Betriebs- und Reindampf im pharmazeutischen Produktionsprozeà Norbert Bandau und Sven Pommeranz Concept Heidelberg, Technisches Büro Nord, Goslar Process and Pure Steam for Pharmaceutical Manufacture Many pharmaceutical methods employ steam for thermal processes. One usually differentiates between two steam qualities: process steam and pure steam. In the following article the particular requirements for process steam and pure steam systems in the pharmaceutical environment will be compared. The article seeks to provide planners and operators of such installations with a decision-making aid for defining pure steam qualities. In addition, it describes the basic principles and design criteria for the layout of such installations, and discusses qualification and validation aspects. Key words Betriebsdampf · Dampfanlagen, Designkriterien, Qualifizierung, Validierung · Reindampf |