ABSTRACT
The compendial sterility test is frequently presented as a flawed test for its stated purpose. The test first appeared in 1932 and included the basic features of the modern test—two media, prescribed dilution scheme, and a defined incubation time. There are two different Good Manufacturing Practices describing sterility testing in the United States. The harmonized test utilizes soybean–casein digest medium and fluid thioglycollate medium. These media and their corresponding incubation temperatures were chosen to maximize recovery of potential contaminants early in the development of the tests. Specific equipment for sterility testing also exists. The most obvious is the incubator. A laboratory performing mixed testing is well advised to have dedicated incubators at 20°–25°C and 30°–35°C for incubation of the sterility test samples. The sterility test is applied to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile.
