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Open the catalog to page 1For 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...
Open the catalog to page 2Time 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...
Open the catalog to page 3Expert 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...
Open the catalog to page 4More 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...
Open the catalog to page 5detection 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...
Open the catalog to page 6Implementation & 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...
Open the catalog to page 7USER-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...
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