For medical device manufacturers, evaluating the performance and integrity of sterile barrier systems is a key consideration in packaging. Obtaining COFRAC Testing Accreditation No. 1-10008 marks a new milestone for the Selenium Packaging laboratory in the development of its testing activities.
COFRAC accreditation for our testing of sterile barrier systems
Our Selenium Packaging laboratory has obtained COFRAC Testing Accreditation No. 1-10008 for the tests covered by its accreditation scope, dedicated to the evaluation of the performance and integrity of sterile barrier systems for medical devices.
This accreditation confirms the laboratory’s competence to perform the tests covered by its accreditation scope, in accordance with the requirements of NF EN ISO/IEC 17025:2017.
Tests covered by the accreditation
The Selenium Packaging laboratory now performs the following tests under accreditation:
- Seal strength – NF EN 868-5 Annex D and ASTM F88/F88M
- Peelability – NF EN 868-5 Annex E
- Dye penetration – ASTM F1929 and ASTM F3039
- Visual inspection – ASTM F1886
- Bubble test – ASTM F2096
- Aging in environmental chambers – ASTM F1980
These tests make it possible to evaluate the integrity of sterile barrier systems: seal performance, opening behavior, detection of defects or leaks, and changes in performance over time.
COFRAC Accreditation No. 1-10008 – Scope available at www.cofrac.fr.
A new step in the development of our laboratory expertise
Obtaining this accreditation is the result of work focusing in particular on the control of our equipment and test methods, the competence of our teams, and the traceability of our results.
For medical device manufacturers, this recognition provides an additional reference point when choosing a laboratory competent to perform these tests.
This new milestone is part of the development of our activities and demonstrates our continued commitment to the quality, reliability, and improvement of our services.
Are you developing, qualifying, or making changes to your sterile barrier system?
Our team is available to discuss your testing needs in accordance with the requirements of ISO 11607-1.
