Single-use manifolds for automated, aseptic handling of solutions in bioprocessing applications
First Claim
Patent Images
1. A manifold system for biotechnology uses, comprising:
- a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including;
(a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough,(b) a plurality of single-use containers, each container having an access port, and(c) at least one aseptic connector that operatively connects said length of tubing with each said single-use container;
a plurality of valves operable to engage said length of tubing, the valves being remotely operable valves;
a disposable filter positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet and portion;
at least one pre-sterilized, calibrated and disposable electrical conductivity sensor adapted for single-time usage;
the electrical conductivity sensor senses the electrical conductivity of the biotechnology fluid within the tubing and has a memory component capable of storing data, the memory component including a sensor-specific temperature offset assigned to that specific sensor during calibration of the sensor, wherein said temperature offset was determined during manufacture employing a calibration solution, including determining the actual temperature (Tref) value of the calibration solution, using the specified pre-calibrated sensor to measure the temperature (Tsen) value of the calibration solution, and mathematically combining said Tref and said Tsen into said sensor specific temperature offset;
at least one disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location selected from the group consisting of upstream, downstream, both upstream and downstream of said disposable filter, and upstream of said outlet end portion; and
a controller which controls operation of said remotely operable valves, said controller having control logic which dictates the timing of opening and closing of said remotely operable valves.
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Accused Products
Abstract
Presteralized manifolds are provided which are designed for sterile packaging and single-use approaches. Disposable tubing and flexible-wall containers are assembled via aseptic connectors. These manifolds are adapted to interact with other equipment which can be operated by a controller which provides automated and accurate delivery of biotechnology fluid. The manifold also can be used in conjunction with one or more sensors such as pressure and conductivity sensors that interact with the controller or are connected to a separate user interface. An aseptic environment obtains avoiding or reducing cleaning and quality assurance procedures.
66 Citations
38 Claims
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1. A manifold system for biotechnology uses, comprising:
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a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including; (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use containers, each container having an access port, and (c) at least one aseptic connector that operatively connects said length of tubing with each said single-use container; a plurality of valves operable to engage said length of tubing, the valves being remotely operable valves; a disposable filter positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet and portion; at least one pre-sterilized, calibrated and disposable electrical conductivity sensor adapted for single-time usage; the electrical conductivity sensor senses the electrical conductivity of the biotechnology fluid within the tubing and has a memory component capable of storing data, the memory component including a sensor-specific temperature offset assigned to that specific sensor during calibration of the sensor, wherein said temperature offset was determined during manufacture employing a calibration solution, including determining the actual temperature (Tref) value of the calibration solution, using the specified pre-calibrated sensor to measure the temperature (Tsen) value of the calibration solution, and mathematically combining said Tref and said Tsen into said sensor specific temperature offset; at least one disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location selected from the group consisting of upstream, downstream, both upstream and downstream of said disposable filter, and upstream of said outlet end portion; and a controller which controls operation of said remotely operable valves, said controller having control logic which dictates the timing of opening and closing of said remotely operable valves. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A manifold system for biotechnology uses, comprising:
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a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including; (d) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (e) at least one single-use container having an access port, and (f) at least one aseptic connector that operatively connects said length of tubing with said at least one single-use container; a plurality of valves operable to engage said length of tubing, the valves being remotely operable valves; a disposable filter positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet and portion; at least one pre-sterilized, calibrated and disposable electrical conductivity sensor adapted for single-time usage; the electrical conductivity sensor senses the electrical conductivity of the biotechnology fluid within the tubing and has a memory component capable of storing data, the memory component including a sensor-specific temperature offset assigned to that specific sensor during calibration of the sensor, wherein said temperature offset was determined during manufacture employing a calibration solution, including determining the actual temperature (Tref) value of the calibration solution, using the specified pre-calibrated sensor to measure the temperature (Tsen) value of the calibration solution, and mathematically combining said Tref and said Tsen into said sensor specific temperature offset; at least one disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location selected from the group consisting of upstream, downstream, both upstream and downstream of said disposable filter, and upstream of said outlet end portion; and a controller which controls operation of a plurality of said remotely operable valves, said controller having control logic which dictates the timing and the extent of opening and closing of a plurality of said remotely operable valves. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22)
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23. A system for biotechnology uses, wherein said system is for tangential flow filtration, comprising:
