Accelerated Aging Calculator - Accelerated Aging Test Services
Rocky Mountain Testing Solutions has multiple environmental temperature chambers maintaining different set points that can be utilized for all of your accelerated aging needs. We will make sure that you satisfy the internal and industry standards of your project. Accurate and reliable accelerated aging results will be provided based on your requirements along with exceptional, personal service. When testing is completed, you will receive a detailed, clear report for your product qualification and third-party validation testing. If you are ready to test now or if you need assistance in developing a test specification, call RMTS.
- Test Temperature (°C)
- Q10 (Reaction Rate Factor)
- Ambient Temperature (°C)
- Real-Time Equivalent (Day/Week)
Accelerated Aging in Detail
The common and conservative means of the accelerated aging calculation is based on the Arrhenius equation which states that a 10°C increase in temperature doubles the rate of chemical reaction. It is used to simulate real shelf-life aging and is conducted to validate shelf-life claims and document expiration dates. These accelerated tests help pinpoint possible seal and burst strength faults, leaks, and film delamination in medical device and pharmaceutical packaging. The tests are prominent in biomedical research, pharmaceutical, and medical device packaging and are a FDA requirement.
Accelerated aging is testing that uses conditions of heat, humidity, oxygen, sunlight, vibration, 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. It is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. This occurs with products that have not existed long enough to have gone through their useful lifespan. For example, a new type of car engine or a new polymer for replacement joints.
Physical testing or chemical testing is carried out by subjecting the product to different levels of stress for long time periods, unusually high levels of stress used to accelerate the effects of natural aging, or levels of stress that intentionally force failures (for further analysis).
Parts are run at very high speed, far in excess of what they would receive in normal usage. Polymers are often kept at elevated temperatures, in order to accelerate chemical breakdown. Also, the device or material under test can be exposed to rapid (but controlled) changes in temperature, humidity, pressure, strain, etc. For example, cycles of heat and cold can simulate the effect of day and night for a few hours or minutes.
The Arrhenius Equation - The Formula for the Calculation
The Arrhenius equation is a formula for the temperature dependence of reaction rates based on the work of Jacobus Henricus Van't Hoff in the late 19th century. Van't Hoff's equation for the temperature dependence of equilibrium constants suggests such a formula for the rates of both forward and reverse reactions. Arrhenius provided a physical justification and interpretation for the formula.
Currently, it is best seen as an empirical relationship. It can be used to model the temperature variation of diffusion coefficients, population of crystal vacancies, creep rates, and many other thermally-induced processes/reactions.
A historically useful overview supported by Arrhenius' equation is that, for many common chemical reactions at room temperature, the reaction rate doubles for every 10° Celsius increase in temperature.
The Arrhenius equation is explained in detail courtesy of the Khan Academy.
Arrhenius equation: Definition of rate constant k, the pre-exponential factor A, and activation energy. How the exponential part of the Arrhenius equation depends on activation energy and temperature.
Standards for Accelerated Aging
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:
Most Common Variables For Accelerated Aging
- Accelerated Test Temperature are typically between 50 to 60C, most common 55°C.
- Ambient storage temperature is typically between 22°C to 25°C. 22°C will results in the shortest test duration.
- Conservative / common Q10 is 2 for medical devices.
- Relative Humidity (RH) is not a factor in the Arrhenius equation. However, RH should be kept under 30% so material is not damaged.
- The expiry date of a medical product is commonly based on its manufacture date. Therefore, some add an extra month to the aging study to allow for sterilization, etc. For example, a 12 month shelf life is simulated based on 13 months.
The calculator below generates a table of values for calculations based upon ASTM F1980, Accelerated Aging of Sterile Medical Device Packages.