Remote site production of sterile purified water from available surface water

A water purification and sterilization device was tested for its functional capabilities. Challenge water consisting of potable water augmented with bacteria, endotoxin, virus, suspended solids, and dissociable ions (sodium chloride, lead or arsenic salts) was passed through the device. The product water quality attributes were analyzed. The device demonstrated reduction in bacteria of >7 logs, endotoxin was reduced by >4 logs, virus was reduced by >4 logs, and dissociable ions were reduced by >3 logs. The product water of the device met the limits for a range of chemical entities specified by the United States Pharmacopeia and Association for the Advancement of Medical Instrumentation. The product water met the quality attributes of Sterile Water for Injection, USP, Sterile Purified Water, USP, and the Water for Dialysis. The device provides a logistical advantage in reducing the weight of transport of packaged water by 83% and the cube by 67%. It operates manually by gravity and is disposable after a single use. The device provides an effective alternative to the transport and use of packaged sterile water in remote locations by production of sterile water at the point-of-need using available water. It also is capable of producing safe drinking water following the production of clinical waters. This device has been cleared by the US Food and Drug Administration for production of three liters Sterile Purified Water, USP from Environmental Protection Agency (EPA) grade drinking water.