Medical Device Packaging Integrity Testing
Are you looking for a medical device packaging integrity testing solution? As part of your validation process your packaging needs to meet the requirements to ensure sterile seal integrity and protect your device and the end user.
Sepha offers two non-destructive and deterministic 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.
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.