ABSTRACT
The compendial sterility test is frequently presented as a flawed test for its stated purpose. The test first appeared in 1932 [1] and included the basic features of the modern test—two media, prescribed dilution scheme (for bacteriostasis/fungistasis or method suitability), and a defined incubation time. The original test had the media incubated for 5 days and allowed two retests (all three tests had to demonstrate growth for the sterility test to fail). However, the basic structure of the test is present.
