A single product recall can cost $1M, and investigations $10K+. Catch microbial contamination before it becomes a problem.
Real-time visibility of bioburden levels eliminates the uncertainty of releasing at-risk water.
Continuous data enables risk-based assessment of cleaning frequency and sanitization duration.
The RMS8120i instantly detects microbial changes in water systems, allowing fast response to contamination and optimized sanitization cycles.
Continuous, real-time monitoring eliminates the uncertainty of releasing at-risk water.
Primary validation test completed according to EP, USP, and PDA TR33 guidance for faster analyzer integration into water systems.
Robust design and BioSure LIF technology provides stable and repeatable measurements in a completely automated detection system.
The RMS8120i real-time microbial analyzer combines two well-established measurement technologies, laser-induced fluorescence and Mie scattering. The analyzer counts individual microorganisms present in pharmaceutical water. Without collecting a sample or waiting days for plate count results, the RMS8120i delivers real-time monitoring of bioburden contamination.
Watch the video to see how it works!
Providing continuous results in seconds, this real-time microbial analyzer requires no sample preparation or incubation period, eliminating delays in product release.
The RMS8120i Microbial Analyzer automates microbial monitoring, eliminating the variability and delays of traditional plate-counting methods while enabling faster verification of water quality.
Combining two well-established measurement technologies, the bioburden analyzer uses laser-induced fluorescence and Mie scattering to count microorganisms in pharmaceutical grade water systems.
With the ability to monitor water system trends prior to an out-of-specification event, the real-time microbial analyzer helps to identify the root cause of contamination events.
Rapid microbial monitoring with the RMS8120i online water bioburden analyzer gives you full visibility of changes in contamination levels to reduce risk and ensure water quality for release.
The RMS8120i Microbial Analyzer provides microbial detection of organisms down to 0.3 microns, and the technology does not rely on the formation of colonies like traditional plate counting methods.
Use continuous trending data from the rapid microbial method to establish a baseline and detect shifts before and after sanitization, helping determine the optimal sanitization frequency and assess its effectiveness.
Explore the regulatory view on rapid microbial detection methods. Learn key validation guidelines and adoption strategies for pharmaceutical water.
The METTLER TOLEDO Thornton RMS8120i (Real-Time Microbial Analyzer) is suitable for monitoring microbial contamination in pharmaceutical and other high-purity water systems, including Purified Water (PW), Water for Injection (WFI), and Ultrapure Water (UPW), by continuously detecting and enumerating microorganisms in real time using laser-induced fluorescence (LIF) technology.
The RMS8120i™ combines two well-established measurement techniques, laser-induced fluorescence and Mie scattering, to count individual microorganisms present in pharmaceutical grade waters. The RMS8120i delivers continuous, 24/7 monitoring of bioburden contamination without collecting a sample or waiting days for plate count results.
Culture-based lab measurements of microbes can create challenges. Microbial monitoring in Purified Water, Ultrapure Water and Water for Injection has almost exclusively depended on time-consuming and error-prone culture-based lab measurements.
Fornecemos suporte e assistência técnica durante todo o ciclo de vida de seu equipamento de medição, da instalação à manutenção preventiva e da calibração ao reparo do equipamento.
An Auto Fluorescent Unit (AFU) is the unit of measurement used by the RMS8120i to identify the number of active viable and non-viable single microorganism units in a water sample that have been detected, quantified, and meet specific photonic parameters that are known and associated with microorganisms.
A Colony-Forming Unit (CFU) is the unit of measurement used to count and estimate the number of viable cells in a sample. To determine a CFU count, bacteria are cultured on media plates and induced to form colonies that can be individually counted. A colony may originate from one microorganism or from multiple microorganisms growing together, so CFU is an estimate rather than an actual count of individual cells. [PB1] An AFU is an actual count of a single microorganism, as opposed to an estimation based on colony growth.
A colony may originate from one microorganism or from multiple microorganisms growing together, so CFU is an estimate rather than an actual count of individual cells.
There are numerous ways to measure microbial contamination of water, and USP recommends specific ways for pharmaceutical waters.
Traditionally, plate count methods are widely used for releasing water; however, they are prone to error and can take 5-7 days to obtain results. Plate counting also requires the formation of a colony of bacteria on a plate, and hence, the measurement unit is called the 'colony forming unit' or CFU, which estimates the total number of bacteria present in the sample plate.
