or more. This ensures results align with your product’s lifecycle and regulatory needs.
2. Analyze Material Characteristics
Materials age differently under environmental stressors and accelerated aging conditions. Evaluate the chemical composition of your product and packaging to identify potential risks during accelerated aging testing:
● Adhesives, films, or coatings that degrade under heat or humidity.
● Plastic and ink materials prone to leaching.
● Oxidative degradation of unsaturated bonds.
● Polymers sensitive to moisture or high temperatures.
Understanding these traits allows tailored testing, saving time and ensuring reliable results.
3. Select the Optimal Temperature
Choosing the right accelerated aging test temperature is critical. ASTM F1980 recommends 50°C to 60°C but cautions against exceeding 60°C to prevent unrealistic conditions.
● Use tools like WESTPAK’s Accelerated Aging Calculator to balance test duration with material resilience.
A higher temperature shortens the test but may introduce unrealistic stress, while lower temperatures extend the timeline.
4. Account for Humidity Impact
Humidity significantly affects materials prone to moisture-induced changes like swelling, warping, or degradation. If your product is hydrophilic or sensitive to humidity, consult material suppliers to determine its limitations and incorporate this factor into your testing plan.
5. Establish Humidity Parameters
For humidity-sensitive products, maintain controlled conditions—typically 45%-55% Relative Humidity (RH). This ensures your tests mimic real-world scenarios and deliver consistent, meaningful results.
Bonus: Calculate Test Duration
Use the Arrhenius equation, as outlined in ASTM F1980-16, to determine test duration. Key variables include:
● Real-time aging duration.
● Accelerated aging temperature (50°C–60°C).
● Ambient temperature (20°C–25°C).
● Aging factor (Q10, typically 2).
For example, a 40-day test at 55°C simulates one year of aging at 23°C. Raising the temperature by 10°C halves the test time but risks damaging samples.
Avoid Accelerated Aging Test Pitfalls and Ensure Compliance
Thorough preparation and understanding the components of accelerated aging testing ensures your accelerated aging tests meet regulatory and customer expectations, while avoiding common issues like inaccurate simulations or material failures.
Ready to begin testing? Partner with experts like WESTPAK for precise, reliable results that help bring safe, durable products to market faster.