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a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including; (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use containers, each having an access port, one said single-use container is a process solution container and another said single-use container is a permeate collection container, (c) said tubing includes at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution container, said filtered fluid section includes said permeate collection container, (d) an aseptic connector of said single-use container, (e) a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution container is filtered through said disposable filter and is collected in said permeate collection container (f) at least one pre-sterilized, calibrated and disposable electrical conductivity sensor adapted for single-time usage, the electrical conductivity sensor senses the electrical conductivity of the biotechnology fluid within the tubing and has a memory component capable of storing data, the memory component including a sensor-specific temperature offset assigned to that specific sensor during calibration of the sensor, wherein said temperature offset was determined during manufacture employing a calibration solution, including determining the actual temperature (Tref) value of the calibration solution, using the specified pre-calibrated sensor to measure the temperature (Tsen) value of the calibration solution, and mathematically combining said Tref and said Tsen into said sensor specific temperature offset, and (g) at least one disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location selected from the group consisting of upstream, downstream ah, both upstream and downstream of said disposable filter, and upstream of said outlet end portion; and at least one remotely operable valve, said remotely operable valve engaging said length of tubing and independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing. - View Dependent Claims (24, 25, 26, 27, 28, 29)
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30. A manifold and flow imparting system for biotechnology uses, wherein said system is for tangential flow filtration, comprising:
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a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including; (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use containers, each having an access port, one said single-use container is a process solution container and another said single-use container is a permeate collection container, (c) said tubing includes at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution container, said filtered fluid section includes said permeate collection container, (d) an aseptic connector of said single-use container, and (e) a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution container can be filtered through said disposable filter and can be collected in said permeate collection container, (f) at least one pre-sterilized, calibrated and disposable electrical conductivity sensor adapted for single-time usage, the electrical conductivity sensor senses the electrical conductivity of the biotechnology fluid within the tubing and has a memory component capable of storing data, the memory component including a sensor-specific temperature offset assigned to that specific sensor during calibration of the sensor, wherein said temperature offset was determined during manufacture employing a calibration solution, including determining the actual temperature (Tref) value of the calibration solution, using the specified pre-calibrated sensor to measure the temperature (Tsen) value of the calibration solution, and mathematically combining said Tref and said Tsen into said sensor specific temperature offset, (g) at least one disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location selected from the group consisting of upstream, downstream, both upstream and downstream of said disposable filter, and upstream of said outlet end portion, and (h) at least one remotely operable valve, the remotely operable valve located so as to engage said length of tubing and independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing; and a flow imparting unit at a selected location upstream of said disposable filter. - View Dependent Claims (31)
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32. An automated manifold and flow imparting system for biotechnology uses, wherein said system is for tangential flow filtration, comprising:
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a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including; (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use containers, each having an access port, one said single-use container is a process solution container and another said single-use container is a permeate collection container, (c) said tubing includes at least two sections including a filtration flow-through section and a filtered fluid section, said filtration flow-through section includes said process solution container, said filtered fluid section includes said permeate collection container, (d) a plurality of aseptic connectors of at least one of said single-use containers, (e) a disposable filter between said filtration flow-through section and said filtered fluid section, whereby fluid from said process solution container is filtered through said disposable filter and is collected in said permeate collection container, (f) at least one pre-sterilized, calibrated and disposable electrical conductivity sensor adapted for single-time usage, the electrical conductivity sensor senses the electrical conductivity of the biotechnology fluid within the tubing and has a memory component capable of storing data, the memory component including a sensor-specific temperature offset assigned to that specific sensor during calibration of the sensor, wherein said temperature offset was determined during manufacture employing a calibration solution, including determining the actual temperature (Tref) value of the calibration solution, using the specified pre-calibrated sensor to measure the temperature (Tsen) value of the calibration solution, and mathematically combining said Tref and said Tsen into said sensor specific temperature offset, (g) at least one disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location selected from the group consisting of upstream, downstream, both upstream and downstream of said disposable filter, and upstream of said outlet end portion, and (h) at least one remotely operable valve, the remotely operable valve engageable with said length of tubing; a flow imparting unit at a selected location upstream of said disposable filter; and a controller operatively controlling said flow imparting unit and said valve, said controller having control logic which dictates timing and extent of opening and closing of said remotely operable valve and dictates the rate of flow imparted by said flow imparting unit. - View Dependent Claims (33, 34, 35, 36, 37, 38)
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Specification