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The compendial Sterility Test first appeared in recognizable form in the British Pharmacopeia in 1932 and then in the USP in 1935 as a direct response to a clear need for a recognized test to check for pharmaceutical product sterility. Since this time, the design of the test has remained fundamentally unchanged although there has been refinements in the actual test design ending with its international harmonization in 2003. What we call the “Sterility Test” is more appropriate titled “Sterility Tests” in the compendia as the chapter includes two distinct types of testing, one utilizing membrane filtration and the second a direct transfer of the medicine into recovery media for recovery. The concerns discussed below apply to both test designs. Read more