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  1. Home
  2. Testing, Analysis and Measurement
  3. 日本ビジネスロジスティクス(JBL) 藤沢北事業所
  4. ASTM F2096 Bubble Test
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  • Oct 07, 2025
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Oct 07, 2025

ASTM F2096 Bubble Test

日本ビジネスロジスティクス(JBL) 日本ビジネスロジスティクス(JBL) 藤沢北事業所
[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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121.医療機器包装 包装システム性能試験サービス.jpg

Performance Testing of Packaging Systems for Medical Devices (ISO 11607)

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.

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41.ASTM F2096 バブル試験.jpg

ASTM F2096 Bubble Test

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.

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Related catalog(4)

Medical Device Packaging Validation Services

Medical Device Packaging Validation Services

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Medical Device Packaging Integrity Testing Services

Medical Device Packaging Integrity Testing Services

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Medical Device Packaging - Packaging System Performance Testing Services

Medical Device Packaging - Packaging System Performance Testing Services

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Medical Device Packaging Stability Testing Services

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日本ビジネスロジスティクス(JBL)
Testing, Analysis and Measurement
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CCS3 product photo

The new product "Vehicle Count Sensor CCS3" enables efficient occupancy management of large parking lots.

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Hotron Inc. has launched its new product, the "Vehicle Count Sensor CCS3"! This product is a ceiling-mounted sensor that combines infrared and radar technology. It reliably detects vehicles in both directions with a single unit, accommodating traffic during congestion and vehicle passing, thus achieving efficient occupancy management in large parking lots. Additionally, it can be utilized for exit warning purposes in addition to vehicle counting, contributing to the safe and smooth operation of parking facilities. 'Features' - Improved detection performance against changes in road surface during rainy weather by using both infrared and radar. - Equipped with IP67 waterproof and dustproof performance, making it effective even in salt damage areas. - Various settings can be configured from a dedicated app (for Android devices), with current settings easily understandable at a glance. - The base dimensions are the same as the previous model "CCS2," allowing for smooth replacement of existing equipment. *For more details, please refer to the product information, catalog download, or contact us.*

Oct 16, 2026

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Hyper CLT flooring panel

Public works enter the era of "mandatory NETIS" | Hyper CLT flooring

  • NEW
  • PRODUCT

In projects directly managed by the Ministry of Land, Infrastructure, Transport and Tourism, the use of new technologies is generally required. Therefore, in future civil engineering sites, it is important not only to consider "whether to use new technologies," but also how to select and utilize technologies that are suitable for the site. One of those options is the "Hyper CLT Board," a wooden lightweight mat that utilizes CLT. It can be used as a wooden mat for temporary roads, access routes, and heavy machinery work yards, and the 5×10 board weighs approximately 230 kg, making it relatively lightweight. In addition to ease of installation, removal, and relocation, it features suppression of glare and metallic sounds, as well as environmental considerations through the use of wood. Furthermore, it can be incorporated into proposals for the utilization of new technologies as a **NETIS registered technology by the Ministry of Land, Infrastructure, Transport and Tourism "TH-250021-A."** NETIS, new technologies, civil engineering, CLT. As public works change, the Hyper CLT Board offers a new option of wooden lightweight mats to the site.

Oct 16, 2026

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Metal Crack Repair: MS Method for Repairing Cracks and Fractures in Machinery Equipment

  • NEW
  • PRODUCT

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.

Oct 16, 2026

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[Video Manual Guide] We will clearly explain how to connect the wireless set that links the bed exit sensor and nurse call system through video!

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  • OTHER

Hotron, which manufactures and sells sensors, provides bed exit sensors for hospitals, nursing, and care facilities. Hotron offers easy-to-understand video guidance on how to use the bed exit sensors wirelessly and how to set up device connections! ▼ Video Manual (YouTube) https://www.youtube.com/playlist?list=PLNVA4mTrZDqtJa6MfFRZQxwtfCSnAfxVy 【Bed Exit Sensors】 ○ Non-contact infrared sensor, simply place it - Pole-kun HB-H1 ○ Mat sensor, foldable thin mat - Mat-kun HB-UST ○ Body movement call - Ugo-kun HB-TV3 ○ Body movement call for wheelchairs - Ayumi-chan HB-WTV3 【Options】 ○ Nurse call linked wireless set - Wireless set (transmitter/receiver) HB-RS/HB-RJ ◎ For more information about the products, please contact us or download the catalog.

Oct 15, 2026

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AAEON Intel N250/N150 equipped ultra-compact industrial fanless PC [BOXER-6407-TWL]

  • NEW
  • PRODUCT

Features: ● Equipped with Intel N series processors (N250/N150) ● Fanless design ● Ultra-thin compact chassis (30mm thick) ● Supports DDR5 memory ● Dual display output ● Dual Gigabit LAN ● Abundant M.2 expansion slots ● Equipped with TPM 2.0 * This model comes without memory, storage, and OS.

Oct 15, 2026

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