Aging and Expiry Dating

ISO 11607 guidance calls for documentation that the packaging remains functional until the claimed expiry date.

Real-time aging must be done followed by package integrity testing to show that the contents of the package remained sterile. Accelerated aging and package integrity testing is allowed so the product release date can be brought forward, provided that real-time aging is underway and was started at the same time.

We are set up to perform real-time and accelerated aging (at 40 degrees C and 55 degrees C) Aging, both real-time and accelerated, is the method by which support for expiry dates of medical device packages is determined. For real time aging, physical properties of post-sterile sample packages are tested at Time = 0, then they are tested again at various periods usually up to three or five years, depending on the preferred expiry date, having been stored at ambient conditions (normally 20-25°C).
Typical strength tests may include tensile properties, flex crack resistance, tear strength and puncture resistance, while typical package testing may include microbial barrier, seal strength and package integrity. Accelerated aging is desirable as it can reduce time to market. Aging is accelerated by storing the samples at an elevated temperature (TAA ), as the higher the temperature the greater the accelerated aging factor. The theory is based on the Arrhenius equation, which simply stated, says that chemical reaction rates are increased by a factor of 2 for every 10 degrees C increase in temperature.