ASTM F2096 Bubble Test
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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.
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.
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For more details, please download the PDF document or feel free to contact us using the "Contact Us" section below.
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ASTM F2096 Bubble Test
[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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Japan Business Logistics Co., Ltd. (JBL) operated as a 100% subsidiary of IBM Japan, Ltd. until 2007, but after the execution date of the stock transfer on January 4, 2008, we will embark on a new journey as an affiliated company of Yasuda Warehouse Co., Ltd. (YASDA). Together with all our employees, we hope to become the most trusted and reliable partner for our customers and business partners, based on the specialized skills and know-how we have cultivated in IBM-related businesses, to achieve an efficient and rapid supply chain. At the same time, we aim to create a corporate culture based on compassion and trust, and we are committed to actively meeting your expectations.