Divisions Produce On-Demand IV Solutions for Hospitals, Medical IndustryAugust 2011
IV fluids are an essential element in treating battlefield casualties. Currently, war reserve material warehouses and field hospitals stock large numbers of IV bags due to the logistic limitations on resupply and the necessity to be prepared for the worst: heavy casualties in a surge operation. IV fluid storage is further limited by shelf life, resulting in most of those bags transported at great expense expiring before they ever get used.
The U.S. Air Force is promoting a visionary medical technology known as Field Intravenous Fluid Reconstitution (FIVR) to reduce logistic costs by filling intravenous bags as needed at battlefield hospitals. FIVR technology will simplify logistics, eliminate waste, and ensure that our soldiers receive the life saving fluids they need. The FIVR system consists of three component technologies: 1) the compact Sterile Water for Injection (SWFI) generator, 2) the automated bag-filling machine, and 3) the sterile, preloaded IV bags.
Applied Research Associates is well on its way to proving the FIVR technology. In 1999, Dr. Lixiong Li and Dr. Jean Renard of ARA’s Engineering Science Division in Panama City, Fla., identified a military need for compact systems to produce sterile water and obtained funding from the Office of Naval Research’s Small Business Technology Transfer Program. By 2004, the ARA team had successfully demonstrated and patented a compact SWFI generator. The Navy program resulted in designation of the SWFI generator as a medical device by the U.S. Food and Drug Administration.
Since 2007 ARA has been the prime contractor for the Air Force’s FIVR program. The goal is to build and validate FIVR systems to obtain FDA approval of the FIVR device and IV fluids. The FIVR system is being designed for minimal operator assistance. Preloaded IV bags will be placed in a magazine and the control system-activated. From that point, the machine moves the bag through a series of stations until it is filled with sterile water by the generator. The final constituted bag is then sealed and released for immediate use or temporary storage. The program passed its critical design review in March 2011, moving the Engineering Development Model into the fabrication phase.
The current FIVR team at ARA’s North Florida Division includes Program Manager Dr. Lixiong Li, Deputy Program Manager Sheryl Calidonna and seven other team members responsible for engineering, validation, test and evaluation, and quality assurance. CoreRx Pharmaceuticals, a contract manufacturing organization in Tampa, will prepare the bags by preloading them with appropriate ingredients and preparing them for terminal sterilization. “In this form, these bags will be shown to have a shelf life that far exceeds current commercial shelf lives for IV solutions,” Li said.
The large project also involves seven other subcontractors, several service laboratories, and FDA compliance consultants.
ARA believes the technology has even more potential in civilian markets. Water for Injection (WFI) and Sterile Water for Injection (SWFI) are used in every pharmaceutical facility, and represent about a $30 million market for new equipment.
“Our technology offers lower capital cost, 25 percent lower energy cost, and 1,000 times better product quality than the existing distillation technology,” Li said.
The performance improvement occurs because the ARA-patented process both sterilizes the product and destroys the contaminants such as endotoxins. Going after this market would involve scaling up the SWFI generator part of the system. FDA approval is not required for SWFI generators, but it would definitely ease the mind of potential customers.
There may also be a market for the complete FIVR system at isolated medical facilities, mobile medical units, and emergency relief operations for natural disasters or terrorist attacks. As in the military market, the extended shelf life of the IV bags and reduced logistic demands will be what drives the market.
After 12 years of R&D effort, the technology is poised for commercialization. Brad Yundt, head of ARA’s FIVR engineering team who has more than 30 years of experience designing WFI distillers, is spearheading the company’s effort to identify commercial clients. Since ARA is primarily a research and engineering company, they are seeking partners for manufacturing and distribution.
“The performance of this new technology will whet potential customers’ interest, and the savings in capital and energy costs make it even more compelling,” Li said.
For more information contact Dr. Li at firstname.lastname@example.org or call (850) 914-3188.