Accelerated Aging Calculator

In order to sell a medical device or pharmaceutical product in the United States, the FDA requires that the manufacturer prove the sterility and viability of the product on the expiration date prior to selling the product. That means if you market a product "use before June 17, 2019", you must prove that the product is viable on that date before you begin selling it today. To accomplish this, manufacturers employ a derivation of the Arrhenius equation which states (in essence) that molecular activity doubles in organic molecules for every 10° C. rise in  temperature above ambient. Since ambient temperature is (conservatively) considered to be 25° C., storing a product for six months at 35° C. will result in a one-year accelerated aging. Similarly, storing a product at 45° C. for three months will result in an accelerated aging period of one year, and so on. Obviously there is a limit to the upper temperature at which this process is valid and, as a practical matter, most accelerated aging occurs at temperatures at or below 55° C.

To validate this information, most practitioners use a process of real-time aging wherein samples subjected to accelerated aging are compared to those from an equivalent “real-time”. For example, at the beginning of the sales cycle, product can be real-time aged for 3 to 6 months and compared to samples subjected to accelerated aging for the same accelerated period, say 6 months. If the samples of both groups showed similar characteristics, accelerated aging is considered to be validated with real-time aging results. In this manner, a manufacturer can post a lengthy expiration date, begin distributing the product with real-time validation of accelerated aging data, and continue this process through the expiration date of the medical device. It is crucial to maintain careful records throughout this process to avoid recalls and other disastrous potential results.


Accelerated Aging Time (AAT) Calculator

Reference ASTM F1980-07

Desired Real Time (RT): months

Accelerated Aging Temperature (TAA): °C

Notes: Westpak, Inc. does not recommend aging at temperatures exceeding +60°C.
Common aging temperatures are +50°C, +55°C and +60°C.

Ambient Temperature (TRT): °C

Notes: This temperature is typically between +20°C to +25°C.
A temperature of +25°C is a more conservative approach. Aging Factor (Q10):

Note: This factor is typically between 1.8 to 2.5 with a value of 2.0 being the most common value.

Calculated Accelerated Aging Time (AAT): days

Note: The calculated AAT is typically rounded up to the nearest whole day.

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