Burst Testing
Definition
Burst testing is often used in the medical device industry and others to measure and quantify the strength Medical Device Package Sterile Barrier Systems as well as other sealed flexible packagesMeaning of Test
This quantitative test is useful for measuring the ability of a Sterile Barrier System to withstand rapid internal pressurization by yielding an ultimate failure pressure. throughout the validation process including material selection, sealer validation, sterilization validation as well as shelf life validation. The burst strength peak value recorded is useful in determining if challenges or aging time have reduced a packages strength. Properly applied in a package validation test plan (within the guidelines of ANSI/AAMI/ISO 11607-1:2006) this test is useful to quantify negative effects of hazards on the Sterile Barrier System. The test does not determine the Sterile Barrier Systems ability to maintain a sterile barrier.
Typical Range
Typical burst test values range from 10 to 20 psi. This burst strength value will vary depending on the aspect ratio of the package, its material, and whether or not the package was restrained.
Associated Standards
Burst Strength Tests typically reference either ASTM F1140 or ASTM F2054. Both of these standards measure the ultimate pressure at failure, however, F1140 describes the unrestrained method while F2054 requires restraint of the Sterile Barrier System. A closed pouch, restrained test is recommended when possible (ASTM F2054) to minimize the variation across different sized or types of packages. An alternative method for quantitatively measuring strength of the Sterile Barrier System is the seal peel test explained further in ASTM F88.
What We Provide
Westpak provides burst tests for wide variety of package sizes, types, on both pouches and trays using either method to meet your requirements.
Standards at a glance
- ASTM F1140
- ASTM F2054
