ASTM F1980 Accelerated Aging Calculator

Accelerated Aging is utilized to establish the shelf life of a product relatively quickly. Data obtained from the study is based on conditions that simulate the effects of aging on the materials.

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

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.

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s