ASTM F1980: Standard for Accelerated Ageing of Sterile Barrier Systems and Medical Devices

In accelerated ageing tests for medical devices, a material or Sterile Barrier System (SBS) is exposed to elevated temperatures for a condensed amount of time. By exposing the testing materials to more extreme conditions during a shorter time frame, researchers can evaluate how a product will age under normal conditions without waiting for the entire desired duration. Armed with this knowledge, manufacturers can determine shelf life, storage, in-use, and transportation parameters more accurately for their product.

Accelerated ageing is a standard practice in the medical device industry for determining shelf life parameters by accelerating the effects of time on a Sterile Barrier System (SBS).

The accelerated ageing process is based on the relationship between temperature and reaction rate, in which the reaction rate increases as the temperature rises. The Arrhenius Equation is the basic formula used for an accelerated ageing test for medical devices is:
Accelerated Ageing Time (AAT) = Desired Real Time (RT) divided by the Accelerated Ageing Factor (AAF).

lO summary
Every 10 C increase in ageing temperature shortens the AAT by half.
Therefore, if you have a product whose expected shelf life is 3 years or 36 months, the device is expected to 'age' or experience :
> For ambient storage 25°C.; keeping the product in a chamber at 35°C., the product is expected to 'age' in 18 months.
> For ambient storage 25°C.; keeping the product in a chamber at 45°C., the product is expected to 'age' in 9 months.
> For ambient storage 25°C.; keeping the product in a chamber at 55°C., the product is expected to 'age' in 4.5 months.

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

QRA does not recommend ageing packaging materials at temperatures exceeding +65°C. Common Accelerated Ageing temperatures (TAA) are +50°C, +55°C, and +60°C.

The ambient temperature (TRT) is typically between +20 °C to +30 °C. A temperature of +25°C is a more conservative approach.

The ageing factor is typically between 1.8 to 2.5 with a value of 2.0 being the most commonly accepted value.

To perform ASTM F1980 accelerated ageing tests for medical devices, the laboratory facility must identify the Q10 value of the testing sample. The Q10 temperature coefficient is a measure of how quickly a material system changes when the temperature is increased by +10°C.

ASTM International sets forth specific test parameters to ensure consistent testing across different lab facilities. The basic parameters for ASTM F1980 include the following:
1. Accelerated Ageing Temperatures
2. Humidity (F1980 - 21)
3. The quantity of product testing samples

Confidence Level I Reliability Level 95% Confidence I 95% Reliability 95% Confidence / 90% Reliability

After the Accelerated Ageing Tests, it is advisable to send your medical products to
a) Peel Test
b) Bubble (full immersion) Test
to determine the Confidence and Reliability Levels. QRA can advise you on these matters.

Using the Arrhenius Equation, the TRT should accurately reflect the actual product storage and in-use conditions, generally between 20 °C and 30 °C.

Accelerated ageing temperature should be identified before testing. This is done by having in-depth knowledge of your materials, product, and packaging. It is not recommended to exceed +65 °C.

The need for controlled humidity during accelerated ageing should be identified before testing; if materials are subject to moisture degradation, 45% - 55% RH is suggested. This input should be determined with your material providers' assistance.
A Q10 factor needs to be determined, which involves testing materials at various temperatures and defining the differences in reaction rate for a 10° change in temperature. A typical Q10 factor used during testing is 2.

Accelerated ageing factor should be specified using the following equation:
AAF = Q10 (TAA-TRT)/10
QRA's sales professionals can walk you through your product ageing test needs.

The ASTM F1980 standard suggests using an accelerated ageing temperature below 60 °C. Ageing your product at a greater temperature provides the advantage of a faster simulation of the ageing interval, but this comes with risks for particular products and packaging materials.

Medical devices are often engineered with delicate materials that may drastically change when exposed to temperatures exceeding +60 °C. Finding out if your medical product or device may be adversely affected by long periods of high heat or low humidity is a good place to start when choosing the best accelerated ageing temperature. Westpak's experts can help you define the ideal temperature parameters for your products and packaging.

Common Accelerated Ageing Temperatures: 50°C, 55°C, 57°C or 60°C

In short, humidity is not a required element of accelerated ageing. The recent version suggests that humidity conditions in the ageing study be defined before starting ageing studies. If RH will not be controlled, the rationale for exclusion should be documented.

Humidity usage is dependent on the materials used in your product and packaging, how moisture impacts them, and other environmental factors. If humidity during accelerated ageing is to be controlled, Westpak recommends conferring with our sales team to determine the RH level to be specified in the test plan. Also, as per F1980-21, the rationale for uncontrolled humidity should be documented.

After a testing sample has undergone the accelerated ageing process, its physical properties and package integrity will be compared against various ageing time points.
This includes visual inspections per ASTM F1886, sterile integrity testing
> Burst
> Bubble
> Dye
> Peel testing.
You will want to test at all-time points noted on your packaging shelf-life label. When this process is complete, QRA through its partner company will deliver a comprehensive report specifying the ageing conditions and testing standards applied, as well as documenting the equipment used. Finally, we'll detail the outcomes of the post-aging tests, and any statistical methodologies utilized.

Whether you have a released medical device or a new product in development, QRA sales experts can help. Our recommendations will be based on your company's unique product, market, and any special requirements.