Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and can be performed in an isolator or cleanroom environment.

Are used for sterility testing?

Pharmaceutical Sterility Testing Methods

Fluid thioglycolate medium (FTM) is typically used to culture anaerobic and some aerobic bacteria, while soybean casein digest medium (SCDM) is typically used to culture fungi and aerobic bacteria.

Why is validation of sterility test done?

The Objective of this validation is to establish documented evidence that the test for sterility by membrane filtration method will produce the consistent results when analyzed as per the Standard Operating Procedure.