Real-Time Bioburden Monitoring in Pharmaceutical Water with 7000RMS

This video discusses microbial contamination risks and a complementary test method that can be used in a parallel with plate counting to avoid an out-of-spec event, water system quarantine or product recall. It highlights the 7000RMS microbial detection analyzer for online water bioburden analysis (OWBA) as a solution to help mitigate the risks of contamination to pharmaceutical grade waters.

Pharmaceutical bulk waters are used throughout the production of drugs and medical devices. Thus, testing for microbial contamination is critical to meeting pharmaceutical regulations and avoiding costs and legal issues associated with a contamination event. Bioburden levels must be monitored and controlled below pharmacopeia limits to allow bulk waters to be released for use.

While plate counting is a regulatory requirement and commonly used test method, there are still inherent risks and delays that can cause you to miss a bioburden excursion even though you perform routine sampling.

These risks include microbial contamination due to:
• sampling and testing errors that can occur no matter how careful the lab technician is during the various stages of sampling
• using “at risk” water during the 5-7 day waiting period for plate count results
• infrequent sampling, often times sampling is based on convenience and available resources
• relying on variables such as growth media, incubation conditions, nutritional requirements to culture properly and yield accurate test results

What if there was a way to reduce these risks and never miss another bioburden excursion?

Instead of relying on traditional sampling methods to give you limited snapshots of your water quality, why not use a complementary test method to give you instant real-time data. Real-time bioburden analysis allows you to react quickly to any trend or excursion before it becomes an out-of-specification event. Continuous analysis provides full transparency to help you release water with confidence. The real-time data can also help you optimize sanitization frequency and rinse time for a significant time and cost savings as well as complete process control.

To learn more about reducing bioburden contamination, download the white paper, "Microbial Contamination Risks and Preventing Them with Real-time Analysis"
https://www.mt.com/us/en/home/library...


To request more information or pricing on the 7000RMS Real-time Microbial Detection Analyzer , visit:
https://www.mt.com/global/en/home/pro...

The METTLER TOLEDO 7000RMS Real-time Microbial Detection Analyzer combines two well-established measurement technologies, laser-induced fluorescence and Mie scattering, to count individual microorganisms present in pharmaceutical water. The 7000RMS delivers instant real-time monitoring of bioburden contamination without collecting a sample or waiting days for plate count results.

METTLER TOLEDO produces a full range of on-line measurement solutions for monitoring pharmaceutical water quality. To learn more about our solutions, download the pharmaceutical waters guide on regulatory compliance, analysis and real-time release:
https://www.mt.com/global/en/home/lib...

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