ASTM F2096 Bubble Test

The bubble test specified in ASTM F2096 (for detecting large leaks) can be performed.

- This test is a method established by ASTM for detecting leaks in sealed packaging by internally pressurizing the package. - The purpose of this test is to detect gross leaks in non-porous and porous packaging. - Specifically, the sealed package is submerged to a certain depth below the water surface and inflated at a predetermined pressure. Bubble formation is then observed to visually confirm the presence and location of any gross leaks. - ISO 11607-1 states that as part of packaging system performance testing, "the integrity of the sterilization barrier system must be demonstrated after sterilization and subsequent performance testing." Its Annex B describes ASTM F2096 as the standard test method for evaluating the seal integrity of medical packaging. ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us via the 'Inquiry' section below.

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basic information

[Test Procedure] ・Test Method A: Nonporous Packaging Insert the air supply tube of the pressure gauge into the test specimen, submerge it about 1 inch underwater, and supply air until the set pressure is reached. Then, thoroughly check for any holes on the top surface of the packaging where bubbles are escaping. Rotate the test specimen 180 degrees and perform the same test on the opposite side. ・Test Method B: Porous Packaging Insert the air supply tube of the pressure gauge into the test specimen, submerge it about 1 inch underwater, and leave it for at least 5 seconds before supplying air until the set pressure is reached. Then, thoroughly check for any holes on the top surface of the packaging where bubbles are escaping. Rotate the test specimen 180 degrees and perform the same test on the opposite side.