IV Fluidmaker III. Test and Evaluation of 1 L/HR Prototype

摘要

Hand-operated fluidmakers capable of producing 1 L/hr of water for injection havebeen tested for their ability to remove endotoxins, oxidizables, chloride and bacteria from a challenge water having high levels of all measured parameters. Three fluidmakers consisted of a reverse osmosis unit, an ion exchange column, a water purification filter and a sterilizing filter in series; two others were identical except for the lack of ion exchange columns. Three fluidmakers failed before 50 L of product water was collected, probably because of excessive back pressure resulting from clogged sterilizing filters. A number of samples of product water exhibited endotoxin contamination, and several were not sterile. All samples were out of limit for chloride ion, and 10 percent were out of limit for oxidizables. A sixth fluidmaker (without an ion exchange column) was operated for 50 L by means of a mechanical cycling machine. Sterilizing filters were changed after every liter of product water, the reverse osmosis unit functioned normally, and the product water was sterile and nonpyrogenic.