日本ビジネスロジスティクス（JBL） List of Products and Services

Japan Business Logistics (hereinafter referred to as JBL) is well-equipped with a balanced range of various facilities necessary for testing, such as large testing equipment and forklifts, enabling comprehensive support for various packaging tests including vibration, drop, impact, compression, decompression, and temperature and humidity. We also conduct testing evaluations based on official testing standards such as JIS, ISO, ASTM, ISTA, and IEC. Additionally, we specialize in packaging system validation for medical devices, offering a one-stop service from transportation simulation tests to the integrity evaluation of sterilization barrier systems in accordance with ISO 11607-1. 【Main Testing Items】 ■ Vibration Testing (Long Duration Continuous Operation) ■ Altitude Testing / Decompression Testing ■ Impact Testing ■ Horizontal Impact Testing ■ Drop Testing ■ Compression Testing ■ Packaging System Performance Testing ■ Stability Testing ■ Integrity Testing ■ ISTA Testing Package Certification Service ■ ISO 11607-1 Packaging Validation Service * For more details, please download the PDF document (recommended). * Customers in a hurry, please contact us via the 'Inquiry' section below.

We will conduct packaging tests tailored to your needs in accordance with the test sequences specified in "ASTM D4169/ASTM D7386," one of the many transportation packaging test standards that have been referenced in the United States for a long time. The international standard for sterilization packaging in medical devices, ISO 11607 (JIS T8041), recommends these performance tests for packaging. 【Test Types】 ■ General Guidelines ■ Drop and Impact Tests ■ Vibration Tests ■ Horizontal and Incline Tests ■ Unit Load Tests ■ Compression Tests ▼ For more details, please download the PDF materials (recommended). ▼ If you need assistance urgently, please contact us through the 'Inquiry' section below.

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.

Due to the change from the Medical Devices Directive (MDD) to the Medical Devices Regulation (MDR), ISO 11607:2019 has made packaging validation a clear requirement. As a result of this change, integrity testing of sterile barrier systems must be conducted after performance testing of the packaging system and after stability testing. Our service provides a one-stop solution for all necessary tests, from transportation packaging testing to integrity testing of sterile barrier systems and stability testing. This allows you to be freed from the cumbersome ancillary tasks and complicated communications related to inter-site transportation, enabling rapid packaging validation. ▼ For more details, please download the PDF document (recommended). ▼ If you need assistance urgently, please contact us through the 'Inquiry' section below.

Stability testing is necessary for products whose quality is difficult to ensure without specific storage methods or that may deteriorate over time, according to the guidelines issued by the Ministry of Health, Labour and Welfare, which require stability testing to establish storage methods and shelf life. Our service will conduct accelerated degradation testing (ASTM F1980) in accordance with the standard guide for accelerated degradation of sterilized medical device packaging as described in Annex B of ISO 11607-1:2019. ▼ For more details, please download the PDF document (recommended). ▼ For urgent inquiries, please contact us using the 'Contact Us' section below.

Due to the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), packaging validation has become a clear requirement in ISO 11607:2019. As a result of this change, integrity testing of sterile barrier systems must be conducted after performance testing of the packaging system and after stability testing. Additionally, devices shipped in a sterile state must guarantee that they are in a sterile condition when they reach the market and must maintain sterility under the transportation and storage conditions specified by the manufacturer until they are opened at the time of use, unless the packaging is damaged. Our service will conduct integrity testing of medical device packaging in accordance with the testing methods described in Annex B of ISO 11607:2019. ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us through the 'Contact Us' section below.

- 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.

- This test is a method established by ASTM to evaluate the seal strength of soft barrier materials. - 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." Annex B of this standard describes ASTM F88 as the standard test method for evaluating the seal integrity of medical packaging. - There are three methods for measuring seal strength: 1) Technique A: No support 2) Technique B: Supported at 90 degrees by hand 3) Technique C: Supported at 180 degrees ▼ For more details, please download the PDF document (recommended). ▼ If you need immediate assistance, please contact us using the 'Contact Us' section below.

- This test is a method established by ASTM to detect seal leaks in medical packaging using a dye penetration solution. - The dye is applied to the seal area between transparent materials and porous sheet materials, and the presence or absence of defects (leaks) in the channels is visually confirmed. - 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." Annex B of this standard describes ASTM F1929 as the standard test method for evaluating seal integrity in medical packaging. - This test method is recognized by the FDA as a consensus standard. ▼ For more details, please download the PDF document (recommended). ▼ If you need immediate assistance, please contact us using the "Contact Us" option below.

This testing method is established by ASTM (American Society for Testing and Materials) to visually measure the presence of defects that may affect the integrity of packaging. It is a test to visually evaluate the appearance of seals on unopened, undamaged packaging that has at least one transparent side where the seal area is clearly visible. ▼ For more details, please download the PDF document (recommended). ▼ If you need immediate assistance, please contact us using the 'Contact Us' section below.

The document consists of two parts: the main body and the annexes. The main body is created based on ISO 4180, with technical content modified to reflect Japan's unique circumstances, while Annexes A and B are presented without changes to the content of ISO 4180: 2009. (Currently, ISO 4180: 2019 has been issued, so it is recommended to refer to the latest version for the application of Annex A unless there are special reasons.) ▼ For more details, please download the PDF materials. (Recommended) ▼ If you need immediate assistance, please contact us using the "Contact Us" section below.

