ABSTRACT
Microbial testing performed in support of pharmaceutical and biopharmaceutical production falls into three main categories: detection (qualitative), enumeration (quantitative), and characterization/identication. Traditional microbiological methods listed in the compendia and discussed in various chapters of this book use conventional growth-based techniques, which are labor intensive and time consuming. In general, such tests require days of incubation for microbial contamination to be detected, and therefore management seldom is able to take proactive corrective measures. In addition, microbial growth is limited by the growth medium used and incubation conditions, thus impacting testing sensitivity, accuracy, and reproducibility.
