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

Fukuda Corporation has been pursuing leak detection for 60 years and is dedicated to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing performance. We will propose suitable testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

This is a collection of links to Fukuda's technical columns. It covers various topics related to leak tests and more... Please check the related links for more information.

The hyper CLT sheets come in two sizes: 5×10 and 5×20. Key points for selection include the size of the site, the installation location, the heavy machinery used, and the frequency of replacement. The 5×10 sheet measures approximately 1.5m × 3m and weighs about 230kg. It is easy to handle even with small machinery, making it suitable for sites where partial installation is desired, such as worker pathways, around rest areas, material yards, and temporary parking lots. A 10-ton truck can carry up to 40 sheets, which also enhances transportation efficiency. On the other hand, the 5×20 sheet measures approximately 1.5m × 6m and weighs about 460kg. It can cover a large area with a single sheet, making it suitable for long access roads, temporary roads, and spacious heavy machinery work yards. It is also characterized by its ability to reduce seams. In some cases, combining both sizes can be an effective approach. The hyper CLT sheets are civil engineering CLT materials utilizing wood and are registered with the Ministry of Land, Infrastructure, Transport and Tourism under the NETIS technology "TH-250021-A." Choosing the right size according to site conditions can enhance workability and usability.

Metal cracks are one of the concerns in equipment maintenance operations. Conventional welding methods for repairs can change the base material around the crack due to heat, leading to residual stress and deformation, which always carries the risk of "crack recurrence" and "secondary damage." Hinode Waterworks Equipment Co., Ltd.'s "Mechanical Stitching Method" is a new technique that allows for metal crack repairs without applying heat. By using special bolts and reinforcement plates, the crack is physically removed without affecting the base material at all. Repairs can be made 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 or download the catalog.

Japan is among the top 10 countries in the world with frequent earthquakes. The 2020 White Paper on Land, Infrastructure, Transport and Tourism has also reported an increase in the probability of significant earthquakes occurring. For the Nankai Trough earthquake, the probability of an earthquake with a magnitude of 8 to 9 occurring within the next 30 years is estimated to be 70 to 80%. At Hotron, we recommend the introduction of seismic devices for earthquake measures in buildings and equipment. The seismic device 'HK-2' is a product that automatically performs various controls that have been pre-set when it detects strong shaking equivalent to a seismic intensity of 5 lower or higher. For example, it can automatically execute actions such as: "Open automatic doors and gates to secure evacuation routes and access for emergency vehicles" "Transmit signals to the control room and stop facility equipment" "Unlock the keys to locked lockers" "Automatically play voice guidance" ◎ For more details, please download the materials or contact us.