ABSTRACT
Water is a major pharmaceutical ingredient and has been identified as a significant potential source of microbial contamination. This view is supported by the prevalence of pseudomonads in nonsterile pharmaceutical drug product recalls. For example, for the 10-year period of 1991-2001, the average number of recalls per annum for microbial contamination of nonsterile pharmaceutical and over-the-counter drug products was six recalls. The emphasis on water-borne gram-negative bacteria of the species Burkholderia (Pseudomonas) cepacia (10 recalls), Pseudomonas putida (5 recalls), Pseudomonas aeruginosa (4 recalls), Pseudomonas spp. (2 recalls), Ralstonia (Pseudomonas) pickettii (1 recall), Pseudomonas alcaligenes (1 recall), and Pseudomonas baleurica (1 recall) is notable. Pseudomonads represent 40% of the recalls and this reflects the Food andDrugAdministration (FDA) concern for bacteria derived from water, which are capable of growth in liquid oral dosage forms and of overwhelming the preservative system.
