IV Fluidmakers: Preparation of Sterile Water for Injection in a Field Setting

Two approaches have been investigated for generating USP sterile, pyrogen-free water for injection WFI from potable water in the field. The first approach utilizes reverse osmosis RO, ion exchange, a solid matrix filter containing activated carbon and zeta absorbent, a final 0.2 micrometer pore size sterilizing filter and a device for transferring the WFI to an IV bag prototype systems based on three different hand-operated RO units weigh 1.5-3.5 kg and are capable of producing WFI at rates of 1-10 Lhr. Parenteral solutions were made by adding WFI to an IV bag containing concentrated Ringers lactate. The second approach, still in the breadboard stage, is similar but utilizes a larger ion exchange column in place of the RO unit and a multiport distribution head to fill a set of 18 1-L IV bags. This system, considered to be disposable, is capable of generating water of WFI quality at a fill rate of 0.5 Lmin from a pressurized source.