ASTM F2096 Bubble Test

Over 300 medical device packaging validations per year! Leave the integrity testing of ISO 11607 sterile barrier systems to JBL.

Regarding the packaging and transportation of medical devices that enter the body (such as scalpels, catheters, syringes, etc.), it is necessary to demonstrate that they are sterile until the packaging is opened in the operating room or similar settings (ISO 11607:2019) and to submit and present test reports from a third-party organization. Therefore, when packaging and transporting medical devices, it is essential to conduct ISO 11607:2019 certification testing externally and obtain the test reports. Are you facing any of the following issues regarding ISO 11607 certification testing? - I want to obtain ISO 11607 certification, but I don't know what to do. - I was turned down for ISO 11607 certification testing and don't know where to request it. Based on our track record of over 300 validations of medical device packaging annually, we conduct performance testing of packaging systems in accordance with the testing methods described in Annex B Performance Testing of ISO 11607:2019. We provide a one-stop service from test plan development to test execution and report preparation, so please feel free to contact us for consultation. *For more details, please check the materials available for download in PDF format.

• Other packaging machines

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.

• Contract Inspection

● This is a leak testing device for small electronic components that does not use fluorinated inert liquids (PFAS-free). ● There is no longer a need for unstable visual confirmation through liquid immersion testing. It adopts a quantitative testing method that allows for stable pressure leak testing. ● It is a tabletop leak testing device specifically for gross leaks, with accuracy equal to or greater than that of liquid immersion testing. ● The detectable range is approximately 1×10⁻² Pa·m³/s to 1×10⁻⁶ Pa·m³/s (varies depending on the target product). ● It is suitable for sealed structures ranging from a few millimeters to a maximum of 80 × 70 mm. Please feel free to contact us for more information!

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact on the base material. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact to the base material. Repairs can be carried out even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact to the base material. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

● The production time for casting prototypes can be shortened! Since model production is not required, the time needed to create prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly producing sand molds from 3D data, there is no need for model production costs. If changes to the model are necessary, they can be addressed by modifying the 3D data. ● Similar products with different shapes and dimensions can be prototyped simultaneously! With one molding process, different products with similar shapes or varying dimensions can be molded at the same time. This allows for the verification of multiple types in a short period.