EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of ASTM F1608 testing. This test method is used to determine the migration of airborne bacteria through porous materials intended for use in packaging sterile medical devices.
This test method is designed to test materials under conditions that cause detectable passage of bacterial spores through the test material.
A rotational study was conducted in which eleven laboratories participated. Each laboratory tested two replicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV). Materials tested under the standard conditions described in this test method gave average values ranging from LRV 1,7 to 4,3.
The results of this translational study suggest that care should be taken when sorting test data and materials, especially when small numbers of sample replicates are used. Additionally, more collaborative work should be performed before this testing method is considered adequate for the purpose of setting performance standards.
The exposure chamber method is a quantitative procedure to determine the microbial barrier properties of porous materials under conditions determined by testing. Data from this test are useful in evaluating the relative potential of a particular porous material to contribute to loss of sterility of the contents of the package compared to another porous material. This test method is not intended to predict the performance of a particular material in a particular sterile packaging application.
The bacterial challenge (number and type of microorganisms) that the packaging will encounter during distribution and use. This may be affected by factors such as shipping methods, expected shelf life, geographic location and storage conditions.
EUROLAB assists manufacturers with ASTM F1608 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.
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