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Which Is Best For Pharmaceutical Water Systems: Sanitization, Disinfection, Or Sterilization?
By Marc W. Mittelman
Regulatory recalls directly related to microbial bioburden are often associated with contamination of USP (United States Pharmacopeia) Purified Water and USP Water for Injection. Several reviews of the impact have been published (1, 2). Growth of bacteria and the associated generation of endotoxins in pharmaceutical-grade Purified Waters accounts for a significant number of regulatory actions by the U.S. Food and Drug Administration (FDA) and other international regulatory bodies.
Jimenez (3) analyzed FDA recalls for 134 non-sterile pharmaceutical products from 1998-2006. The majority of the recalls were associated with Burkholderia cepacia, Pseudomonas spp., or Ralstonia pickettii, all of which are common isolates for pharmaceutical-grade Purified Water systems. B. cepacia was the most frequently isolated bacterium associated with recalls of sterile products; again, this organism is commonly recovered for compendial waters. Methylobacterium spp. are also commonly recovered from pharmaceutical-grade and other types of high-purity waters (4).
The vast majority of bacteria isolated from pharmaceutical-grade (or compendial) Purified Water systems are gram-negative, non-fermentative bacilli. Similarly diverse populations are often found in potable waters and other treated and untreated water systems. The gram-negative cell wall consists of multiple layers of phospholipids surrounded by a lipopolysaccharide (LPS) structure. This multilaminate structure may afford the cell protection from the extremely hypotonic environment that is intrinsic to Purified Water systems. These bacteria are heterotrophic, requiring the presence of reduced organic compounds as energy sources.
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