ABSTRACT
Parenteral Pharmaceuticals are sterile products analyzed for the absence of bacteria, yeast, and mold. Standard microbiological procedures for detecting and identifying microbial contamination rely on the cultivation and isolation of microorganisms from pharmaceutical samples (1, 2). Because parenteral Pharmaceuticals are manufactured under stringent aseptic conditions, to guarantee the absence of microorganisms from the production facility and finished product, several microbiological procedures are performed. Environmental monitoring of production facilities requires the sampling of analysts, water, air, and surfaces, and finished product testing using compendial methods is performed on production and in-process samples (3-5). Although standard methods are routinely used for quality control analysis, they require long incubation times, continuous manipulation, and time-consuming procedures (6). Furthermore, it has been recently reported that standard methods underestimate the microbial communities present in pharmaceutical environments (7-9). This is because standard methods were developed for isolating and detecting microorganisms from clinical samples. Microorganisms living under high organic carbon habitats such as clinical samples respond to those conditions with totally different metabolic and survival strategies. However, when confronted with low organic carbon and other environmental fluctuations (e.g., changes in temperature, pH, pressure, presence of antimicrobial ingredients), microorganisms exhibit several survival strategies that will make detection and identification by standard methods more complicated (4, 8, 10, 11).
