ABSTRACT
The use of compendial standards for the regulation of the identity, purity, potency, quality, packaging, labeling, and storage of parenteral drugs is familiar. Among the attributes that contribute to the quality of a sterile product is, obviously, documented evidence of its sterility. To this end, the sterility testing procedure is highly regulated. Sterility testing was first documented in the British Pharmacopoeia in 1932. The United States Pharmacopeia (USP) added sterility testing in 1936, and the methods described then remain largely unchanged (d’Arbeloff 1988).