Another way of measuring microbial contamination in water is through laser-induced fluorescence with a microbial detection analyzer. These analyzers use laser-induced fluorescent technology to measure the total number of cells that are present in the sample volume of water. Systems that use this technology allow at-line, real-time monitoring of microbial contamination in pharmaceutical waters by identifying cells present in the sample water immediately and are reported as auto-fluorescent units (AFUs).
It depends on the water system, usage, and maintenance. RMS8120i detects viable cells as well as nonviable (VBNC) cells. AFU counts are, in most cases, more than the CFU counts. The industry knows that there is no direct and universal correlation between AFU and CFU, as AFU includes every single microorganism, and CFU is only the organism that forms a colony on the plate, provided it gets all the required optimal circumstances. (Refer to USP <1223>). The user can use the analyzer to set a baseline AFU for their specific location.
Also, in the regulatory guidelines, there are no pass/fail numbers for the AFU, as AFUs are every single microorganism in the water system, and they are not homogeneously distributed, as are chemicals like salt and others. The analyzer can be used for process control and gathering better understanding of your water system by monitoring the AFU trend.
The Microbial Analyzer RMS8120i is a real-time monitoring system designed to detect and quantify microbial contamination. When used in parallel with plate counting, this bioburden analyzer offers a rapid microbial method (RMM) solution for better microbial control of your water system, reducing the risk of releasing contaminated water and improving process control.
The bioburden analyzer uses laser-induced fluorescence and Mie scattering to monitor results continuously every two seconds. This can improve process transparency and help significantly reduce costs.
The RMS8120i Microbial Analyzer is an Online Water Bioburden Analyzer; it is intended for use in Ultrapure Water (UPW), Water for Injection (WFI), and Pure Water (PW) applications.
The RMS8120i is optically configured and optimized for PW, UPW, and WFI, and cannot be used to evaluate the microbial risk of a finished product. Any additive including salt, sugar, colors or any other common ingredient can damage the fluidics of the analyzer and therefore are not allowed inside the analyzer.
The RMS8120i is designed to be used as a continuously running process control tool for pharmaceutical-grade waters, which are the raw ingredient for most pharmaceutical products. It can test PW, UPW, and WFI from main water loops, sub loops, and other common locations in the loop.
The analyzer uses laser light to detect particles. When a particle in the flowing water sample passes through the flow cell and is illuminated by the laser beam, it scatters light (a principle called Mie scattering), which is measured to confirm its presence. In addition to scattering light, microbial cells contain naturally fluorescent metabolites such as NADH and riboflavin. The analyzer detects the fluorescence emitted by these compounds.[PB1] A particle is counted as an AFU only if both light scattering and fluorescence are detected simultaneously from a single source.
In addition to scattering light, microbial cells contain naturally fluorescent metabolites such as NADH and riboflavin. The analyzer detects the fluorescence emitted by these compounds.
The RMS8120i can detect microorganisms that are ≥ 0.3 μm in size. This includes common bacteria and fungi/yeasts known to be found in pharmaceutical-grade water systems, such as:
The RMS8120i detects both viable and non-viable cells because both can fluoresce as long as the cell wall is intact, and the metabolites (NADH and riboflavin) are undamaged. Therefore, it will detect the presence of cells in the water sample, regardless of whether they are viable (able to grow) or non-viable (unable to grow). The RMS8120i cannot distinguish viable from non-viable cells based solely on fluorescence. A key advantage of the technology is its ability to detect viable but non-culturable (VBNC) bacteria, which are often missed by traditional plate-count methods.
Yes, the RMS8120i will detect cells at each of the bacterial growth phases. This is advantageous over traditional plate methods, which only quantify bacteria in the exponential growth or stationary phases. The RMS8120i will detect bacteria from the lag phase through to the death phase.
The RMS8120i cannot identify species of organisms present in water. It is a direct cell detection technology for real-time monitoring of pure waters. The user is responsible for identifying and speciating the exact organism present.
The RMS8120i bioburden analyzer provides microbial detection of organisms down to 0.3 microns. The technology does not rely on the formation of colonies like traditional plate counting methods.
The RMS8120i’s measurement range is 0-10,000 total AFU counts/mL.
The RMS8120i analyzes 1 mL of sample every ~4.4 seconds.
The user can customize the result display interval time as per their requirement in terms of seconds or in minutes depending on volume interval.
