Application note: Application of flow cytometry for microbiological monitoring of pharmaceutical grade water
As the main excipient for the pharmaceutical industry, water is integral to patient safety and the quality of pharmaceutical products.
Colony-forming units (CFU) are defined in the pharmacopoeias as the unit for assessing microbiological quality. CFUs are quantified using the traditional heterotrophic plate count (HPC) method; a five-day process with clear limitations for production timelines. Rapid microbiological methods (RMM) assess microbiological quality faster and, in some cases, continuously. RMM have been in use for more than three decades in other fields; however, they are considered up-and-comers in the pharmaceutical industry and companies are catching on to the added value of continuous contamination control.2