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

● The production time for casting prototypes can be shortened! Since model making is not required, the production time for prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly creating 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! Different products, such as similar shapes or variations in dimensions, can be created in a single molding process. This allows for the verification of multiple types in a short period.

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 affecting the base material with heat. 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.

This time, the ACS-5000 is available as a facial recognition terminal compatible with FaceMe Security's add-on feature "Face Terminal," enabling access control management that combines "advanced anti-spoofing features" with high-speed facial recognition powered by edge AI. ■ Main Features 1. Accelerated Authentication Processing FaceMe Security is optimized for the MediaTek Genio 700's NPU, achieving faster facial recognition processing and reduced CPU load compared to processing solely on the CPU. It ensures stable authentication without delays even during peak times such as clocking in and out, contributing to alleviating congestion. 2. Advanced "Anti-Spoofing" Optimized for the IR + RGB camera mounted on the ACS-5000, it can quickly detect fraudulent authentication using photos, videos, or 3D masks within 0.6 seconds, ensuring reliable identity verification. 3. Door Control Without Additional Equipment FaceMe Security can directly control the digital I/O of the ACS-5000, allowing for the construction of an access control management system without the need for additional equipment. This simplifies system configuration and reduces implementation costs.

This is an air leak tester for battery cases of electric vehicles (EVs). The battery case has the characteristic of being "large with a significant internal volume, and its structure may deform due to internal pressure." As a result, air leak testing generates "noise caused by its large size and capacity" and "noise caused by expansion or deformation due to internal pressurization." To mitigate this noise, this device features a newly developed smoothing function and a linear fitting correction function used in combination during measurement. Additionally, to achieve low-pressure control that is difficult to manage and to expand flow for large volumes, we provide a bypass box (CBU-600) equipped with an electro-pneumatic regulator for precise pressure control and a pressurization valve with a large effective diameter to supply high flow rates. Measurement methods: Work-Work comparison, Work-Master comparison, Fixed Master comparison Measurement pressure range: 10 kPa, 20 kPa, 50 kPa (depending on specifications) Gauge pressure sensor accuracy: ±2% F.S. Differential pressure sensor accuracy: ±0.5% F.S. Group settings: 0 to 31 groups Power supply voltage / Power consumption: AC100 to 240 V / 100 VA

● 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!