Privatsphäre-Einstellungen

Innovative Verfahren zur Herstellung von Gereinigtem Wasser

Jochen Schmidt-Nawrot

Philipp Müller · Hager + Elsässer GmbH, Stuttgart

Water is one of the most important constituents for the manufacturing of pharmaceutical products. Varying requirements are imposed on the quality of water according to the manufacturing process the water is applied to, mainly it is differentiated between “Purified Water” (PW) and “Water for Injection” (WFI). The water treatment systems in use have to obtain the GMP requirements in the EU and of FDA and have to be qualified and validated. For production of purified water ion exchange technologies are in use as well as membrane systems. Mostly applied today is the permeate-staged reverse osmosis and the combination of reverse osmosis and electrodeionisation (EDI). The recently developed membrane degasification is used more and more for the separation of CO₂. All these technologies and systems are manufactured by qualified suppliers in a high quality standard according GMP design with the required materials, surface qualities, calibrated measuring instruments and a monitoring system with visualisation. The plants will be pre-assembled in the suppliers’ facilities and commissioned on site. The documentation contains the necessary qualification documents including certificates and testimonials.

Key Words Elektrodeionisation · Gereinigtes Wasser · Ionenaustausch · Membranentgasung · Umkehrosmose · Wasseraufbereitung, pharmazeutische