AQU@Sense MB
Immediately more insight through real process control. Continuously monitor the microbiological quality of pure water.
- RMM by means of precise flow cytometry,
- Determination of live cell count in 20 minutes
- Primary validation
- Automated continuous at-line or off-line measurement
The future of monitoring microbiology. Available now.
Why waste time and wait 5 days to assess the microbiological quality of Purified Water when you can respond within an hour? Enhance safety and mitigate risks by avoiding inaccurate measurements and increasing testing frequency.
Recognize the risk of pathogen growth earlier. Start sanitization in line with requirements. Prove their efficiency instantly afterwards.
It is now the time for more accurate and faster processes to determine bacteria levels in water. BWT recommends flow cytometry.
5 great reasons for AQU@Sense MB
1. MEASUREMENT
Reliable and accurate counting of all cells, not just colonies
2. OPERATION
It is simple, intuitive, and user-friendly
3. CONNECTIVITY
Simple data transfer for system integration into SPS
4. FLEXIBILITY
Integration in the ultra-pure media system or manual sampling
5. SPEED
Results and reaction if required in < 1 hour
Sample
Integrated, automatic sampling and processing ease the load on the laboratory.
Preparation
Fully automatic preparation of samples covers dyeing, mixing and incubation
Visualization
The HMI provides information and values. Data exporting is simple too.
Cartridge
The closed cartridge collects the used sample and also contains the necessary liquids for ~ 1,000 measurements.
Analysis
The results are available after 20 minutes. The total cell count (TCC) as well as the size can be seen based on the nucleic acid contained.
Cleaning
The cleaning process is carried out automatically. The AQU@Sense MB is ready for the next sample
Measurement
A laser makes the cells glow. A lens records and measures the cells. Counting is as accurate as with a laboratory unit
Downloads
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AQU@Sense MB - deutsch | PDF, 2 Mb | Download |
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AQU@ Service - Critical Utilities in the best hands | PDF, 3 Mb | Download |
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EPR: Flow cytometry for microbiological monitoring of pharmaceutical grade water (EN) | PDF, 1485 Kb | Download |
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PDF, 3 Mb | Download |
Important to know. Facts from the USP regarding CFU & RMM
About CFU as the ultimate benchmark
CFU remains the key variable in assessing microbiological quality. However, even the pharmacopeia criticize the validity of this method.
The USP considers the CFU value to be more of an estimate than an exact figure as, for example, only 0.1–1% of all germs are counted as CFU in potable water. As a result, it is posited that CFU should not be considered the only measure for assessing microbiological quality.
According to Ph. Eur., the applicable threshold values were established without quantitative measurement. As an example, the—randomly—determined acceptable value of 10 CFU / 100 mL for WFI has become the norm.
It can be seen: even the pharmacopeia clearly see the weaknesses and limits of conventional methods of measuring CFU. For this reason, it is now time to use cutting-edge technologies that can offer game-changing advantages to quality managers and microbiologists.
Limitations of CFU
It is necessary to understand the strengths and weaknesses of CFU as an indicator for evaluating microbiological quality. According to USP, this knowledge is of paramount importance for the risk assessment and also for validating alternative processes. According to Ph. Eur., understanding and defining intentions with the process are also essential for validation using RMM.
Precision of the processes
More cells are recognized with RMM. However, that does not automatically mean an enhanced risk or an increased probability of pathogens.
Comparison of values
Microbiological quality is determined indirectly and with various processes, which is why the values are different (such as CFU & ICC).
Similarity of values
Values from conventional and alternative processes do not have to correspond with each other. Clear values and judgement are important.
Clear values
The USP states the user is responsible. They must suggest values where evidence succeeds in demonstrating that the chosen method is suitable for assessing microbiological quality. This can happen regardless of existing standards, expressed as CFU. As a result, other microbiologically valid measurements are also permitted.
Judgement
Regardless of the process, according to USP, the following are important: Microbiologists must be able to make the same decision at any time regarding product quality. That is regardless of whether this is based on CFU in line with the plate technique or the cell number from RMM.
Current expectations
The pharmacopeia do not claim a correlation between RMM and KBW. Incorrect, unrealistic expectations regarding the equality of values makes implementation of new processes more difficult.
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