ASTM F2096 Bubble Test

日本ビジネスロジスティクス（JBL）藤沢北事業所

[Test Overview] The bubble leak test uses a testing method compliant with ASTM F2096 standards, submerging sealed packages underwater and applying internal pressure to detect the presence of leaks in non-porous and porous packaging. In particular, in the medical device field where confirmation of the integrity of sterilized packaging is required, we provide highly reliable test results. [Test Equipment] Leak Tester: Sun Science FKT-100 (maximum pressure 0.07 MPa) Testing Water Tanks: - Small: 585 × 435 × 435(h) mm - Medium: 1,775 × 430 × 420(h) mm - Large: 840 × 840 × 425(h) mm *The feasibility of testing will be determined based on the size and shape of the packaging. Please feel free to consult us for details. [Benefits of Requesting Our Services] Highly reliable testing compliant with ASTM standards Numerous achievements in the medical and pharmaceutical industries Ideal for evaluating the validity of packaging design and quality assurance activities Quick response and flexible adjustment of testing conditions are possible.

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Performance Testing of Packaging Systems for Medical Devices (ISO 11607)
Over 300 medical device packaging validations per year! Leave the integrity testing of ISO 11607 sterile barrier systems to JBL.

By using our services, you can gain the following benefits: ◇ We provide a one-stop solution from transportation testing to the integrity evaluation of sterile barrier systems, which shortens the product development lead time and enables early entry into domestic and international markets. ◇ With the extensive support of packaging experts, you can focus on your core business. JBL conducts over 300 validations of medical device packaging annually and is a skilled group with extensive knowledge and experience. We have many ISTA-certified CPLP technologists and technicians in-house, and we gather the latest information through our alliance with ISTA to assist with your testing needs.
ASTM F2096 Bubble Test
The bubble test specified in ASTM F2096 (for detecting large leaks) can be performed.

[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.