ABSTRACT
All lots of injectables in their final containers must be tested for sterility, except for products that are allowed to apply parametric release. 2 The United States Pharmacopeia (USP) prescribes the requirements for this test for official injections. Portions of the USP sterility test chapter <71> have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. The FDA uses these requirements as a guide for testing official sterile products. The primary official test is performed by means of filtration, but direct transfer is used if membrane filtration is unsuitable. To give greater assurance that viable microorganisms will grow, if present, the USP requires that all lots of culture media be tested for their growthpromotion capabilities. However it must be recognized that the reliability of both test methods has the inherent limitations typical of microbial recovery tests. Therefore, it should be noted that this test is not intended as a thoroughly evaluative test for a product subjected to a sterilization method of unknown effectiveness. It is intended primarily as a check test on the probability that a previously validated sterilization procedure has been repeated or to give assurance of its continued effectiveness.
