ASTM F2096-11 Standard Test Method for Detection of Gross Leakage in Packaging by Internal Pressurization (Bubble Test)

The ASTM F2096-11 standard published by the American Society for Testing and Materials (ASTM) defines a test method (bubble test) for detecting large leaks in packaging. This test method sensitivity is 81 percent.  possibly as low as 250 μm. The sensitivity of this test method has not been evaluated for use with porous materials or non-porous packaging other than spunbond polyolefin. This test method can be used for sachet packs. However, this test method is destructive as it requires entering the package to provide internal air pressure.

The standard in question does not purport to address all safety concerns, if any, of its use. It is therefore the responsibility of those implementing this standard to establish appropriate safety, health and environmental practices and to determine the applicability of regulatory restrictions prior to use.

The bubble leak test described in this standard is based on visual inspection of bubble flows resulting from a defect in the packaging or sterile barrier system. This test is performed by immersing the sample in water and applying light pressure. This destructive testing method is a practical method for examining packages for large leaks that could render the product non-sterile. This test method applies to very large or long packets that do not fit into any other packet integrity test method apparatus.

The intensity of the internal pressure for the package is determined by introducing a control defect created at a known location of the package. During the test, the pressure is gradually increased until it begins to show a steady stream of bubbles, indicating a fault area.

Generally, this test method is applied to detect large leaks in medical packages. The sensitivity of this method has been reduced to 250 μm. bubble leak test is a commonly used test method for evaluating sterile barrier integrity for pouches or thermoformed trays.

Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides standard testing services for the detection of gross leaks in packaging with internal pressurization, within the scope of ASTM F2096-11 standard, with its trained and expert staff and advanced technological equipment.