Accelerated ageing is used to simulate real shelf-life ageing and is therefore conducted to validate shelf-life claims. It is carried out according to ASTM F1980 Standard Guide for Accelerated Ageing of Sterile Medical Device Packages.

Packs are (usually) stored at 55°C and a 6 week period is equivalent to 1 year real time ageing under normal conditions. This method is suitable for pouches and blisters and for porous and non-porous packs.

The time when packs are admitted into ageing ovens usually triggers a "Time Zero" assessment of another group of products from the same non-aged batch in order to obtain bench mark data. This includes visual inspection and any combination of burst testing, dye penetration testing and peel testing. Post-ageing, inspection and tests are repeated and a comparative analysis is conducted between non-aged samples and aged samples at the time period(s) you have determined.

Ageing temperatures and protocols can be custom-designed to meet our clients' particular requirements.

Shelf Life validation