Securing the Final Mile: Sterile Barrier System (SBS) Testing
For medical devices requiring sterilization, packaging is more than just a container; it is the critical barrier ensuring the product remains sterile from the manufacturing floor to the operating room. The integrity of the Sterile Barrier System (SBS) is directly linked to patient safety. Weshin Inspection Tech provides testing services compliant with ISO 11607, ensuring your packaging system remains impenetrable throughout transportation and storage.
What is ISO 11607?
ISO 11607 is the globally recognized standard for "Packaging for terminally sterilized medical devices," divided into two parts:
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Requirements for Materials and Systems: Evaluating the physical and chemical properties of packaging materials.
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Validation for Forming and Performance: Ensuring the packaging maintains its sterile barrier function after sterilization, transit shocks, and aging.
Key Testing Items
We employ rigorous experimental methodologies to verify packaging reliability:
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Integrity Testing:
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Dye Penetration Test: Detecting micro-channels or leaks within the package seals.
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Bubble Emission Test: Identifying microscopic leaks through differential pressure.
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Strength Testing:
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Peel Strength Test: Measuring the force required to open a seal, ensuring it provides both security and aseptic presentation.
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Accelerated Aging:
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Simulating long-term stability under storage conditions to confirm that the packaging does not degrade within its labeled shelf life.
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