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In pharmaceutical waters, improved process understanding can mitigate lengthy contamination investigations. This is demonstrated in this case study by explaining the use of on-line microbial analyzers to understand the cause of periodic high plate counts in a purified water loop.
Risk management has become a critical discussion point for pharmaceutical companies globally. The risks faced, especially in terms of product quality and commercial practices, are increasing in frequency and magnitude.
Real-time bioburden data on a pharmaceutical water system can deliver multiple advantages. In order to provide a demonstraton of this, a study was conducted using continuous microbial detection analyzers in a purified water loop. The data from the continuously operating 7000RMS analyzers was examined to see if the cause of periodic high plate counts could be ascertained.
METTLER TOLEDO's 7000RMS Microbial Detection Analyzer uses advanced laser-induced fluorescence and Mie scattering technologies to provide immediate detection and quantification of microorganisms. It provides real-time information on microbial content in the water sample. The analyzer allows for quick response to events in the water loop to reduce time spent on investigation, and the trend analysis captures gradual changes in water quality that can lead to contamination events.
