Bubble emission

The bubble emission test is used to determine the 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 instrument is set to 50% of the lowest burst pressure from a previous burst test or pressure requested by the sponsor.  For porus packages, the instrument is set to 0.5 psig.  A probe is inserted into the samples package and the machine started.  The package is submerged in an immersion fluid for a specific time.  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:

• Jennifer Gygi 801-290-7847, 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.