Cleaning validation of a fermentation group for the production of biomedical products [Cleaning validation di un gruppo prefermentatore-fermentatore per la produzione di prodotti biomedicali]

The fermentation-group is largely employed to produce pharmaceuticals by means of biotechnology techniques. The operative functions of these plants are surely kept under control by the validation process, while its cleaning is less investigated. The aim of this work is the cleaning validation of a fermentation-group. Furthermore, Standard Operative Procedures (SOPs) have been validated relating to the production necessities and to the allowed safety limits.