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METTLER TOLEDO Launches New On-Line Bioburden Analyzer
The RMS8120i is an on-line bioburden analyzer for microbial enumeration in pharmaceutical and other high-purity waters. The analyzer’s detection method continuously counts every microorganism in the sample, providing real-time analysis of water quality.
Billerica, USA – METTLER TOLEDO Thornton announces the launch of its RMS8120i on-line, real-time microbial analyzer.
For many years, measuring bioburden in Purified Water, Water for Injection, and Ultrapure Water has depended solely on labor-intensive, time-consuming, and error-prone culture-based lab measurements. First-generation on-line analyzers aimed to enable continuous monitoring but struggled with reliability. The new analyzer overcomes this hurdle, providing the continuous, uninterrupted performance necessary to ensure system integrity. The METTLER TOLEDO Thornton RMS8120i brings this capability to plant operations by continuously monitoring contamination in a flowing side stream. It uses patented BioSure™ laser-induced fluorescence (LIF) technology to provide accurate, real-time measurements of bioburden, including hard-to-detect viable but non-culturable (VBNC) microorganisms. This enables rapid water system control if an unexpected change in contamination is detected.
Primary validation of the RMS8120i analyzer has been completed following EP, USP, and PDA TR33 guidelines, helping to fast-track compliance in process monitoring programs. Additionally, with the extensive validation package, users can potentially reduce or eliminate the need for plate counting in certain settings.
When integrated with conventional plate count techniques, the RMS8120i offers a thorough approach to microbial contamination control for water quality assurance. The analyzer features a multi-parameter transmitter that streamlines monitoring of all chemical compendial water measurements.
“There’s been a growing interest for more than 10 years in rapid microbial methods because of their speed, efficiency, and accuracy of microbial detection. And also, because they support the FDA’s PAT framework due to their potential to greatly reduce costs of microbial testing,” says Anthony Bevilacqua, Principal Scientist at METTLER TOLEDO Thornton. “But they’ve gained attention mostly because of the risk of mitigation that they afford the water system owner. Getting microbial data in real-time, not five days later, reduces the risk of delivering contaminated product and reduces in-house hidden costs like investigations and quarantine delays. With the RMS8120i, we offer a unique and reliable solution that will reassure pharmaceutical companies that bioburden is under control and warn them instantly if it’s not.”
For more information on the RMS8120i microbial analyzer please contact: Arundhati.Samantha@mt.com, or visit www.mt.com/RMS8120i
