Sercovam is part of SGS, the world's leading inspection, verification, testing and certification company.
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SGS SERCOVAM Cestas
BP 10 - 33611 CESTAS - FRANCE
T +33 (0) 5 57 97 02 33
F +33 (0) 5 57 83 53 73
SGS SERCOVAM Etupes
BP 61059 - 25460 ETUPES - FRANCE
T +33 (0) 3 81 32 24 30
F +33 (0) 3 81 32 22 62
Validation of medical devices packaging with sterile barrier
SGS SERCOVAM laboratories complete their offer on the validation of sterile medical devices packaging complying with ASTM F2096 (ASTMF2096) ) [Detecting Gross leaks in Packaging by internal Pressurization (Bubble test)] and ASTM D3078 (ASTMD3078) [Determination of Leaks in Flexible Packaging by Bubble Emission] standards. SGS SERCOVAM is already involved in the validation of your packaging such as blisters, bags… according to ISO 11607 (ISO11607) specifications with seal strength tests as per NF EN 868-5 (NFEN868-5), integrity tests as per ASTM F1929 (ASTMF1929) and peelability tests. Moreover, our laboratories have integrated new ICH pharmaceutical chambers. They are completing a fleet of more than 100 chambers to run accelerated aging tests on medical packaging according to ASTM F1980 (ASTMF1980). In addition, our teams run oxygen permeability tests according to ASTM F2622, ASTM D3985 and ASTM F1307, and water vapor permeability or saturated vapor of certain fluids permeability according to NF ISO 2528 (NFISO2528) or American Pharmacopoeia (USP). These tests are performed on pill-box, films or other packaging. Finally, our mechanical endurance laboratory implements the testing to simulate transport or distribution system (road transport, air freight, rail transport) according to ASTM D4169, ISTA 1A, ISTA 1G, ISTA 2A, ISTA 3A.