Burst test for packaging

The burst test determines package strength by pressurizing a package until it bursts.  This test method is defined in ASTM F1140 and conforms to ISO 11607 "Packaging for terminally sterilized medical devices."

Study Outline

Porous packages are prepared by placing tape over the porous surface to reduce the rate which air escapes.  The set up packages are used to experimentally determine the correct pressure, flow, and time required to burst the samples.  A probe is inserted into the sample package through a package port and the machine started.  The package inflates and bursts.  The machine records the burst pressure.  The burst failure location is also recorded.

Sample Requirements

Minimum per product type/lot: 11 samples + 3-5 set-up samples, 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 per product type/lot: 11 samples + 3-5 set-up samples, 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.