Claims for Patent: 7,122,149

Summary for Patent: 7,122,149

Title:	Apparatus and method for continuous depyrogenation and production of sterile water for injection
Abstract:	A fluid processor, suitable for the production of sterile water for injection, having a processor assembly and a process control system comprising a pump, a flow splitter, flow restrictors and a pressure relief valve. In a preferred embodiment, the processor assembly comprises a heat exchanger, a reactor and a heater arranged in a nested configuration. The preferred embodiment of the present invention also include a treatment assembly having a combination of filter, reverse osmosis and ion exchange devices and further incorporates an assembly and method allowing for the in situ sanitization of the fluid processor during cold start and shutdown to prevent bacteria growth during storage of the fluid processor. The fluid processor may include an electronic control system comprising a touch screen operator interface, a programmable logic controller and sensors for measuring temperature, pressure, flow rate, conductivity and endotoxin level.
Inventor(s):	Li; Lixiong (Panama City, FL), Campbell; Timothy J. (Panama City, FL), Nichols, Jr.; Robert K. (Panama City, FL), Cozart; Kristopher S. (Panama City, FL)
Assignee:	Applied Research Associates, Inc. (Albuquerque, NM)
Application Number:	10/618,133
Patent Claims:	1. A fluid processor comprising: a pump for drawing a fluid from a fluid source through a fluid inlet and pressurizing the fluid; a processor assembly for processing the fluid from the pump, the processor assembly comprising: a heat exchanger for recovering thermal energy; a reactor for processing a fluid by heating: and a heater for heating the reactor; a process control system comprising: a flow splitter disposed between the pump and the processor assembly for diverting a portion of the fluid from the pump, a first flow restrictor for receiving the diverted fluid and directing the diverted fluid to the fluid inlet, a pressure relief valve disposed between the first flow restrictor and the flow splitter, and a second flow restrictor disposed downstream of the processor assembly, wherein the flow splitter, first flow restrictor, second flow restrictor and pressure relief valve are constructed and arranged to coact with each other to control the pressure and flow rate of the fluid in the fluid processor; a sanitization assembly comprising: an isolation valve disposed immediately downstream of the fluid inlet a drain valve disposed at the lowest point of the fluid processor and between the pump and the processor assembly; and a startup loop assembly comprising: a first fluid path running from the isolation valve to the reactor; a second fluid path running from the isolation valve to the pump; a startup flow restrictor disposed immediately downstream of the isolation valve and positioned along the first fluid path; and a four-way valve disposed immediately downstream of the startup flow restrictor and the pump, the four-way valve-having a first connection for receiving fluid from the startup flow restrictor, a second connection for directing fluid from the startup flow restrictor to the reactor, a third connection for receiving fluid from the pump, and a fourth connection for directing the fluid from the pump to the heat exchanger, and further, wherein the four-way valve has a startup position for directing fluid from the startup flow restrictor to the reactor through the first and second connection and a normal position for directing the fluid from the pump to the heat exchanger through the third and fourth connection. 2. The fluid processor of claim 1, wherein startup flow restrictor is a fixed setting flow restrictor. 3. The fluid processor of claim 1, wherein the startup flow restrictor is an adjustable setting flow restrictor. 4. A method for sanitizing the fluid processor of claim 1 during startup, the method comprising: connecting the fluid inlet to the fluid source wherein the fluid source has a line pressure of not less than about 10 psia and not greater than about 800 psia, switching the four-way valve to the startup position; opening the isolation valve; introducing fluid into the fluid processor at line pressure; switching on the heater; allowing steam generated by the heater to flow downstream of the reactor and exit at a fluid outlet; and switching the four-way valve to the normal position. 