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Purified Water: Erweiterung einer bestehenden Anlage, Qualifizierung und Validierung

Hans-Jürgen Eisinger Protein Processing Biotechnology Production

Novartis Pharma AG, Basel (Schweiz) 70565 Stuttgart (Germany)

Purified Water: Extension of an Existing Production Plant, Qualification, and Validation During the construction of a biotech production plant, existing components for the production of purified water were combined and extended. In the plant described here, purified water, free of endotoxins, is produced from drinking water. Two independent water storage and distribution systems are operated, which comprise together 80 take-off and sampling points. In this presentation, the procedures for qualification and validation will be described, in particular Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). Examples will also be shown. The sub-division of IQ into IQ 01 and IQ 02, respectively, the sub-division of OQ into OQ 01, OQ 02 and OQ 03, has proved to be helpful, although it is not absolutely essential. The elements of preventative maintenance will also be described along with examples of the appropriate plans. The purified water plant is currently operating without problems and has been inspected by the European Authorities.

Key words Gereinigtes Wasser · Produktionsanlagen, pharmazeutische · Qualifizierung · Validierung · Wasseranlagen, pharmazeutische