UltraPure Steam in Water for Injection
Water for injection (WFI) is water that is converted to steam in multi-step stills and then condensed under aseptic conditions. RASIRC eliminates pyrogen carryover by purifying the steam with a non-porous material. The purification segment of the technology is disposable to minimize cross contamination and simplify GMP and validation processes.
Alternate technologies require large stainless steel stills. WFI made in metal stills will pick up metal ion contamination, including iron, chrome, nickel, and other toxic metals with unknown effects on the end use of the water. The scalability of the steam purification device enables ultrapure steam that is particle and metal free to be delivered locally in quantities from ml/hour up to liters/hour.
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