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In the context of drug production, airborne contamination control is a crucial step to insure good quality products. A lot of norms and recommendations have been written for international or European standards such as FDA, AFSSAPS, ISO...
Most of the last texts and recommendations encourage the implementation of Rapid Microbiological Methods (RMM) in order to get better and faster results; one of the main goal is to get rid of the long time to results linked to the incubation step necessary with the traditional method (based on cultivability).
Process monitoring in aseptic conditioning zones can be ensured by the Coriolis® µ and also laminar flow hood and isolator controls. Grades A, B, C and D can be monitored with the Coriolis µ air sampler.
It can also be used for decontamination procedure evaluation and will allow the production to start much earlier than with traditional microbiology methods (incubation during several days).
Last but not least this system is a good tool for investigation step : thanks to its liquid sample, rapid results can be performed and thus rapid corrective actions once the source cause and location have been determined; it allows to minimize the time the process need to be stopped because of suspicious contamination See our references in Pharma Industry See our application forms and publications related to cleanrooms and RMM’s
See our application forms and publications related to pharmaceutical industries
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