Packaging - Burst test

Package integrity depends on overall structural strength - individual seal testing proves insufficient when package design might fail through bursting, material rupture, or seal failure under pressure encountered during sterilization, shipping, or handling. Burst testing per ISO 11607 and ASTM F1140 determines package strength through internal pressurization to failure identifying the weakest point and quantifying overall package robustness. This whole-package test captures cumulative effects of multiple seals, material strength, and package geometry revealing which component fails first under stress. Critical for validating package design ensuring adequate strength margins for intended sterilization and distribution, establishing process windows for seal parameters producing packages meeting strength requirements, and demonstrating packages withstand transportation and handling stresses without compromise. For medical device packaging, burst pressure data supports sterilization process validation ensuring packages survive steam autoclaving or ethylene oxide conditions, shipping validation confirming packages withstand altitude pressure changes and handling impacts, and design optimization identifying modifications improving package robustness. The test reveals weakest package areas whether seals, material body, or seal-material interface, enables material comparison evaluating strength differences between candidates, and validates that assembly processes don't introduce stress concentrations causing premature failure. Manufacturing process validation uses burst testing demonstrating consistent package strength across production, investigates process deviations when burst pressures fall outside specifications, and supports corrective action verification proving improvements achieve target strength increases.

No.
100810
Method
Internal pressurization to seal failure point
Analyses category
Sample type
Secondary packaging
Sample requirement (type)
Sterile or non sterile
Sample quantities
1 product
Equipment
Visual observation
Lead Time Standard (Days)
10
Lead Time Express (Days)
5
Lead Time Super Express (Days)
3
Accredited
Oui
Test facility
In House
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