5. A method for sanitizing the fluid processor of claim 1 during shutdown and storage, the method comprising: turning off the pump and heater; closing the isolation valve; allowing residual heat of the reactor to produce steam from the fluid in the processor assembly; allowing the steam to generate a pressure in the processor assembly; allowing the pressure to expel the fluid that is downstream of the processor assembly out through a fluid outlet; opening the drain valve to discharge the fluid that is upstream of the processor assembly; attaching a closure means to the fluid outlet when fluid ceases to flow from the fluid outlet and closing the drain valve when the fluid ceases to flow from the drain valve. 6. The method of claim 5, wherein the closure means is a container holding a sterile solution. 7. The method of claim 5, wherein the closure means is a filter. 8. The fluid processor of claim 1, wherein the heat exchanger is a shell-and-tube heat exchanger and further, wherein a process fluid flows through a shell side of the heat exchanger and a product fluid flows through a tube side of the heat exchanger. 9. The fluid processor of claim 1, wherein the heat exchanger is a tube-in-tube heat exchanger and further, wherein a process fluid flows through an annular side of the heat exchanger and a product fluid flows through a tube side of the heat exchanger. 10. The fluid processor of claim 9, wherein the heat exchanger is a helical coil tube-in-tube heat exchanger. 11. The fluid processor of claim 10, wherein the reactor and the heater are nested within the heat exchanger. 12. The fluid processor of claim 11, wherein the reactor and the heater are disposed within a temperature homogenizer. 13. The fluid processor of claim 12, wherein the temperature homogenizer comprises a multiplicity of blocks, the blocks being joined together by fasteners. 14. The fluid processor of claim 12, wherein the temperature homogenizer is a unitary structure produced by casting and further, wherein the reactor is formed as an integral pan of the temperature homogenizer. 15. The fluid processor of claim 12, wherein the temperature homogenizer is enclosed by an insulation jacket. 16. A fluid processor comprising: a pump for drawing a fluid from a fluid source through a fluid inlet and pressurizing the fluid; a processor assembly comprising a fluid heater for heating the fluid from the pump; a process control system comprising: a flow splitter disposed between the pump and the processor assembly for diverting a portion of the fluid from the pump, a first flow restrictor for receiving the diverted fluid and directing the diverted fluid to the fluid inlet, a first pressure relief valve disposed between the first flow restrictor and the flow splitter, a second pressure relief valve disposed between an upstream side of the processor assembly and a downstream side of the flow splitter and a second flow restrictor disposed downstream of the processor assembly, wherein the flow splitter, flaw restrictors and pressure relief valves are constructed and arranged to coact with each other to control the pressure and flow rate of the fluid in the fluid processor. 17. The fluid processor of claim 16, wherein the process control system maintains the pressure of the fluid in the processor assembly at least about the saturation point of the fluid at a predetermined temperature. 18. The fluid processor of claim 16, wherein the flow splitter is a filtration device. 19. The fluid processor of claim 16, wherein the flow splitter is a reverse osmosis device. 20. The fluid processor of claim 16, wherein at least one flow restrictor is a fixed setting flow restrictor. 21. The fluid processor of claim 20, wherein the fixed setting flow restrictor is a fixed length capillary tube. 22. The fluid processor of claim 16, wherein at least one flow restrictor is an adjustable setting flow restrictor. 23. The fluid processor of claim 22, wherein the adjustable setting flow restrictor is a metering valve. 24. The fluid processor of claim 16, wherein at least one pressure relief valve is a spring-loaded adjustable pressure relief valve. 25. The fluid processor of claim 16, wherein the fluid processor further comprises a check valve disposed upstream of the processor assembly. 26. The fluid processor of claim 16, further comprising a treatment assembly comprising a prefilter disposed upstream of the processor assembly. 27. The fluid processor of claim 26, wherein the treatment assembly further comprises a reverse osmosis device disposed downstream of the prefilter. 28. The fluid processor of claim 26, wherein the treatment assembly further comprises a RODI apparatus disposed between the prefilter and the processor assembly, the RODI apparatus comprising a reverse osmosis device and an ion exchange device. 