Apparatus and method for continuous depyrogenation and production of sterile water for injection
First Claim
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;
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 control valve are constructed and arranged to coact with each other to control the pressure and flow rate of the fluid in the fluid processor.
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Accused Products
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.
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Citations
72 Claims
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1. A fluid processor comprising:
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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;
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 control valve are constructed and arranged to coact with each other to control the pressure and flow rate of the fluid in the fluid processor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. A method for processing a fluid in a fluid processor, the method comprising:
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drawing a fluid from a fluid source through a fluid inlet;
pressurizing the fluid from the fluid source;
diverting a portion of pressurized fluid to the fluid inlet with a flow splitter to form a recirculating loop;
controlling the flow rate and pressure of the fluid in the recirculating loop using a first flow restrictor and a pressure relief valve;
processing the fluid in a processor assembly applying a backpressure to the fluid in the fluid processor using a second flow restrictor. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
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65. A compact processor assembly suitable for use in a fluid processor, the processor assembly comprising:
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at least one helical coil tube-in-tube heat exchanger for counter-currently exchanging heat between a process fluid and a product fluid, wherein the process fluid flows through an annular side of the heat exchanger and the product fluid flows through a tube side of the heat exchanger;
a reactor nested within the heat exchanger for converting the process fluid into a product fluid by heating;
a heater nested within the heat exchanger for heating the reactor; and
- View Dependent Claims (66, 67, 68, 70, 71, 72)
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69. A compact processor assembly suitable for use in a fluid processor, the processor assembly comprising:
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at least one helical coil tube-in-tube heat exchanger for counter-currently exchanging heat between a process fluid and a product fluid, wherein the process fluid flows through an annular side of the heat exchanger and the product fluid flows through a tube side of the heat exchanger;
a reactor nested within the heat exchanger for converting the process fluid into a product fluid by cooling;
a cooler nested within the heat exchanger for cooling the reactor; and
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Specification