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

"ROBO TUBE" is a microtube with 1D/2D code that achieves excellent sealing and fitting properties. By integrating polypropylene and thermoplastic elastomer through one-shot molding, it realizes superior sealing and fitting. Compared to conventional microtubes, the opening and closing of the cap is very smooth, reducing the stress of cap operation. 【Features】 ■ The opening and closing of the cap is very smooth compared to conventional microtubes ■ Reduces the stress of cap operation ■ Innovative two-color molding of polypropylene and thermoplastic elastomer ■ Achieves excellent sealing and fitting properties ■ High compatibility with lab automation *For more details, please download the PDF or feel free to contact us.

We have unveiled two new products. 【Downflow Dust Collector (DFPRE Large Series)】 A packaged dust collector that combines productivity and practicality. It uses downward airflow to reduce filter load, leading to lower maintenance costs. Suitable for various industrial sectors including metal and machining, industrial applications, and waste recycling. 【Workstation Dust Collector (DBE Series)】 A dust collector integrated with a workstation, saving space. Recommended for dust control in manufacturing processes such as grinding, polishing, cutting, and finishing. It accommodates long and heavy workpieces. Applicable in various manufacturing processes including metalworking, aircraft parts manufacturing, automotive manufacturing, and industrial machinery manufacturing. For more details, please refer to the downloadable catalog or contact us. (C) Nippon Donaldson, Ltd. All rights reserved.

● To determine the sealing and waterproofing of sealed products based on pressure changes, it is not necessary to conduct tests that involve spraying water on the product or immersing it in water. ● Once the product is placed in a dedicated fixture within the inspection device, waterproofing can be quantitatively confirmed through automatic measurement. ● The target product size is W 300 × D 210 × H 100 mm or smaller. ● The target products include automotive cameras, smartphones, ECUs, small motors, and other packaging containers, and are effective for any products that require confirmation of sealing, waterproofing, and airtightness. ● For product specifications and details, please contact us.

In battery manufacturing lines, if components containing copper are used, there is a possibility that metal powder may mix in, dissolve, ionize, and pass through the separator, causing a malfunction that connects the positive and negative electrodes. Such minute metal powders may not be detected during pre-shipment inspections, and even if they are found, they can lead to various issues, such as the need to increase inspection processes to detect them. Therefore, Fukuda has developed a copper-free (all stainless steel) air leak tester that can be safely used in the production lines of battery manufacturers and secondary battery manufacturing equipment manufacturers. For product specifications and details, please refer to the "Related Product Information" and "Related Catalogs" below.

Introducing a "non-destructive testing device as an alternative to the submerged test" for pharmaceutical packaging products. "Complete vial leak testing device | MSQ-2002 series" Fully automating leak tests for various vials, bottles, eye drops, and cylindrical containers. Please check the link below for videos and catalogs.