Medical Device Packaging Integrity Testing
Are you looking for a medical device packaging integrity testing solution? When packaging sterile devices, seal integrity testing can help you to ensure product sterility & efficacy, and shelf life.
Sepha offers two non-destructive, deterministic and reliable leak test solutions that can be run in compliance with 21 CFR Part 11.
A tool-less package leak tester that has been developed to detect leaks as small as 10µm within 20 seconds.
- Multi-Q with Flexible Membrane
The Multi-Q with hybrid membrane technology works in combination with vacuum decay testing according to the ASTM F2338-09 standard test method. The flexibility of the membrane makes it suitable to test different shapes and sizes and more intricate package designs.