USP 71 Sterility Test

EUROLAB laboratory provides testing and compliance service within the scope of USP 71 standard. This standard requires sterility testing for routine release testing as well as the sterilization verification process.

Membrane Filtration Sterility Test is the preferred method for pharmaceutical products. A suitable use of this test is for devices that contain a preservative and are bacteriostatic and fungistatic under the direct transfer method.

With membrane filtration, the concept is that microorganisms collect on the surface of a submicron pore size filter. This filter is partitioned and transferred to the appropriate medium.

This standard is the preferred method for medical devices because the device is in direct contact with the test medium during the incubation period. Living microorganisms that can remain in or on the product after sterilization have an ideal environment to grow and multiply in it. This is especially true for damaged microorganisms where the damage is caused by the non-lethal sterilization process.

All microorganisms have biological repair mechanisms that can take advantage of environmental conditions conducive to growth. The direct transfer method benefits these damaged microorganisms. The entire product should be immersed in the test liquid. In large devices, the patient contact areas should be immersed.

EUROLAB assists manufacturers with USP 71 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.