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This case study describes how a pharmaceutical facility evaluated METTLER TOLEDO’s 7000RMS™ Microbial Detection Analyzer to gain more information on bioburden levels for improved process control and data-driven water system maintenance.
The traditional plate-count method of determining microbial contamination lacks sensitivity and accuracy in microbial detection and enumeration. And delays in obtaining results do not allow timely corrective actions when an out-of-specification event occurs.
The 7000RMS Analyzer provides the real-time data required to prevent contaminated water from reaching points of use and to assist in root cause analysis when an excursion occurs. Continuous measurements from the 7000RMS can be used to support a proactive maintenance strategy and additionally provide more value to process control than Colony Forming Units (CFU), which are only used for allowing the release of PW to production.
Facility engineers at the pharmaceutical company cannot make real-time, data-driven decisions for the maintenance of their PW system based on the compendial microbial method. Whereas, the continuous bioburden measurements from the 7000RMS allows the facility engineers to further their understanding of the water system’s status and progression.
Further, the continuous Auto Fluorescent Unit (AFU) measurements from the 7000RMS can be used as an informative tool to support a proactive maintenance strategy. The impacts of chemical and filter sanitization activities on a water system can be evaluated to optimize the overall process of the water system. The AFU results, accompanied by other analytical measurements, can support a data-driven water system maintenance strategy of the entire PW loop. Trending data enables the ability to react before an out-of-specification event occurs, reducing costs and minimizing risk.
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