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AQU@Sense MB - Instant results you can trust

AQU@Sense MB - Instant results you can trust

AQU@Sense MB - Instant results you can trust

Product catalog summary
Introduction
The document discusses the future of microbiological monitoring, emphasizing the need for rapid and accurate methods to assess the microbiological quality of water used in pharmaceutical processes. Traditional methods, such as colony-forming units (CFU), are criticized for being slow and imprecise.

Specifications and Procedures
The document highlights the limitations of CFU as a standard for measuring microbiological quality, noting that it is an estimate rather than a precise quantification. It advocates for the use of Rapid Microbiological Methods (RMM), such as flow cytometry, which provides results in less than an hour and allows for immediate action if microbial deviations occur.

Norms and Recommendations
Pharmacopoeias like the European Pharmacopeia (Ph. Eur.) and the United States Pharmacopeia (USP) support the implementation of alternative methods. They emphasize the importance of understanding the strengths and weaknesses of CFU and the need for a risk-benefit assessment when validating RMM.

Key Features of AQU@Sense MB
The AQU@Sense MB system offers several advantages, including quick and accurate bacterial identification, easy operation, and flexibility in integration. It can be used for both online monitoring and manual sampling, providing a total microbial cell count (TCC) and ensuring safer plant operations.

Validation and Implementation
The document outlines the validation process for RMM, which includes primary validation by the manufacturer and validation for intended use by the operator. It stresses the importance of a comprehensive validation process, including URS, DQ, IQ, OQ, and PQ.

Conclusion
The document concludes by encouraging the adoption of new technologies like AQU@Sense MB, which offer regulatory and technological advantages. It also highlights the user-friendly service plan provided by BWT, ensuring maximum uptime and reliability.
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Catalog excerpts

AQU@Sense MB - Instant results you can trust-1

Instant results you can trust

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AQU@Sense MB - Instant results you can trust-2

For all those who provide the best! FACT: » YOU CAN SAVE TIME OR WASTE TIME. » MANY PREFER SAFETY AS OPPOSED TO RISK. » THERE ARE VISIONARIES AND THOSE WHO KEEP ON DOING THE SAME THING. BUT WHICH OF THESE ARE YOU? It’s a waste of time if you have to wait five days to determine the microbiological quality of critical utilities, when you can obtain the results within an hour. You can increase safety and minimise risk by avoiding inaccurate measurements and increasing test frequency. Pharmacopoeias see the limits of traditional methods and the opportunities for implementing new processes in the future...

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Time for something new! been the standard for measuring the Colony-forming units (CFU) are still the for over 100 years. The regular determi- decisive factor in assessing microbiolo- nation with the plate-count method is gical quality, but even pharmacopoeias slow, expensive and error-prone. criticise the value of the data generated. The colony-forming units (CFU) have Pharmacopoeias therefore advocate the use and validation of alternative methods to determine microbiological quality. estimate rather than a precise quantification as, for example, only 0.1–1% of the By applying rapid microbiological...

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Expert monitoring FOCUS ON ONE ASPECT OR KEEP THE OVERVIEW The AQU@Sense MB has two operating modes. It can be permanently installed at a measuring point to automatically record the microbiological quality of critical utilities at regular intervals. Alternatively, manual grab samples from multiple sample points can be analysed by a single AQU@Sense MB. Action can be taken immediately, if your set limits are exceeded. Promptly. Not after five days, as before. FREEDOM TO CHOOSE The online use of RMM has many interesting features, one of which is the process control in systems that generate PW and...

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More cells are identified with RMM. This does not automatically indicate a higher risk or higher probability of pathogens. LIMITATIONS OF CFU We must understand the strengths and weaknesses of CFU as an indicator of microbiological quality. According to the USP, this knowledge is vitally important for a risk-benefit assessment and the validation of alternative procedures. Likewise, in accordance with Ph. Eur., it is essential to understand and define the objectives of the procedure when validating RMM. CLEAR VALUES The USP holds users responsible for proposing values to prove that the method selected...

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detection LASER SIMPLICITY AND SAFETY IN A BOX 1.000 measurements with no handling of chemicals. The practical, environmentally-friendly, reusable cartridge of the pioneering AQU@Sense MB also makes management and disposal a thing of a snap. The user can replace it on site in a matter of sample preparation minutes. The rest is managed by BWT. REUSABLE CARTRIDGE Integrated automatic sampling and processing saves time in the lab. The fully automated preparation of the sample includes dyeing, mixing and incubation. A laser induces cell fluorescence. A detector analyses the cells based on their fluorescent...

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Implementation & tests The use of alternative methods can be justified based on the Ph. Eur. The requirements are formulated precisely: the information must provide a scientifically sound benchmark for evaluating microbiological quality. Furthermore, the alternative method should not impose greater limitations than the conventional pharmacopoeial plate-count method. VALIDATION OF RAPID MICROBIOLOGICAL METHODS The validation process is described in Ph. Eur.. A distinction is made between the primary validation of the method performed by the manufacturer and the validation for the intended use by...

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USER-FRIENDLY SERVICE PLAN The AQU@Sense MB is designed to require no more than two scheduled services per annum, which is carried out by qualified BWT personnel as part of the fully documented AQU@Service. HIGHLIGHTS: » Maximum uptime: scheduled maintenance » Transparent, accurate maintenance and operating costs » Reliability due to verified accuracy Pioneers shape the future... The conventional method has disadvantages, but is There are many reasons from a regulatory and techno- accepted, while the accuracy and speed of alternative logical point of view to start testing and implementing methods...

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