| Media Fill bei mehrstufigen Prozessen |
Novartis Pharma AG, Stein (Schweiz)
Media Fills in Multi-stage Processes
Multi-stage media fills are defined as microbiological validations of aseptic production or filling procedures which are conducted using partly independent processes and procedures. While the validation of conventional aseptic filling procedures such as the filling of ampoules or vials is wellknown in the pharmaceutical industry, there is still a lack of knowledge about the procedures and validation of multi-stage media fills. In contrast to conventional aseptic filling procedures, multi-stage media fills cannot easily be generalised and are usually more complex. For each multi-stage media fill a detailed process knowledge is necessary, according to which a specific media fill concept has to be established.
The following article will provide an approach to establishing a multi-stage media fill focusing on an aseptic bulk production.
Key words Aseptische Bulk-Herstellung, Akzeptanzkriterien • Media Fill • Mehrstufige Prozesse • Personenqualifizierung • Worst-case-Parameter