Sterility is defined as "freedom from all viable life forms."
Two broad groupings of pharmaceutical products are required to be sterile — parenteral and ophthalmic products. Such products must be free from all viable life forms, due to the potential consequential severity of the consequences of viable microorganisms present when the products are used in the manner intended or prescribed.
Confirmed incidents of nonsterility in supposedly sterile parenteral and ophthalmic products have been comparatively rare. However in the 1970-1971 Rocky Mount incident in the U.S., 40 deaths were attributed to nonsterile infusion fluids contaminated by Enterobacter cloacae, Enterobaccter agglomerans and other Enterobacter spp. (Felts et al., 1972; Maki et al., 1976). In the 1971-1972 Devonport incident in the U.K., five deaths of postoperative patients were attributed to nonsterile dextrose infusions contaminated by Klebsiella aerogenes (Clothier Report, 1972).
In the 1972-1973 Chattanooga incident in the U.S., three deaths were attributed to Enterobacter cloacae, Enterobacter agglomerans and Citrobacter freundii (CDC, 1973). In each incident there were many more nonfatal bacterial septicaemias. More recently there were 46 cases of bacterial septicaemia in Spain attributed to a nonsterile Burkholderia (Pseudomonas) pickettii contaminated aseptically filled ranitidine injection (Fernandez et al., 1996).
In 1964, eight patients in Sweden developed postoperative eye infections caused by Pseudomonas aeruginosa-contaminated eye ointment — one of the victims was left blind (Kallings et al., 1966).
More recently, in November 2002, the FDA issued a nationwide alert on all injectable drugs prepared by Urgent Care Pharmacy in South Carolina, based on lack of assurance that their products were sterile. A 77-year-old woman died and two other patients contracted an extremely rare fungal meningitis after receiving spinal injections of methylprednisolone prepared by Urgent Care. Spinal fluid from the patients tested positive for a rare fungus consistent with that found in the Urgent Care product.
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