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Product Bioburden Validation - Adverse Substance Screen Test

Bioburden Inhibition Enhancement Bioburden validation Product enhancement

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#1 rtiongson



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Posted 02 June 2014 - 12:00 PM


We have a new product (medical device) that we're trying to validate the bioburden method, to do so we have to do adverse substance screen tests, recovery factor and routine bioburden method. We have initially cut the product (which exposes the internal metal parts) when doing the adverse substance screening test and results shows that there is some enhancement occuring with the device. A re-test was conducted with just coiling the device (not cutting therefore not exposing metal materials) but its still showing some enhancement.


Does anyone know or can guide me where to go for list of materials that would cause microorganism enhancement (as well as inhibition)? The re-test units were extracted invidually by coiling the device and submersing in 600 mL extraction fluid in a sterile bag. Shaken for 30 min at 150 rpm.


Any help would be much appreciated, any guidance on how to solve this enhancement issue?




Also tagged with one or more of these keywords: Bioburden, Inhibition, Enhancement, Bioburden validation, Product enhancement

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