The user has the flexibility to display results as per any volume desired. For example, results for every 1 mL or 100 mL of sample may be displayed. In this way, the results may coincide with USP specified volumes for PW or WFI samples.
When used in conjunction with plate counting, this online water bioburden analyzer provides a rapid microbial method (RMM) solution. It is designed to enhance your process control by regularly giving you a comprehensive understanding of your entire water loop. This will improve process transparency, enabling you to act promptly in case of an excursion event.
Furthermore, the analysis time is continuous, and the analyzer provides results every two seconds, requiring no sample preparation or incubation period.
The RMS8120i specifications require that particles entering the unit be less than 50 μm in size. The unit comes with a 15-micron filter on the inlet.
Yes. The maximum temperature allowed for the RMS8120i is 90°C. RMS8120i can analyze water from 5 - 45°C (non-condensing) without a conditioning coil and water from 45 - 90°C (non-condensing) with a conditioning coil.
Minimum 5 PSIG or 0.34 bar(g)
Maximum 100 PSIG or 6.89 bar(g)
The RMS8120i requires 1/8” OD (or 6 mm ID with 3.2 mm OD) tubing rated for a minimum of 125 PSIG. Compression fittings are used to secure the tubing in permanent installation.
Typical materials include stainless steel and PFA.
An atmospheric drain is also required. Process connections should be made in accordance with local mechanical standards and should employ a minimal amount of threaded connectors and dead volume spaces within fittings. Ensure that the online connection to the process steam has thoroughly been blown down (rinsed flowing directly to drain) before making the connection to the Online Input port of the RMS8120i.
If sample flow is stopped, the RMS8120i will not shut down, but it will turn off measurements. Once sample flow resumes, measurements will resume.
We recommend that the RMS8120i be calibrated every 12 months.
The calibration procedure comprises both the flow rate and the detection system. The detection system is calibrated using the Solutions Kit, available from METTLER TOLEDO. The calibration procedure requires approximately 3 hours to perform.
Maintenance of the RMS8120i includes Basic Preventive Maintenance and Full Preventive Maintenance procedures at a frequency of 1 year and 3 years respectively. In terms of general cleaning, please refer to cleaning and sanitizing documents.
No NIST-traceable online Rapid Microbial Monitoring (RMM) device-specific beads have been defined yet. The calibration solutions for the RMS8120i are made of fluorescent beads that mimic microorganisms as closely as possible. These beads are used in two different concentrations to qualify the instrument, calibrate, and verify the measurement.
We recommend that the RMS8120i be calibrated at a frequency of every 12 months.
Laser replacement is performed during Full Preventive Maintenance every 3 years. During the annual maintenance process, the METTLER TOLEDO Service technician monitors the laser hours and performance to make suggestions at the ideal time.
The Intelligent Sensor Management (ISM) menu also keeps count of the hours of laser operation.
Water systems vary and, therefore, may require customized approaches to cleaning cycles depending on the microbial and particulate load.
It is NOT possible to use formulated agents, such as Steris Spror-Klenz or other chemicals as they can damage some of the fluidic components inside the unit.
Do not use alcohol or bleach inside the analyzer’s fluidics, as they may damage some fluidic components.
It is preferable to run a clean cycle between organism species when subjecting the instrument to bacterial testing.
For more information, please refer to the manuals and other available documents.
For optimal functioning of the RMS8120i, the user needs to provide an ideal non-condensing environment and water flow as specified in the datasheet. Maintenance will be performed by METTLER TOLEDO Service personnel at the time of calibration and during basic preventive maintenance.
METTLER TOLEDO offers an IQ/OQ/PQ service called Comprehensive Qualification. Commissioning of the RMS8120i online microbial analyzer consists of installation verification, operational verification, and calibration. The METTLER TOLEDO Service technician performs this procedure at the customer site to fully qualify and commission the RMS8120i analyzer after installation.
The recommended transmitter for the RMS8120i, the M800, supports Ethernet/IP since that also enables RecordLOC functionality. However, when paired with an appropriately equipped M800 transmitter, the RMS8120i will communicate with industrial systems using Profinet or ProfibusDP. Ethernet/IP, Profinet, and ProfibusDP platforms enable full ISM functionality. All M800s can also assign the RMS8120i measurement values as analog outputs or transmit them as plain ASCII text over the RS-485 datalog/printer interface. This limits transmissible ISM information to lifetime indicators and only such auxiliary parameters that can be scaled as analog outputs.