EP0056855A2
Expired / Lapsed
EP
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Preparation of infusion grade water
Assignee: Gulf South Research Institute Te Baton Rouge Loui
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Filing: 1981-11-27
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Granted: —
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Expires: 2001-11-27
Abstract
Abstract An apparatus is disclosed for the preparation of infusion grade water for use in the preparation of parenteral solutions. The apparatus is comprised of a two component system including a chemical purification unit and an endotoxin filter receiving assembly (80). Chemical purification of the water is achieved by treating the feed water using a sequence of carbon adsorption, reverse osmosis, deionization, and membrane filtration. The chemically pure water from this system is used as a feed water to a low molecular weight cutoff membrane ultrafilter (82), which is an integral part of a presterilized manifold (90) with receiving bags (92). The receiving bags (92) may contain premeasured solutes in sterile nonpyrogenic powder form or in concentrated solution form to yield by dilution typical parenteral solutions ready for administration.
Inventors
- 👤 Elias Klein
- 👤 Douglas J. Beach
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-08 21:18
CPC Classifications
B; B01; B01D; B01D61/00; B01D61/58; A; A61; A61K; A61K47/00; A61K47/02; A61K9/00; A61K9/0012; A61K9/0019; A61L; A61L2/00; A61L2/02; A61L2/022; B01D61/02; B01D61/08; B01D63/00; B01D63/02; B01D63/025; B01D63/10; B01D71/00; B01D71/06; B01D71/40; B01D71/42; B01D71/421; C; C02; C02F; C02F1/00; C02F1/44; C02F1/441; B01D2311/00; B01D2311/02; B01D2311/06; B01D2313/00; B01D2313/18; B01D2313/30; B01D2313/40; B01D2313/44; B01D2313/90; B01D2313/903; B01D2317/00; B01D2317/04; B01D61/025; B01D61/14; B01D61/145; C02F1/28; C02F1/283; C02F1/42; C02F1/444; C02F2103/00; C02F2103/02; C02F2103/026
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
143 words
Apparatus for generating infusion grade water from feed water, characterized in that the apparatus comprises a chemical purification assembly in combination with an endotoxin filter output assembly for generating nonpyrogenic water, the chemical purification assembly including a first filter for removing gross particulate and organic impurities from feed water to provide filtered water, reverse osmosis purification means connected to said first filter for generating permeate water from said filtered water, deionization means connected to the reverse osmosis means for deionization of said permeate water, and a second filter for filtering the deionized permeate water to produce chemically pure water; and the said endotoxin filter output assembly including an endotoxin filter adapted to remove from said chemically pure water lipopolysaccharides derived from gram-negative bacteria, for generating nonpyrogenic water, and receiving means integrally sealed with the endotoxin filter for receiving and storing said nonpyrogenic water.
Claim 2
Dependent Claim
143 words
Apparatus for generating infusion grade water from feed water, characterized in that the apparatus comprises a chemical purification assembly in combination with an endotoxin filter output assembly for generating nonpyrogenic water, the chemical purification assembly including a first filter for removing gross particulate and organic impurities from feed water to provide filtered water, reverse osmosis purification means connected to said first filter for generating permeate water from said filtered water, deionization means connected to the reverse osmosis means for deionization of said permeate water, and a second filter for filtering the deionized permeate water to produce chemically pure water; and the said endotoxin filter output assembly including an endotoxin filter adapted to remove from said chemically pure water lipopolysaccharides derived from gram-negative bacteria, for generating nonpyrogenic water, and receiving means integrally sealed with the endotoxin filter for receiving and storing said nonpyrogenic water.
Claim 3
Dependent Claim
37 words
Apparatus according to claim 1, further characterized in that the first filter comprises a carbon adsorption filter in the form of a disposable carbon pack having an affinity for free chlorine, chloramines and organics including chlorinated hydrocarbons.
Claim 4
Dependent Claim
41 words
Apparatus according to claim 1 or claim 2, further characterized in that it includes a fines filter having a 5 micron cutoff, connected to the first filter, for protecting the downstream components from fine particulate material emanating from the first filter.
Claim 5
Dependent Claim
61 words
Apparatus according to any one of claims 1 to 3, further characterized in that the reverse osmosis purification means comprises membrane cartridges which are plumbed in parallel and are connected to the said first filter, each of the cartridges comprising spiral wound modules having membranes capable of resisting attack by chlorine, and operable in a pH range between 3 and 11.
Claim 6
Dependent Claim
35 words
Apparatus according to any one of claims 1 to 4, further characterized in that it includes a recirculation system including a valve and conduit for controllably recirculating retentate back to the reverse osmosis purification means.
Claim 7
Dependent Claim
42 words
Apparatus according to any one of claims 1 to 5, further characterized in that it includes a temperature compensated conductivity cell in combination with a resistivity monitor for determining the conductivity of said chemically pure water delivered by the said second filter.
Claim 8
Dependent Claim
51 words
Apparatus according to claim 6, further characterized in that the monitor includes circuitry for sounding an alarm if the quality of the water fails to meet predefined levels of conductivity, and a three-way electronic valve controlled by the monitor for diverting water from the endotoxin filter output assembly to a drain.
Claim 9
Dependent Claim
22 words
Apparatus according to any one of claims 1 to 7, further characterized in that the endotoxin filter is a polyacrylonitrile hollow-fiber hemofilter.
Claim 10
Dependent Claim
45 words
Apparatus according to any one of claims 1 to 8, further characterized in that the said receiving means includes a manifold having a plurality of tees, each tee having a bag for receiving infusion grade water, the manifold being integrally sealed with the endotoxin filter.
Claim 11
Independent Claim
102 words
A method of preparing infusion grade water, characterized in that it comprises the steps of chemically purifying a potable feed water by adsorbing gross particles and organic impurities from the feed water to produce filtered water, purifying the filtered water by reverse osmosis to generate a permeate water, deionizing the permeate water, microfiltering the deionized permeate water to produce a chemically pure water; and retentive ultrafiltering the chemically pure water in a retentive ultrafiltering system for the removal of endotoxins to generate infusion grade water, and storing the infusion grade water in a receiving system integrally sealed with the retentive ultrafiltering system.
Claim 12
Independent Claim
102 words
A method of preparing infusion grade water, characterized in that it comprises the steps of chemically purifying a potable feed water by adsorbing gross particles and organic impurities from the feed water to produce filtered water, purifying the filtered water by reverse osmosis to generate a permeate water, deionizing the permeate water, microfiltering the deionized permeate water to produce a chemically pure water; and retentive ultrafiltering the chemically pure water in a retentive ultrafiltering system for the removal of endotoxins to generate infusion grade water, and storing the infusion grade water in a receiving system integrally sealed with the retentive ultrafiltering system.
References Cited (Backward Citations)
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