ASTM F1980 Testing — Laboratories & Overview
ASTM F1980 guides time-related aging evaluation of sterile barrier systems. Real-time studies must confirm accelerated results; aging does not replace distribution, package-integrity or material-device interaction evaluation.
When is it used?
- Shelf-life substantiation for sterile packaging
- Packaging or material changes
- New product submissions
Sample considerations
- Accelerated conditions and equivalent real time are calculated from the guide's approach and the claimed shelf life.
- Real-time aging is normally run in parallel.