ABSTRACT
Bacterial contamination of purified waters continues to present a challenge to
pharmaceutical, medical device, and cosmetics manufacturers. Biofilms are ubiquitous
other types of industrial water systems, and create similar health-related and economic
problems (Kulakov et al., 2002). The presence of bacteria and their associated endotoxins
(bacterial pyrogens) in pharmaceutical waters poses the single greatest threat to product
quality. Regulatory recalls directly related to bacterial bioburden are often associated
with contamination of purified water and water for injection; a review of the impact has
been published by Mittelman (Mittelman, 1995).
