Accelerated Aging Testing
An Accelerated Aging Test is performed on products to rapidly determine the effects of time by subjecting samples to elevated temperatures.
Accelerated Aging Testing
Accelerated Aging, also known as accelerated shelf-life testing, is a standard practice in several different industries. The test determines the effects of time, if any, by subjecting samples to elevated temperatures. Westpak has conducted Accelerated Aging on medical devices, food, and consumer packaged goods, to name a few product types.
The Accelerated Aging process is based on the relationship between temperature and chemical reaction rate, in which the reaction rate increases as temperature rises. The Accelerated Aging test uses higher temperatures to accelerate the aging process by representing Real-Time Aging artificially. Manufacturers can utilize an Accelerated Aging’s results as justification to get their product to market faster and establish necessary safety and efficiency assurance. Real-Time and Accelerated Aging studies must be performed in parallel to completion and the claimed shelf life of the product.
Westpak’s accredited lab facilities offer Accelerated Aging testing per ASTM F1980. With over 35 years of integrity in testing, our sales team can help you determine the best test types and aging variables for your product’s success.
What is the purpose of Accelerated Aging tests?
Accelerated Aging tests offer valuable insight into the effects of time and environmental conditions on a product and its packaging. With this information, manufacturers can:
- Accurately identify shelf life
- Establish expiration dates
- Comply with regulatory standards
- Set parameters for safe transportation and storage
- Get products to market faster and with less risk
- Boost consumer confidence
How do Accelerated Aging tests work?
Accelerated Aging tests expose products to elevated temperature conditions under shortened timeframes to study their reaction to the aging process in transportation, in-use, and storage environments. During these tests, laboratories apply the Arrhenius equation to study a product’s chemical response to mainly temperature, and sometimes relative humidity.
According to the Arrhenius equation, a sterile barrier system (SBS) subjected to 40 days of Accelerated Aging at +55°C has aging properties that are estimated to be equivalent to a 1-year-old Real Time sample with the assumption of an ambient storage temperature of +23°C. When the temperature is increased by 10°C, the duration to simulate one year is decreased from 40 to 20 days. However, elevated temperatures may cause unintended damage to materials when the glass transition temperature is reached. A conservative approach to Accelerated Aging is usually advised.
Regulatory authorities acknowledge Accelerated Aging data as an appropriate way to gather data quickly, but only when those tests are correlated to Real-Time samples is this data approved. Real Time Aging is conducted by placing the packaging materials at ambient temperature, in a secure location, for the natural length of time intended. Westpak can perform Real-Time Aging at specific time points, which should correlate to Accelerated Aging test data.
What is the Arrhenius equation?
The Arrhenius equation is an expression that shows how the rate constant of a chemical reaction, absolute temperature, and the aging factor are related. The Arrhenius equation indicates that a +10°C increase in temperature doubles the rate (known as an Q10 factor of 2) of chemical reaction. This is the most popular and conservative method of calculating Accelerated Aging. It's used to test shelf-life claims and document expiration dates by simulating real-world shelf-life aging.
Frequently Asked Questions
Get answers to our most frequently asked questions.
What are the Accelerated Aging test standards performed at Westpak?
Westpak performs Accelerated Aging tests using the following standards:
ASTM F1980-21 was released in December 2021. Were the changes significant?
The new revision recommends that the use of controlled humidity during Accelerated Aging be considered, findings documented, and used if warranted. The need for humidity usage should be based on the characterization of materials used in the device and packaging, and the long-term storage use condition.
Where can I learn more about the new F1980-21 version changes?
We’ve studied the new version and provided findings and recommendations on our ASTM F1980 webpage.
What are the typical variables used in the Accelerated Aging test method?
- Testing temperature: Typically between +50°C and +60°C, most commonly +55°C.
- Ambient storage temperature: Generally between +20°C and +25°C. +20°C will generate the shortest test duration due to the largest temperature delta
- Conservative Q10: Typically 2 for medical devices.
- Relative Humidity: RH is not a factor in the Arrhenius equation. Relative humidity is typically recorded, but not controlled.
- Testing duration: Expiry dates for medical products are typically based on manufacturing date. Some manufacturers add an extra month to the aging study to allow for sterilization and distribution. For example, a 12-month shelf life is simulated based on a 13-month study.
What is the duration of an Accelerated Aging test?
The Arrhenius reaction rate function is used to calculate the duration of testing time. The length of the test is entirely up to the manufacturer, but there are plenty of industry-accepted guidelines to follow. Please note that the more aggressive the temperature, the faster the test. However, temperatures above +60°C are not recommended due to the increased likelihood that several polymeric systems will experience non-linear changes, such as percent crystallinity, formation of free radicals, and peroxide degradation. Our team of experts may use their knowledge and experience, as well as industry standards, to recommend the testing duration that is most appropriate for your product.
How does Accelerated Aging testing help determine the shelf-life of a product?
By simulating aging in a controlled environment, Accelerated Aging tests offer a detailed view of what a product’s shelf life may look like. By applying elevated temperatures with an option of relative humidity, lab researchers can use the Arrhenius equation to inform manufacturing decisions, storage parameters, and more.
How is a test sample evaluated after an Accelerated Aging test?
After an Accelerated Aging test, the physical qualities and sterile integrity of a testing sample will be compared to those that have not been exposed to the simulated environment (referred to as Zero-Time). The test samples selected for evaluation should focus on materials affected by aging or package functionality. Westpak will produce a full report detailing the aging conditions and testing standards employed and documentation of the equipment utilized after Accelerated Aging testing is complete. Finally, we'll go through the results of the post-aging testing, as well as any statistical approaches used to determine whether the sterile barrier system (SBS) meets the product's performance requirements.
What is the relationship between Accelerated Aging and Real Time Aging?
Accelerated Aging simulates the effects of time quickly by subjecting test samples to elevated temperatures using environmental test chambers. In contrast, Real-Time Aging samples are stored in a secure location and remain undisturbed in ambient environmental conditions for the required duration, typically one, two, or three years. After the Real-Time exposure, samples are withdrawn, studied, and compared with Accelerated Aging samples and data. Ideally, there should be little to no difference between the two sample sets. However, differences must be throughly investigated and appropriately actioned.
Testing at Westpak has been accredited by A2LA to comply with ISO 17025.
Westpak testing labs are ISTA certified to perform a variety of tests.