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The need for on-line microbial monitoring is becoming more apparent in the pharmaceutical industry, as it can offer companies immediate feedback and transparency on events or excursions, compared to traditional plate counting. Conductivity and total organic carbon are two process analytical parameters where on-line measurements are widely used and accepted. The pharmaceutical industry, the pharmacopeias, and regulators acknowledge, recognize, and endorse the need to monitor bioburden in real time. The ability to monitor microbial contamination on-line offers significant advantages in process control.
A leading biotechnology company integrated a 7000RMS analyzer from METTLER TOLEDO for on-line microbial monitoring as a process control tool on its PW system. The customer defined a baseline measurement and could see their water system was steady and under control, then measurements started fluctuating.
Find out in the case study why fluctuations were observed and what it meant for the company and its production.
The METTLER TOLEDO 7000RMS analyzer detects microbial presence within seconds of a sample entering the analyzer. Measurements are continuously updated, providing a real-time profile of PW or WFI systems. Real-time monitoring eliminates waiting periods for results and trending data enables the ability to react prior to an out-of-specification event.
Continuous monitoring with results every two seconds allows optimization of sanitization frequency and rinse time. On-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 under control.
The 7000RMS uses two well-established optical measurement techniques in combination to provide real-time data and process transparency into a pharmaceutical facility's water system. The analyzer’s highly sensitive technology can count individual microorganisms down to 0.3 μm in size, allowing significantly better control of water quality.
