What is Accelerated Aging?
Accelerated Aging testing is a process of putting packaged products into a chamber, elevating the test temperature to claim a specific expiration date for a medical device product or package. ASTM-F1980 is meant for sterile medical packaging but many companies and or organizations have been using it to claim specific expiration dates for their products.
Accelerated stability studies are used to calculate a product’s expiry date or life period rapidly when there is no real-time data available.
An accelerated ageing testing for medical devices is used to simulate real time shelf-life ageing, in order to validate shelf-life claims. This process is carried out according to guidelines given in ASTM F1980 – Standard Guide for Accelerated Ageing of Sterile Medical Device Packages.
When to use it?
Primarily medical device manufacturers will use accelerated aging testing in their package validation to be in compliance with ISO 11607.
How does it work?
ASTM-F1980 is the document; the theory itself is the Q10 theory. For every 10 degree increase it doubles the reaction rate of the materials. This Q10 factor came from the food industry. This is not an exact science but the FDA allows you to use this theory to get your products to market faster. But you will need to follow it up with real time aging. In doing so, you want to have conclusive evidence that you are not going to have issues with your package or product for that specific shelf life.
How you calculate shelf life of medical device?
For calculation of shelf life of medical device by conducting accelerated aging testing shelf life study.
FACTOR (F):2
[TAA-TRT/10]
Where TAA = Accelerated aging temperature
TRT = Ambient temperature.
Shelf life = Study time period x Factor
Can you use any temperature for AA?
You need to understand where the softening or melting point is before you can pick a test temperature that is going to work properly. Accelerated aging is meant for homogeneous materials while medical devices are comprised of multiple materials can lead to trouble.
Validation studies for ISO 11607 compliance should also cover packaging processes including sterile barrier system forming and sealing.
ASTM F1980 procedure for accelerated aging testing is comprised of the following:
- Select the Q10 value.
- Define the desired shelf life of the package (marketing and product needs, etc.).
- Define aging test time intervals (including time zero).
- Define test conditions, room temperature (TRT), and accelerated aging temperature (TAA).
- Use the Q10, TRT, and TAA to calculate the test duration.
- Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
- Age samples at TAA. In parallel, age samples at real-life aging conditions (TRT).
- Evaluate the package performance after accelerated aging study relative to the initial package requirements.
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