Sabre Medical offers accelerated shelf-life testing by exposing packages to elevated temperature conditions in a humidity-controlled environment, to evaluate the effects of storage in an expedited manner.
Why perform Accelerated Aging tests?
It is expected that over time, a sterile barrier system may lose its integrity due to the degradation of packaging materials or bonding agent. The time period before the sterile barrier is likely to fail becomes that product’s shelf life, unless the packaged product itself has a shorter shelf life.
It is necessary to have proof of the sterile barrier’s shelf life; however, as the barrier can often last for a few years, a real-time analysis can become impractical when a product risks obsolescence before the study is completed. Therefore, an accelerated aging test offers an alternative method to simulate the package’s shelf life.
The Arrhenius equation establishes a relationship between the rate constant of a chemical reaction, and the temperature of the environment within which that reaction occurs. Within practical temperature ranges (for example, below extremely high temperatures that would immediately destroy a package), the reaction rate constant increases exponentially with a higher temperature. This logic is extended to the behaviour of the sterile barrier system: exposure to the atmosphere will eventually degrade the seal quality at a set rate, and therefore a raised temperature will accelerate the rate of degradation.
While the specific kinetics of polymer deterioration are complex and often unknown, these are not required to prove a sterile barrier’s shelf life, and an approximation calculation is used to account for the aging process. This formula determines the testing time necessary to represent barrier degradation in an accelerated time period. Use our calculation tool to determine aging conditions for your product.
A range of controlled conditioning chambers are available. The standard chamber runs at a temperature of 55°C, 50% RH. A secondary chamber may also operate at 30°C, 75% RH for real-time tropical aging. Additionally, we maintain a real-time aging room which is controlled at 19-25°C.
We also have policies and validated refrigeration for handling 2-8°C cold chain samples and other temperature-sensitive products. Please contact us to accommodate customised temperatures settings.
Accelerated aging tests are conducted as per ASTM F1980-16, “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”.
These aging studies can be used instead of real-time studies, which should also be laid down at the time of packaging validation. Aging studies should be assessed in the context of a full package validation, as transport simulations at the beginning and end of the shelf life may also need to be demonstrated.