These Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has beensterilized. This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures.The test is applied to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile.However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined under theconditions of the test.