29. The fluid processor of claim 26, wherein the treatment assembly further comprises a RODI apparatus disposed downstream of the processor assembly, the RODI apparatus comprising a reverse osmosis device and an ion exchange device. 30. The fluid processor of claim 26, wherein the treatment assembly further comprises a RODI apparatus comprising: an ion exchange device disposed between the prefilter and processor assembly; and a reverse osmosis device disposed downstream of the processor assembly. 31. The fluid processor of claim 16, wherein fluid processor processes feed water to produce sterile water for injection. 32. The fluid processor of claim 16, further comprising: a temperature sensor for measuring the temperature of the fluid in the processor assembly; and a controller for controlling the fluid heater. 33. The fluid processor of claim 16, further comprising an electronic control system for controlling the fluid processor, the electronic control system comprising: a touch screen interface for providing readouts and operator input; and a programmable logic controller for managing the electronic control system, the programmable logic controller comprising a main control circuit and a central processing unit and further, wherein the programmable logic controller is interfaced with a temperature sensor, a pressure transducer, a controller for controlling the fluid heater, and a pump controller. 34. The fluid processor of claim 33, wherein the programmable logic controller is further interfaced with an endotoxin sensor having a signal conditioner, a flow rate meter having a flow sensor, and a conductivity meter having a conductivity cell. 35. The fluid processor of claim 34, wherein the endotoxin sensor, flow sensor and conductivity cell are disposed downstream of the processor assembly along a discharge line. 36. The fluid processor of claim 34, wherein the flow sensor and conductivity cell are disposed downstream of the processor assembly along a divert line. 37. The fluid processor of claim 34, wherein the endotoxin sensor, flow sensor and conductivity cell are disposed along a divert line. 38. The fluid processor of claim 34, wherein the endotoxin sensor is disposed along a sampling line. 39. The fluid processor of claim 16, wherein the heater is a hot gas heater and further, wherein the processor assembly further comprises: a helical coil tube-in-tube heat exchanger for exchanging heat between a process fluid and a product fluid; and a helical coil-shaped reactor nested within the heat exchanger. 40. The fluid processor of claim 39, wherein the processor assembly further comprises an insulated duct having a hot gas inlet at one end and a vent at the other end and further, wherein the heat exchanger is disposed within the insulated duct. 41. The fluid processor of claim 39, wherein the processor assembly further comprises a hot gas tube and an insulated enclosure having an opening at the top and further, wherein the heat exchanger is disposed within the enclosure and the reactor is disposed within the hot gas tube and further, wherein the hot gas tube is nested within the heat exchanger. 42. The fluid processor of claim 16, wherein the processor assembly further comprises a multiplicity of heat exchangers for exchanging heat between a process fluid and a product fluid. 43. The fluid processor of claim 42, wherein at least two heat exchangers are connected together in parallel. 44. The fluid processor of claim 42, wherein at least two heat exchangers are connected together in series. 45. The fluid processor of claim 42, wherein at least one heat exchanger is a tube-in-tube type heat exchanger. 46. The fluid processor of claim 42, wherein at least one heat exchanger is a helical coil tube-in-tube type heat exchanger. 47. The fluid processor of claim 42, wherein at least one heat exchanger is a rope rug coil tube-in-tube heat exchanger. 48. The fluid processor of claim 16 further comprising: a temperature sensor for measuring the temperature of the fluid upstream of the processor assembly. 49. The fluid processor of claim 16 further comprising: a temperature sensor for measuring the temperature of the fluid downstream of the processor assembly. 50. The fluid processor of claim 16 further comprising: a pressure sensor for measuring the pressure of the fluid upstream of the processor assembly. 51. The fluid processor of claim 16 further comprising: a pressure sensor for measuring the pressure of the fluid downstream of the processor assembly. 52. The fluid processor of claim 16, wherein the process control system further comprises a third pressure relief valve disposed downstream of the second flow restrictor.

Details for Patent 7,122,149

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		2022-07-12