Stability Studies for Medical Devices
An accelerated ageing test for medical devices is used to simulate real time shelf-life ageing. It is conducted 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.
During an accelerated ageing study, packs are usually stored at 55°C. At this temperature a 6 week period is equivalent to 1 year of natural storage under normal (23°C) conditions. This method is suitable for pouches and blisters and for porous and non-porous packs.
A reference assessment of the seal strength and integrity of the packs is made at the outset. In this 'time zero' phase a group of products from the same batch (as those in the stability test) are used to provide benchmark data. This includes visual inspection, and any combination of sterile barrier tests such as burst testing, dye penetration testing and peel testing. Post-ageing inspection and tests are repeated at the desired time periods, and a comparative analysis is conducted to ascertain the effects of storage time.
Elevated temperatures and time periods to be used in a study can be custom-designed to meet your particular requirements. This online accelerated ageing calculator uses the formula given in ASTM F1980.