Bacteriostasis & Fungostasis
1. Turnaround time: 4 weeks
2. Sample Requirements: at least 6 samples
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.