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WFI Ph. Eur. aus Membranverfahren
Die überarbeitete Monografie: Wasser für Injektionszwecke (0169) – Ph. Eur. Supplement 9.1
Over the last years, experiences made with the water quality grade „Highly Purified Water“ (HPW) show reliable results of the quality Water for Injection (WFI) produced by Reverse Osmosis. Nevertheless, in cold producing purification systems (15–25 °C), there is a potential risk of biofilm formation and endotoxins. Even by taking into account possible design failures, malfunctions or lacks of microbiological and hygienic knowledge of external service technician, the risk is significantly lower in hot WFI producing evaporation systems. Therefore, the need of a valid system layout, a decent hygienic design, and reliable maintenance services become essential in cold producing systems. Ultrafiltration (UF) is to be considered the final processing step and last barrier for microorganisms and endotoxins in cold producing water purification systems. In the event of biofilm formation on the resin of the electrodeionization (EDI) system, the UF serves as a protective barrier. As a consequence, innovations for proper and valid integrity testing and endotoxin challenge tests are expected to be developed by the supplying industry of UF modules. Without any doubt, the advantages of the established and approved hot WFI generation and distribution system will definitely accompany the industry for a long time.
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