The test begins by setting the pressure gauge to 10+ 2 inches of water. A packaging port is attached to the center of the sample. A probe is inserted through the port. The package is then submersed into an immersion fluid and inflated. Evidence of bubble emission through the package is considered a failure.
Please see our
Packaging Validation matrix for more information.
“We depend very much on Nelson Labs and we have the highest confidence in you guys!”
Lou , Material Control Manager , Medical Device Manufacturer
Package Testing
Nelson Labs performs dye migration, seal peel, burst, and bubble emission package testing.
Minimum sample size: Complete packages
Recommended replicates: The number of test packages that are needed for this test are at the discretion of the sponsor. However, Nelson Labs recommends that at least 11 test packages be tested to make sure that the test is statistically significant.