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ScanRDI®: the ultra sensible and ultra fast analyzer for microbiological control of pharmaceutical products
ScanRDI®: the ultra sensible and ultra fast analyzer for microbiological control of pharmaceutical products
Ten years ago innovative methods appeared as an alternative in microbiological control in the pharmaceutical industry. The idea was appealing, to control the environment in real-time, reduce the time of product release, evaluate sterility tests the same day, and to validate the bioburden or the process water in less than 2 hours… Since then the regulations have been evolving amidst the pharmacopoeias as well as the acknowledgement of the professionals. Now, not only the tools are available, but also, they are used more and more on a routine basis. AES CHEMUNEX is the best example thereof, through the success achieved with the ScanRDI, which has developed to be today a method of reference in fast microbiology for the sterile pharmaceutical industry. The approach taken by AES CHEMUNEX, in accordance with the Pharmacopoeia (USP, EP) is in fact, the only direct and quantitative method available on the market. The principle of the direct marking of the microorganisms with epifluorescence is today well accepted and recognized, and has demonstrated excellent results in the past years. Together with the laser scan of the ScanRDI the method allows also to obtain the result in less than 2 hours, and is directly comparable with the reference method. The major pharmaceutical companies cannot be wrong when having opted for this method, when having obtained numerous FDA approvals and enormous financial savings! It is therefore very difficult not to count with AES CHEMUNEX in this field, especially since the group offers a complete range of flow-cytometers for products not necessarily sterile and marketed with the trade names of D-Count, BactiFlow and BactiFlow ALS.

(01/04/2009)
Mark NTL108-15




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