Merz Pharmaceuticals is an innovative pharmaceutical company focussed on the research and marketing of pharmaceuticals for treating neurological and psychiatric illnesses. The site in Dessau-Roßlau is used for the manufacture of a parenteral drug with a highly active biological agent.
The aim of this project was the integrated handling of cleaning validation including all development and optimisation activities of the cleaning process in the field of active agent production. Throughout the entire production process, various system components, devices and equipment come into contact with the highly active protein, which necessitated cleaning validation adapted to the process requirements. In the further course of the project, the service life validation was added.
The Merz Group Services GmbH was provided with full support in the area of cleaning validation. Thanks to risk-based validation management and cGMP-compliant cleaning validation of the process areas, the facility was ultimately approved by the FDA.