Accelerated Aging Calculator
NOTES
- The calculated AAT is typically rounded up to the nearest whole day.
- Protech does not recommend aging packaging materials at temperatures exceeding +60°C. Common TAAs are +50°C, +55°C, and +60°C.
- Ambient tempreature is typically between +20°C to +25°C. A temperature of +25°C is a more conservative approach.
- The aging factor is typically between 1.8 – 2.5 with a value of 2.0 being the most common value.
More About Accelerated Aging in Medical Device Packaging and Our Calculator
At PRO-TECH Design, we understand the importance of validating your medical device’s shelf life through reliable accelerated shelf-life testing. Our Accelerated Aging Calculator provides a precise way to determine how your medical products will perform over time under various environmental conditions. The calculator helps estimate a product’s aging process and supports medical device manufacturers in meeting industry standards for shelf-life testing and product expiration dates.
The process itself incorporates engineering support services and follows strict regulatory standards, ensuring that your medical device packaging design maintains its integrity throughout its lifespan.
Key Features of the Accelerated Aging Calculator:
With expertise in medical device stability testing and understanding the relationship between temperature and time, we provide comprehensive solutions for medical packaging components and medical device contract manufacturers.
- Input the desired real-time aging or target shelf life.
- Set ambient temperature and accelerated aging temperature.
- Customize values for Q10 to reflect typical rates of chemical reactions.
- Results rounded for ease of use, ensuring alignment with regulatory standards.
- Guidance from an experienced packaging engineer for more tailored packaging solutions.
Benefits of Using the Accelerated Aging Calculator:
- Test your packaging under accelerated conditions to bring your product to market faster.
- Ensure sterile barrier systems maintain sterile integrity throughout the shelf life.
- Validate packaging performance at elevated temperatures for a shorter period of time.
- Minimize risk by adopting a conservative approach with controlled temperature and ambient storage temperature settings.
How It Works
By increasing the ageing temperature to simulate accelerated conditions, the accelerated aging process is used to predict the long-term performance of packaging materials and medical devices over a shorter period of time. The calculator takes into account the principle that an increase in temperature doubles the reaction rate, allowing you to calculate product durability without the need for full real-time study durations. Our comprehensive process also includes stability studies for drug products and medical product packaging.
Frequently Asked Questions
What is the Accelerated Aging Calculator?
The Accelerated Aging Calculator is a tool used by medical device manufacturers to estimate how medical devices and packaging materials will degrade over time under elevated temperatures, enabling faster product-to-market introductions.
What is the relationship between temperature and aging?
As temperatures rise, the reaction rate of chemical reactions doubles for every 10°C increase, which shortens the aging process in real-time aging tests.
What temperatures should I use for accelerated aging?
Typical values for accelerated aging temperature are between +50°C to +60°C, with the most common ambient temperature being +25°C. Using conservative values ensures accurate shelf-life testing results.
How does ambient humidity affect the results?
Controlled humidity is a factor during testing. Excessive humidity may accelerate the deterioration of materials, and we recommend monitoring humidity levels alongside temperature.
How long does the accelerated aging process take?
The testing duration depends on the shelf-life testing requirements and the desired real-time aging period. Typically, shorter periods of time at higher temperatures are used to simulate longer periods at normal conditions.
Can the calculator be used for various medical product types?
Yes, the Accelerated Aging Calculator supports testing for a wide range of medical products, from drug products to complex medical device packaging.
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