Medical Device Packaging 'Integrity Testing Service'

One-stop support from transportation testing to the integrity evaluation of the sterile barrier system! Achieving a reduction in product development lead time.

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.

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By using our services, you can gain the following benefits: ◇ We provide a one-stop solution from transportation testing to the integrity evaluation of sterile barrier systems. This enables a reduction in product development lead times and allows for early entry into domestic and international markets. ◇ With the extensive support of packaging experts, you can focus on your core business. JBL conducts over 300 validations of medical device packaging annually and is a skilled group with extensive knowledge and experience. We have many ISTA-certified ISTA CPLP technologists and technicians on staff, and we gather the latest information through our alliance with ISTA to assist with your testing needs.