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Reinigungsvalidierung Bestimmung der Sichtbarkeitsgrenzen von pharmazeutischen Feststoffen auf Edelstahloberflächen

Frank Buscalferri a , Dr. Sabine Lorenzen b , Dr. Michael Schmidt c , Dr. Hans-Martin Schwarm d , Dr. Ehrhard Anhalt e , Dr. Reinhard Herzog a und Prof. Ronald Ziegler a

Fachhochschule Albstadt-Sigmaringen, Fachbereich Pharmatechnik, Sigmaringen a , Queisser Pharma GmbH & Co., Flensburg b , G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt c , STADA Arzneimittel AG, Bad Vilbel d , und Bundesfachverband der Arzneimittel-Hersteller (BAH), Bonn e

For cleaning validation usually the strongest limit is used. In order to evaluate the visually clean (VC) criterion it becomes necessary to know the amount of product, which remains on the surface of the equipment after cleaning procedure. Up to now only one publication was available indicating 387,5 µg solid substance/100 cm² surface as visibility limit. A further experimental investigation now confirms this value. Thus, the VC-criterion often may serve as acceptance criterion.