info(at)spec-eng.com | phone: 781.221.0123| fax: 781.221.7212|Client Login
Products > Utilities: Water
WFI
WFI Utilities. Water for Injection (WFI) is water that is injected into the human body. It must be purified by distillation or two-stage reverse osmosis. It is usually stored and distributed hot (at 80 degrees C) in order to meet microbial quality requirements. Distillation is the process of heating a liquid until it boils, capturing and cooling the resultant hot vapors, and collecting the condensed vapors. Reverse osmosis is a separation process that uses pressure to force a solution through a membrane that retains the solute on one side and allows the pure solvent to pass to the other side.
Things to Consider When Purchasing This Product:
Storage in continuosly circulating system with turbulent flow, Maintained at 80-85C, Stainless steel preferred material of construction, Interior surfaces highly polished then electropolished then passivated, Dead zones in system eliminated or minimized, Pretreatment of feed water to remove chlorine compounds, Percolation through ion exchange media, Distillation or reverse osmosis filtration as final step, System design for easy drainage and frequent sanitizing, Product water output rate (L/hour), Gravity feed to storage tank in close proximity to treatment (avoid use of transfer pumps or extensive piping), Validation process (installation qualification/operational qualification/performance qualification), Meet specifications in United States Pharmacopeia, USP 24 Specification for Water Purity for WFI: Conductivity < 2.1 microS/cm at 25C, Total Organic Carbon (TOC) < 500ppm, Microbial (recommended Action Limit) 10 cfu/100mL, Endotoxin < 0.25 EU/mL, Production method either distillation or reverse osmosis










