Claims for Patent: 6,858,179

Summary for Patent: 6,858,179

Title:	Process for producing sterile water for injection from potable water
Abstract:	By treating potable water at a temperature of at least 230.degree. C. (446.degree. F.) and at a pressure at least equal to the pressure of saturated steam at said temperature, can produce pyrogen-free water using treatment times of 0.05 to 5 seconds or less. The addition of an oxidant, in the form of a gas, a liquid, or a solid, further decreases the required treatment time to less than 0.05 second. The reduction n equipment size achieved with this rapid treatment time allows the utilization of treatment units small enough to be easily transported to remote locations or installed in the restricted space environment existing in ships and submarines.
Inventor(s):	Li; Lixiong (Panama City, FL), Renard; Jean J. (Panama City, FL)
Assignee:	Applied Research Associates, Inc. (Albuquerque, NM)
Application Number:	10/376,312
Patent Claims:	1. A process of producing sterile, demineralized, pyrogen free water from potable water in a continuous cycle, said process comprising: passing the potable water through microchannel chambers, passing the potable water through high temperature filters, passing the potable water through a hydrothermal processing reactor, and maintaining the microchannel chambers, the high temperature filters and-the hydrothermal processing reactor at a temperature greater than 230.degree. C. and at a pressure greater than the pressure of saturated steam at said temperature to produce sterile, demineralized, pyrogen free water from potable water in a treatment time of less than five seconds, in the hydrothermal processing reactor. 2. A process as claimed in claim 1, wherein an oxidant is added to reduce treatment time. 3. A process as claimed in claim 2, wherein the oxidant is in a form of one of a gas, a liquid and a solid. 4. A process as claimed in claim 1, wherein a purging cycle is conducted at a temperature in the range of 100 to 200.degree. to dissolve deposited solids. 5. A method of producing sterile, pyrogen-free water, said method comprising the steps of: pressurizing feed water from a potable water source to keep said feed water substantially in a liquid phase; heating said feed water to a temperature to react at said temperature for a sufficient amount of time to produce sterile, pyrogen-free water; cooling said sterile, pyrogen-free water; and depressurizing said sterile, pyrogen-free water. 6. The method as claimed in claim 5, wherein said sterile, pyrogen-free water is produced in a continuous-flow process. 7. The method as claimed in claim 5, wherein said pressurized and heated feed water serves as a means to sterilize and depyrogenate process equipment as the feed water is converted into said sterile, pyrogen-free water. 8. The method as claimed in claim 5, wherein an adjustment of at least one of said temperature and said time is made according to a predetermined temperature-time correlation curve to produce said sterile, pyrogen-free water. 9. The method as claimed in claim 5, wherein an adjustment of at least one of said temperature and said time is made according to established parameters derived from characterizations of said water. 10. The method as claimed in claim 1, wherein said temperature is at least about 230.degree. C. and said pressure is above saturation pressure at said temperature. 11. The method as claimed in claim 10, wherein reaction time to achieve said sterile, pyrogen-free water is less than about 0.21 minute. 12. The method as claimed in claim 10, wherein reaction time to achieve sterile, pyrogen-free water is less than about 0.1 minute. 13. The method as claimed in claim 5, wherein said temperature and said pressure are above 374.degree. C. and 221 bar, respectively. 14. The method as claimed in claim 13, wherein reaction time to achieve sterile, pyrogen-free water is about 0.02 minute. 15. The method as claimed in claim 5, wherein said temperature is about 450.degree. C. and said pressure is about 250 bar. 16. The method as claimed in claim 15, wherein reaction time to achieve sterile, pyrogen-free water is less than about 0.02 minute. 17. The method as claimed claim 5, wherein said cooling and said depressurizing steps take place in sequence without substantial evaporation of said sterile, pyrogen-free water. 18. The method as claimed in claim 5, wherein said cooling step takes place at one of after and simultaneously with said depressurizing step. 19. A method of producing sterile, pyrogen-free water, said method comprising the steps of: pressurizing feed water from a potable water source to keep said feed water substantially in a liquid phase; introducing an oxidant into the feed water; heating said feed water to a temperature to react at said temperature for a sufficient amount of time to produce sterile, pyrogen-free water; cooling said sterile, pyrogen-free water; and depressurizing said sterile, pyrogen-free water. 20. The method as claimed in claim 19, wherein said oxidant is introduced into the feed water at one of prior to said pressurizing step, afer said pressurizing step, prior to said heating step and after said heating step. 21. The method as claimed in claim 19, wherein said sterile, pyrogen-free water is produced in a continuous-flow process. 22. The method as claimed in claim 19, wherein said pressurized and heated feed water serves as a means to sterilize and depyrogenate process equipment as the feed water is converted into said sterile, pyrogen-free water. 23. The method as claimed in claim 19, wherein an adjustment of at least one of said temperature and said time is made according to a predetermined temperature-time correlation curve to produce said sterile, pyrogen-free water. 24. The method as claimed in claim 19, wherein an adjustment of at least one of said temperature and said time is made according to established parameters derived from characterizations of said water. 25. The method as claimed in claim 19, wherein the temperature is at least about 230.degree. C. 26. The method as claimed in claim 25, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.11 minute. 27. The method as claimed in claim 25, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.01 minute. 28. The method as claimed in claim 19, wherein the temperature and pressure are above 374.degree. C. and 221 bar, respectively. 29. The method as claimed in claim 28, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.005 minute. 30. The method as claimed in claim 19, wherein the temperature is about 450.degree. C. and pressure is about 250 bar, respectively. 