Regulatory authorities worldwide regard the Sterile Barrier System (SBS) as an integral part of a medical device. Its primary function is to preserve sterility from manufacture through to use in clinical settings. Without it, the risks are clear: costly redesigns from failed testing, late-stage compliance issues, or compromised sterility that could lead to critical health risks and product recalls. Many organisations however lack in-house capabilities, or the deep understanding of ISO 11607 and associated ASTM standards needed to assess seal strength and integrity effectively – and knowing when to involve a lab can be just as unclear.

The specialists at the Eurofins Medical Device Services network of laboratories offer the insight, equipment, and processes to ensure that your sterile barrier system (SBS) meets regulatory expectations and performs as intended—protecting the device until the point of use. Working to ISO 11607, our GMP-compliant packaging laboratories offer a comprehensive suite of seal integrity and strength tests designed to evaluate both the presence of leaks and the durability of package seals. We tailor your test plan based on the material and intended use, regardless of whether you're designing packaging for a porous pouch, thermoformed tray, or non-porous unit pack. With decades of experience and access to state-of-the-art facilities, our scientists work with you to validate your final packaging design, ensure seal performance post-distribution, and confirm integrity across shelf life.