Bubble emission

The bubble emission test is used to determine package integrity.  This test method covers the bubble emission test as defined in ASTM 2096-04.  This test method conforms to the standard covered in ISO 11607 "Packaging for terminally sterilized medical devices".

Study Outline

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.

Sample Requirements

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.

Nelson Experts:

• Erika Diaz 801-290-7841, 800-826-2088

Sample Requirements

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.