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Bacteriostasis & Fungistasis

Bacteriostasis & Fungistasis Test

To ensure the reliability of sterility tests, it is essential to demonstrate that the test product does not possess antimicrobial properties that could inhibit the detection of microorganisms. The Bacteriostasis & Fungistasis (B&F) test is a critical control within the sterility testing process, ensuring that any remaining microorganisms in a product remain detectable.

Test Method
The B&F test is performed by inoculating a sterile test medium, typically Trypticase Soy Broth (TSB) or Fluid Thioglycollate Medium (FTM), with representative test microorganisms. This medium is then brought into contact with the test product and incubated for 14 days at the prescribed temperatures:

  • For bacteria: 30 °C – 35 °C
  • For fungi and yeasts: 20 °C – 25 °C

During incubation, careful monitoring is conducted to verify whether the test organisms can multiply in the presence of the product. Successful microbial growth confirms that the test product does not have bacteriostatic or fungistatic properties that could influence sterility test results.

Thus, the B&F test serves as a crucial quality control step in sterility testing, contributing to the reliability of final test results.

Endotoxine testing

Frequently Asked Questions

11 sterile products are required for a standard B&F test used for the validation of the sterility test.