| 摘要 |
A new method is described to produce large volumes of low cost sterile, Water-for-Injection (WFI) grade water on-line, on-demand from potable water in order to meet the needs of dialysis therapies and other biological applications for sterile, injectable grade water. The source water is processed by a combination of membrane and column chromatographic methods including reverse osmosis, chemical sterilization, reduction of iodine sterilant to iodide, deionization, endotoxin-specific adsorption and polishing filtration in order to reduce contaminant levels below those specified by the US Pharmacopoeia. |
