Medical Device Accelerated Aging Calculator

Sam Lazzara
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There are calculators for figuring out how fast you can pay off your mortgage, so why not have a calculator to figure out how fast you can age your medical devices?

ASTM F1980 is the standard most people refer to for medical device accelerated aging.
Its title is Accelerated Aging of Sterile Medical Devices.

I am sharing my Excel Accelerated Aging Calculators workbook. It is not formally validated but I am pretty sure it is accurate. Please let me know if you find any mistakes or have improvement suggestions.

CAUTION - There are three different tabs in the Excel workbook based on different assumptions for the ambient temperature. I have tabs for 20, 22 and 23 deg C. The standard mentions using 25 deg C as a conservative number but it does not "require" this temperature to be assumed. If you are feeling frisky, do what I do lately and use/justify 20 deg C as your assumed ambient temperature. And keep your warehouse cool....

Also, below is an excerpt from my accelerated aging Standard Test Method.


Accelerated Aging Methodology
The accelerated aging methods described in this protocol are based on ASTM F1980 and the assumption that for every 10oC (18oF) above ambient temperature, the aging rate is doubled. Ambient temperature is assumed to be 20oC. The ‘Simulated Days’ is calculated as shown below:

Accelerated Aging Factor = AAF = 2(T-20)/10, where T is the ‘Chamber Temperature’ in oC

Accelerated Aging Time = AAT

Simulated Real Time Aging = SRTA = AAF x AAT

AAT = SRTA / AAF

Example

For T = 60oC, AAF = 2(60-20)/10 = 24 = 16

Therefore, each day at 60oC equals 16 days of real time aging

For SRTA = 365 days, AAT = 365 / 16 = 22.8 days (23 days when rounded up to nearest day)

NOTE: If post-accelerated aging test results meet acceptance criteria, the shelf life is conditionally validated pending the results of real-time aging results.
Sam Lazzara
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+1 510 397 9739
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