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There are many risks when it comes to microbial contamination of water in the pharmaceutical industry, including the possibility of having to scrap a production batch, or even product recalls. Therefore, pharmaceutical waters need to be monitored closely for contaminants. Testing the water for microbial contamination can be done by sampling and plate counting, but this method is culture-based, so not only is it time consuming, it is also prone to errors.
Regulatory committees have put an added emphasis on on-line measurements for “real-time process control, decision and interventions” (PAT [Process Analytical Technologies] Initiative by the FDA).
Rapid, real-time microbial detection is an emerging technology from METTLER TOLEDO that can be used in parallel with plate counting to ensure process control of pharmaceutical water systems by providing continuous quantification of microbial contamination with no waiting period.
This white paper details the problems associated with pharmaceutical water contamination and summarizes the potential impacts of contaminated water. It also provides insights and guidance on how to mitigate the risks of pharmaceutical water contamination by using METTLER TOLEDO Thornton’s 7000RMS microbial detection analyzer.
The METTLER TOLEDO 7000RMS analyzer uses two well-established optical measurement techniques in combination, to provide real-time data and process transparency into a pharmaceutical facility's water system. Using the 7000RMS at points-of-use, sub loops, or distribution loops will help you make informed decisions to ensure the required quality of the water is released to production.
The 7000RMS detects microbial presence within seconds after a sample enters the analyzer. Measurements are continuously updated, providing a real-time profile of PW or WFI systems. This simultaneous information enables you to quickly divert contaminated water before it impacts other locations within the water system.
Continuous monitoring with the 7000RMS enables a more accurate and constant surveillance of a system’s water quality. At-line monitoring enables early indication of microbial excursions so that process and quality groups can ensure water used for manufacturing is always in compliance and always in control.
