Bacteriostasis & Fungistasis

  1. Turnaround time:        4 weeks

 

  1. Sample requirements:    at least 6 samples

 

USP <71>

In the Bacteriostasis & Fungistasis (B&F) study, low numbers of viable microorganisms are added to Trypticase Soy Broth & Fluid Thioglycollate Media containing the sterile medical device to confirm that the test item does not interfere with organism growth (bacteriostatic or fungistatic properties). This study should be performed on a medical device prior to a sterility test. This assay must reflect the actual sterility test methodology that will be used on the test article. It needs to be performed on new products or/and when any raw material changes are made during its manufacturing process.

European Biomedical Institute
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