by Bryan Brezoff, ID’s Section Leader, BS, SM RM(NRCM) & Jacob Lee, B&F Study Director, BS, RM(NRCM)
Most people are aware of the need to meet the USP<71> standard test of sterility, but they are quite often less aware of the included B&F requirement—B&F meaning Bacteriostasis and Fungistasis (also referred to as method suitability or sterility validation). Manufacturers need to be aware of this test to ensure their products meet the sterility validation requirements.