The international standard equivalent to JIS Z 0200 "Packaging of Goods - General Test Methods" which serves as the standard for transportation packaging in our country is ISO 4180, and it is one of the widely adopted transportation testing standards around the world, similar to ASTM and ISTA standards. The testing content and conditions of this standard were significantly revised for the first time in approximately 10 years since 2009, and it was published as the 2019 edition. ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us using the 'Contact Us' section below.

One of the most widely referenced transportation packaging test standards in the United States for an extended period. It specifies ten types of hazard factors during transportation and structures the overall test to match real transport environments. The tests are classified into 18 Distribution Cycle (DC) categories based on the shape, weight, and mode of transportation of the packaged goods, from which selections are made to conduct tests according to the procedures. There are three levels of assurance (test severity), and the test conditions vary depending on the level, such as the strength (Grms) in vibration tests and drop height. ▼ For more details, please download the PDF document (recommended). ▼ For urgent inquiries, please contact us using the 'Contact Us' section below.

The ASTM D4169 test was issued in March 2008, focusing on Single Parcels weighing 68 kg or less. It defines eight types of hazard factors during transportation and structures the overall test to match real transportation environments. Packaged goods are categorized into four categories based on shape, weight, and volume (1 small, 2 flat, 3 long and narrow, 4 all others), and testing is conducted according to the procedures determined by the identified cargo category. The guarantee level is divided into three stages. ▼ For more details, please download the PDF document (recommended). ▼ If you need immediate assistance, please contact us via the 'Inquiry' section below.

ISTA is one of the international standards widely adopted around the world for the evaluation testing of packaged goods, similar to ISO and ASTM. In recent years, its presence has particularly increased in Southeast Asia and China, with more companies adopting ISTA testing standards as their internal standards. Additionally, the international standard for sterilization packaging in medical devices, ISO11607 (JIS T8041), recommends ISTA testing as one of the options for evaluating packaging performance. Our testing lab was accredited by ISTA in December 2010 and conducts packaging tests tailored to customer needs in accordance with the testing sequences specified by ISTA. ▼ For more details, please download the PDF document (recommended). ▼ For urgent inquiries, please contact us using the 'Contact Us' link below.

We will conduct the real-time aging test described in section 8.3 of ISO 11607-1 (Requirements for sterile barrier systems and packaging systems). ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us using the 'Contact Us' section below.

The Good Distribution Practice (GDP) guidelines for pharmaceuticals emphasize the assurance of quality throughout all distribution processes from the manufacturing of pharmaceuticals to their delivery to patients, with particular importance placed on temperature control. Especially for temperature-sensitive pharmaceuticals (such as biopharmaceuticals), there is an increasing demand for strict temperature management, leading to a rise in companies adopting insulated containers. In our service, we apply the ISTA-7D testing standard, which has seen a growing demand in recent years, as a method for evaluating insulated containers. We conduct transportation temperature simulation tests for insulated containers as well as temperature measurements inside the insulated containers. ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us via the 'Contact Us' section below.

The vibration test for medical pen-type injectors according to ISO 11608-1:2012 is a vibration test defined by the requirements and testing methods. As a pre-treatment for the vibration of the pen-type injector, the injector, equipped with a cartridge and a dedicated injection needle, is subjected to vibrations in each direction of the three axes under JIS C 60068-2-6 and the following conditions. ▼ For more details, please download the PDF document (recommended). ▼ Customers in a hurry, please contact us using the 'Contact Us' section below.

Our company flexibly responds to various tests tailored to our customers' transportation modes, including tests assuming transportation by truck, aircraft, and ship, compression tests assuming stacking in warehouses, and tests related to sterilized medical device packaging. We provide consistent support from the planning of test programs to the execution of tests and the preparation of reports, and we also accommodate tests in accordance with the revised "JIS Z 0200" standard, which was amended in January 2023. Currently, we are offering a "Packaging Evaluation Test Case Collection" that includes our expertise in conducting over 800 transportation packaging tests annually and information on tests based on the revised "JIS Z 0200." [Contents (excerpt)] ■ Details of standard tests such as ASTM, ISO, ISTA, and JIS ■ Important points to consider in packaging design before testing ■ Overview of packaging validation services (stability tests, accelerated degradation tests, etc.) ■ Overview of temperature simulation tests for insulated containers *For more details, please refer to the materials available for download in PDF format. If you need immediate assistance, please contact us using the 'Contact Us' section below.

Our company flexibly responds to various tests tailored to our customers' transportation modes, including tests assuming transport by truck, aircraft, and ship, compression tests assuming stacking in warehouses, and tests related to sterilized medical device packaging. We provide consistent support from test planning to execution and report preparation, and we also accommodate tests in accordance with the revised "JIS Z 0200" standard, which was amended in January 2023. Currently, we are offering a "Packaging Evaluation Test Case Collection" that includes our know-how from conducting over 800 transportation packaging tests annually, as well as test information based on the revised "JIS Z 0200." [Contents (excerpt)] - Details of standard tests such as ASTM, ISO, ISTA, and JIS - Key points to consider in packaging design before testing - Overview of packaging validation services (stability tests, accelerated degradation tests, etc.) - Overview of temperature simulation tests for insulated containers *For more details, please refer to the materials available for "PDF Download." If you need immediate assistance, please contact us through the "Contact Us" section below.