ABSTRACT
BACKGROUND The compendial sterility test is frequently presented as a flawed test for its stated purpose. This statement, of course, begs the question as to what exactly is the purpose of the sterility test as described in the compendia? 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 differed from the contemporary method in that it had the media incubated for five days rather than 14 and allowed two retests (all three had to fail to fail the test). However, the basic structure of the test is present.
