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Microbial testing in pharmaceutical waters has traditionally relied on laboratory-based test methods. However, these methods are labor-intensive, subject to false results, provide only a snapshot of water quality, and may take 5-7 days or longer to generate measurements. This means that if the water is out of specification, it is being used for many days in manufacturing before the test results are available.
This case study looks at the use of an on-line microbial contamination analyzer, METTLER TOLEDO’s 7000RMS, as a tool for microbial testing in real-time at a pharmaceutical manufacturing site.
The 7000RMS detects and enumerates microorganisms as Auto Fluorescent Units per unit volume and measures viable but not culturable microorganisms, providing a far more accurate and complete picture of bioburden contamination and contamination trends due to regular system operation. Real-time monitoring eliminates waiting periods for test results, minimizing risk and reducing costs.
An alarm was triggered on the ambient WFI parameters during a routine facility walkthrough at a US pharmaceutical manufacturing site. An elevation in the reading from the 7000RMS at the return location of the ambient WFI distribution system, triggering the alert limit. The increase in the reading prompted the facilities and QC microbiology teams to start an investigation to assess the risk to the water quality and identify the root cause of the event.
.png/_jcr_content/renditions/cq5dam.web.1280.1280.png "Ledningsevnesensor/modstandsevnesensor")
.png/_jcr_content/renditions/cq5dam.web.1280.1280.png "Transmittere")