Methods for the on-line, on-demand preparation of sterile, water-for-injection grade water
OwnerPeter Grandicsinventor
Life of this patent
Estimating the term…
Abstract
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.
Claims16
A method for on-line, on-demand production of sterile, water-for-injection grade water comprising the steps of:
- (a) filtering the water by membrane filtration;
- (b) sterilizing the water by chemical sterilization using solid phase iodine;
- (c) reducing iodine released from the solid phase iodine to iodide;
- (d) deionizing the water to remove iodide, residual dissolved salts, and endotoxin and
- (e) removing pyrogens by perfusion through an adsorbent that removes pyrogens.
A method for on-line, on-demand production of sterile, water-for-injection grade water comprising the steps of:
- (a) filtering the water by membrane filtration;
- (b) sterilizing the water by chemical sterilization using solid phase iodine on an immobilized iodine column prepared by adsorbing Kl3 to an agarose-based strong anion exchanger containing quaternary amine groups;
- (c) reducing iodine released from the solid phase iodine to iodide by using a solid phase adsorbent that has thiol groups on an agarose-based adsorbent;
- (d) deionizing the water to remove iodide, residual dissolved salts, and endotoxin;
- (e) removing pyrogens through an adsorbent that removes pyrogens and that is a polymeric cross-linked agarose support derivatized with a multiplicity of ligands that comprise a stearylamino group and that specifically bind endotoxin to remove pyrogens below the level of 0.005 EU/ml;
- and
- (f) filtering the water after the removal of pyrogens in step (e) with a final filtration step.
Dependencies are inferred from the claim text.