Enhancing Microbial Monitoring

With interest growing in on-line microbial monitoring, Stilmas, a company specialized in the design, development, and construction of storage and distribution systems for pharmaceutical waters, collaborated with METTLER TOLEDO to assess our 7000RMS(TM) bioburden analyzer.

One of the objectives was to evaluate the quality of data from the analyzer as a process control measurement of microorganisms in routine water system operation. In addition, the 7000RMS was assessed to determine the efficiency and effectiveness of sanitization performed on the water system to maintain microbial control.

This case study looks at the results of Stilmas' testing of the 7000RMS and considers the analyzer's efficiency in microbial monitoring for the control of a pharmaceutical water system.

The compendial test for microbial monitoring and control of a water system predominantly relies on the traditional plate-count method. This method not only requires a long time to obtain results, it may also introduce contamination to samples, possibly resulting in false-positive tests.

The 7000RMS bioburden analyzer is an at-line instrument that provides real-time and continuous microbial monitoring of a water system, without sample preparation or incubation. The units generated by the 7000RMS, auto-fluorescent units (AFUs), are a measurement of the microbial cells in a water system. As a sample of the water flows through the 7000RMS, it is exposed to a 405 nm wavelength laser. Metabolites, such as NaDH and riboflavin, on the membrane of any cells in the water emit fluorescence in response to the laser light. The analyzer detects the fluorescence and counts how many cells are present. This approach eliminates the variability and time-consuming nature of traditional plate counting. Real-time microbial monitoring allows water release without having to wait for plate-count results.