Claims for Patent: 6,485,649

Summary for Patent: 6,485,649

Title:	Method and device for the production of pure water
Abstract:	Input water is preheated in a heat exchanger (2), pumped (4) through another heat exchanger (5) into a heating unit (6). The heating unit heats the water to a temperature of above 100.degree. C., preferably 140-150.degree. C., while maintaining the water in a liquid state without vaporization. A pump (8) feeds the heated water under sufficient pressure to prevent vaporization to at least one crossflow filtration unit (9). A portion of the heated water passes through a thermally stable filtration material having a pore size of 1-20 nanometers for filtering endotoxins and pyrogens, 4-10 nanometers for filtering viruses, or 100 nanometers-30 .mu.m for filtering bacteria. Heated water which has passed through the filtration material is fed through a pure water product outlet of the filtration unit to a pure water outlet (16). A retenate portion of the heated water flows past the filtration material to carry filtered impurities through a retenate output line (10). To conserve energy, the retenate output line passes through the heat exchanger (2) and the pure water product line passes through the heat exchanger (5) to preheat the incoming water. A backflushing valve (7) selectively passes pure water product backward through the filtration material to backflush impurities trapped in the filtration material.
Inventor(s):	Terava; Jorma (Lempaala, FI), Nurminen; Teppo (Vantaa, FI)
Assignee:	Steris Europe, Inc. (Camberly, GB)
Application Number:	09/554,293
Patent Claims:	1. A continuous method for producing pure water by means of heat sterilization and filtration comprising: heating water without evaporation to a temperature above 100.degree. C. for a time sufficient (i) for achieving a predetermined sterility level in said water, and (ii) for keeping the apparatus confining the water during said sterilization step sterile during production; crossflow filtering the heated water under heat sterilizing conditions at essentially the temperature of the sterilization step. 2. The method according to claim 1 wherein the pure water from the crossflow filtering step is "water for injection" quality. 3. The method according to claim 1 wherein the temperature of sterilization is between 140-150.degree. C. 4. A continuous method for producing pure water by means of heat sterilization and filtration comprising: heating feed water without vaporization to a temperature above 140.degree. C. for a time sufficient to achieve a preselected sterility level in said water; crossflow filtering the heated water at essentially the sterilization temperature. 5. The method according to claim 4 wherein the crossflow filtering step divides the heated water into a permeate water and retentate water and further including: preheating the feed water prior to the heating step with heat from at least one of the permeate water and the retentate water. 6. The method according to claim 5 wherein tie feed water is kept above 100.degree. C. during the crossflow filtering step. 7. A device for producing pure water, the device comprising: at least one filtration unit having sufficient separation power for rendering said water sufficiently pure to satisfy preselected purity standards; a filtration circuit including said filtration unit, which circuit is adapted for holding a temperature above 100.degree. C. and for circulating said water at a temperature above 100.degree. C.; a means for heating water and keeping said heated water in liquid form above 100.degree. C. without vaporization for a period sufficient for sterilization and for maintaining the water in the filtration unit and the filtration circuit above 100.degree. C. during filtering. 8. The device according to claim 7 wherein the separation capacity of said at least one filtration unit is sufficient for producing water for injection. 9. The device according to claim 7 further including a means for transferring heat from water streams leaving the device to feed water. 10. The device according to claim 9 wherein the heat transferring means includes a tube and shell heat exchanger having double end jacket walls. 11. The device according to claim 7 further including a means for measuring a pressure difference between feed and product sides of the filtration units. 12. A method for producing pure water comprising: heating water under pressure to a temperature above 100.degree. C. without vaporization; passing a first portion of the heated water at a temperature above 100.degree. C. through a filter to generate a pure water product stream; passing another portion of the heated water past the filter at a temperature above 100.degree. C. in a retentate flow. 13. The method according to claim 12 wherein in the heating step, the water is heated above 140.degree. C. 14. The method according to claim 12 wherein heat from the retentate flow is transferred to the water prior to the heating step to preheat the water. 15. The method according to claim 12 further including: in the filtering step, blocking impurities with a dimension greater than 20 nanometers from passing through the filter to the pure water product flow and retaining the blocked impurities in the retentate flow. 16. The method according to claim 12 further including: forcing a flow of the pure water product flow back through the filter to backflush impurities trapped in the filter into the retentate flow. 17. The method according to claim 12 wherein, in the passing steps, the heated water is maintained above 100.degree. C. 18. The method according to claim 12 further including: monitoring pressure across the filter; in response to the monitored pressure reaching a preselected set point pressure, backflushing the filter. 19. A pure water generator comprising: a crossflow filtration unit having: a heated water input through which heated water is received, a pure water product outlet through which heated water that has passed through a thermally stable filter material is discharged, and a retentate output through which heated water and impurities which are too large to pass through the filter material are discharged; a heater connected with the heated water input which heats input water to a temperature sufficiently above 100.degree. C. to maintain the water in the crossflow filtration unit above 100.degree. C. during filtering from the heated water input to the pure water product outlet. 20. The pure water generator according to claim 19 wherein the filter material has a pore size in the range of 1-20 nanometers for filtering endotoxins and pyrogens. 21. The pure water generator according to claim 19 wherein the filter material has a pore size in the range of 4-10 nanometers for filtering viruses. 22. The pure water generator according to claim 19 wherein the filter material has a pore size in the range of 100 nanometers to 30 .mu.m for filtering bacteria. 23. The pure water generator according to claim 19 further including a second crossflow filtration unit having: a heated water input through which heated water from the heater is received, a pure water product outlet through which heated water that has passed through a thermally stable filter material is discharged, and a retentate output through which heated water and impurities which are too large to pass through the filter material are discharged. 24. The pure water generator according to claim 23 further including: a valve connected between the pure water product outputs of the first and second filtration units for selectively feeding back pure water product to each of the filtration units to backflush impurities trapped in the filter material into the retentate flow. 25. The pure water generator according to claim 19 further including: a pump disposed between the heater output and the filtration unit input to raise a pressure of the heated water. 26. The pure water generator according to claim 19 further including: a heat exchanger connected with the input water line and connected with one of the pure water product outlet and the retentate output for transferring heat from the pure water product or the retentate to the input water. 27. The pure water generator according to claim 26 further including: a second pump for pumping input water to the heat exchanger; and a second heat exchanger disposed upstream from the second pump for preheating water pumped by the second pump, the second heat exchanger being connected with the other of the retentate output and the pure water product outlet. 28. A continuous method for producing pure water comprising: heating water without evaporation to a temperature above 100.degree. C. for a time sufficient to sterilize said water; crossflow filtering the heated sterile water to generate a retentate water flow and a pure water flow, keeping the sterile water heated to above 100.degree. C. during the crossflow filtering. 29. A device for producing pure water, the device comprising: a crossflow filter having a sterile water input, a permeate output, and a retentate output; a heater means connected with the sterile water input for heating the sterile water without evaporation above 100.degree. C. and keeping the water in the crossflow filter above 100.degree. C. during filtering.

Details for Patent 6,485,649

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2017-11-12