Shanghai SUNGO Lab
Hefei SUNGO Lab
Accelerated and real-time ageing to establish product shelf life
Shelf life validation establishes the expiry date of a medical device. Working to ASTM F1980 and ISO 11607, we provide accelerated ageing and real-time ageing services, deriving shelf life from a defensible ageing model to support registration and market release.
Standard guide for accelerated aging of sterile barrier systems for medical devices
Packaging for terminally sterilized medical devices
Stability testing of new drug substances and products
Test methods for sterile medical device packages
Accelerated ageing at elevated temperature to derive shelf life
Real-time ageing validation under ambient conditions
Sterile barrier system integrity before and after ageing
Change in seal strength before and after ageing
Retention of sterility before and after ageing
Stability study protocol design and shelf life determination strategy