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 adsorbent, a final 0.2 microns 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 L/hr. Parenteral solutions were made by adding WFI to an IV bag containing concentrated Ringer's 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 L/min from a pressurized source.
Burrows
W D
WD
U.S. Army Biomedical Research and Development Laboratory, Fort Detrick, Frederick, MD.
Nelson
J H
JH
D002852:Chromatography, Ion Exchange; D005374:Filtration; D007263:Infusions, Parenteral; D007267:Injections; D013242:Sterilization / Q000295:instrumentation / Q000379:methods*; D014867:Water
D014867:Water