31. The method as claimed in claim 30, wherein reaction time to achieve said sterile, pyrogen-free water is less than about 0.005 minute. 32. The method as claimed in claim 19, wherein said oxidant is an oxygen-containing compound that leaves no detrimental residues in said sterile, pyrogen-free water. 33. The method as claimed in claim 32, wherein said oxidant is hydrogen peroxide. 34. The method as claimed in claim 32, wherein said oxidant is oxygen. 35. The method as claimed in claim 19, wherein said cooling and said depressurizing steps take place in sequence without substantial evaporation of said sterile, pyrogen-free water. 36. The method as claimed in claim 19, wherein said cooling step takes place at one of after and simultaneously with said depressurizing step. 37. The method of producing sterile water for injection, said method comprising the steps of: pressurizing feed water from a potable water source to a predetermined pressure; filtering said feed water; rejecting at least a portion of said feed water containing a predetermined concentration of impurities; heating said feed water to a temperature to react at said temperature for a sufficient amount of time to produce sterile, pyrogen-free water; filtering said sterile, pyrogen-free water at said temperature and said pressure; cooling said sterile, pyrogen-free water; depressurizing said sterile, pyrogen-free water via multi-effect flash evaporation; rejecting the portion of said water containing the predetermined concentration of impurities at each stage of said evaporators; passing said treated water through sensors to determine quality of said water; and returning said rejected water back to a process inlet if any required quality of the sterile pyrogen-free water is not satisfied. 38. The method as claimed in claim 37, wherein said sterile water for injection is produced in a continuous-flow process. 39. The method as claimed in claim 37, wherein said pressurized and heated feed water serves as a means to sterilize and depyrogenate process equipment as the feed water is converted into said sterile, pyrogen-free water. 40. The method as claimed in claim 37, wherein an adjustment of at least one of said temperature and said time is made according to a predetermined temperature-time correlation curve to produce said sterile, pyrogen-free water. 41. The method as claimed in claim 37, wherein an adjustment of at least one of said temperature and said time is made according to parameters derived from characterizations of said water. 42. The method as claimed in claim 37, wherein said temperature is at least about 230.degree. C. and said pressure is above saturation pressure at said temperature. 43. The method as claimed in claim 42, wherein reaction time to achieve sterile pyrogen-free water is less than about 0.21 minute. 44. The method as claimed in claim 42, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.1 minute. 45. The method as claimed in claim 42, wherein said temperature and said pressure are above 374.degree. C. and 221 bar, respectively. 46. The method as claimed in claim 45, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.02 minute. 47. The method as claimed in claim 42, wherein said temperature is about 450.degree. C. and said pressure is about 250 bar. 48. The method as claimed in claim 47, wherein reaction time to achieve said sterile, pyrogen-free water is less than about 0.02 minute. 49. A method of producing sterile water for injection, said method comprising the steps of: pressurizing feed water from a potable water source; filtering said feed water; rejecting at least a portion of said feed water containing a predetermined concentration of impurities; introducing an oxidant into the feed water; heating said feed water to a temperature to react at said temperature for a sufficient amount of time to produce sterile, pyrogen-free water; filtering said sterile, pyrogen-free water at said temperature and said pressure; cooling said sterile, pyrogen-free water; depressurizing said sterile, pyrogen-free water via multi-effect flash evaporation; rejecting the portion of said water containing the predetermined concentrations of impurities at each stage of said evaporators; passing said sterile, pyrogen-free water through sensors to determine quality of said water; and returning said rejected water back to a process inlet if any required quality of the sterile, pyrogen-free water is not satisfied. 50. The method as claimed in claim 49, wherein said oxidant is introduced into the feed water at one of prior to said pressurizing step, after said pressurizing step, prior to said heating step and after said housing step. 51. The method as claimed in claim 49, wherein said sterile water for injection is produced in a continuous-flow process. 52. The method as claimed in claim 49, wherein said pressurized and heated feed water serves as a means to sterilize and depyrogenate process equipment as the feed water is converted into said sterile, pyrogen-free water. 53. The method as claimed in claim 49, wherein an adjustment of at least one of said temperature and said time is made according to a predetermined temperature-time correlation curve to produce said sterile, pyrogen-free water. 54. The method as claimed in claim 49, wherein an adjustment of at least one of said temperature and said time is made according to parameters derived from characterizations of said water. 55. The method as claimed in claim 49, wherein the temperature is at least about 230.degree. C. 56. The method as claimed in claim 55, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.11 minute. 57. The method as claimed in claim 55, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.01 minute. 58. The method as claimed in claim 49, wherein the temperature and pressure are above 374.degree. C. and 221 bar, respectively. 59. The method as claimed in claim 58, wherein reaction time to achieve said sterile, pyrogen-free water is about 0.005 minute. 60. The method as claimed in claim 49, wherein the temperature is about 450.degree. C. and pressure is about 250 bar. 61. The method as claimed in claim 60, wherein reaction time to achieve said sterile, pyrogen-free waters is less than about 0.005 minute. 62. The method as claimed in claim 49, wherein said oxidant is an oxygen-containing compound that leaves no detrimental residues in said sterile water for injection. 63. The method as claimed in claim 62, wherein said oxidant is hydrogen peroxide. 64. The method as claimed in claim 62, wherein said oxidant is oxygen.

Details for Patent 6,858,179

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		2020-02-04