Shanghai SUNGO Lab
Hefei SUNGO Lab
Sterile barrier system integrity and seal strength validation
The packaging of a sterile medical device is the barrier that maintains sterility until the point of use. We provide complete validation of the sterile barrier system, including seal strength, peel strength, dye penetration, bubble leak and vacuum leak integrity testing, confirming that the package maintains sterility throughout the product shelf life.
Packaging for terminally sterilized medical devices
Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test)
Standard test method for detecting seal leaks in porous medical packaging by dye penetration
Standard test method for seal strength of flexible barrier materials
Standard test methods for internal pressurization failure resistance of unrestrained packages
Test methods for sterile medical device packages
T-peel test to determine package seal strength
180-degree peel test to evaluate sealing performance
Dye solution penetration to detect small package leaks
Bubble test to detect package seal integrity
Vacuum decay method for package leak detection
Microbial challenge test to evaluate the microbial barrier of the package