Intravenous (4) Fluidmaker 4. A Disposable Device for Preparation of SterileWater for Injection in a Field Setting

摘要

A small, disposable system has been developed to prepare USP Sterile Water forInjection (WFI) from a pressurized potable source. The system comprises, in series, a standard laboratory strong acid/strong base ion exchange column, an activated carbon water purification filter, a fine particle filter, a 0.2 um sterilizing filter and a Resuscitation Fluids Production System (REFLUPS) 18 L bag set, which is filled by means of a 19-port distribution head. This system is capable of generating sterile, pyrogen-free water at a fill rate of 0.5 L/min. Product resistivity did not consistently meet the 1.0 megohm limit corresponding to the USP standard for dissolved salts; a second, smaller, ion exchange cartridge will be required.