Blow/Fill/Seal— Such a technique brings together the blow-molding of container Using the filling of products in addition to a sealing operation in a single piece of equipment. From the microbiological viewpoint, the sequence of forming the container, filling with sterile merchandise, and formation and application in the seal are achieved aseptica… Read More


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If the above modification will not offer a limit of detection reduce compared to the acceptance conditions established, a whole new method to be made, that may attain the required lower detection concentration. In the event of modification, the method should be revalidated.This guideline complements the EMA’s strategy, delivering supplemental ins… Read More