Single-use manifolds for automated, aseptic handling of solutions in bioprocessing applications

Patent metadata

Field	Value
Publication number	US-9700844-B2
Application number	US-201313769971-A
Country	US
Kind code	B2
Filing date	Feb 19, 2013
Priority date	Jun 14, 2002
Publication date	Jul 11, 2017
Grant date	Jul 11, 2017

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.

First claim

The invention claimed is:

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.

2. The system in accordance with claim 1 , wherein said control logic of the controller dictates the rate of flow of the biotechnology fluid.

3. The system in accordance with claim 2 , wherein said control logic of the controller determines the extent of filling of at least one of the single-use containers by processing data monitored by the system to achieve filling of the single-use container by volume, by weight, or by flow rate and filling time.

4. The system in accordance with claim 1 , wherein said control logic of the controller determines the extent of filling of at least one of the single-use containers by processing data monitored by the system to achieve filling of the single-use container by volume, by weight, or by flow rate and filling time.

5. The system in accordance with claim 1 , wherein said control logic is operable to activate flow of the biotechnology fluid and opens one of the remotely operable valves for a length of time needed to flow a selected volume or weight of biotechnology fluid into a single-use container associated with that remotely operable valve, and wherein said control logic is operable to activate flow of the biotechnology fluid and opens another of the remotely operable valves for a length of time needed to flow a selected volume or weight of biotechnology fluid into another valve single-use container until a user-selected number of single-use containers are filled.

6. The system in accordance with claim 1 , wherein said outlet end portion of the tubing has a plurality of serially arranged outlet passageways each having one of said aseptic connectors for operable connection with one of said single-use containers, and wherein one of said remotely operable valves controls passage of the biotechnology fluid from the tubing to the single-use container bag.

7. The system in accordance with claim 1 , wherein the disposable pressure sensor is positioned along said length of tubing such that the biotechnology fluid can flow therethrough at a location upstream of said outlet end portion.

8. The system in accordance with claim 1 , wherein said system is for tangential flow filtration, wherein one said single-use container is a process solution container and another said single-use container is a permeate collection container, wherein 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, and said disposable filter is 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 collected in said permeate collection container.

9. The system in accordance with claim 8 , wherein said inlet end portion is within said filtration flow-through section and in operative communication with said process solution single-use container, said filtration flow-through section further includes a recirculation length of tubing having one of said remotely operable valves between an exit port of said disposable filter and said process solution single-use container.

10. The system in accordance with claim 9 , wherein the disposable pressure sensor is positioned along said filtration flow-through section tubing such that the biotechnology fluid can flow therethrough at a location downstream of said disposable filter.

11. The system in accordance with claim 8 , wherein the disposable pressure sensor is positioned along said filtration flow-through section tubing such that the biotechnology fluid can flow therethrough at a location upstream of said disposable filter.

12. The system in accordance with claim 8 , wherein the disposable pressure sensor is positioned along said filtered fluid length of tubing such that the biotechnology fluid can flow therethrough at a location between said disposable filter and said permeate collection single-use container.

13. The system in accordance with claim 1 , wherein at least one of the single-use containers includes a shut-off clamp for its access port, and wherein said single-use container further includes a port that releases gas or pressure build-up from said container, an auxiliary access port, and a shut-off clamp for said access port and for said auxiliary access port.

14. The manifold system in accordance with claim 1 , wherein the container is a bag, and the remotely operable valve is a pinch valve that engages the outside surface of the length of tubing.

15. 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:
(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 outle

Assignees

• Parker Hannifin Corp

Inventors

• Schick Karl G

Classifications

• B01D61/22

  Controlling or regulating · CPC title

• B01D2311/06

  Specific process operations in the permeate stream · CPC title

• B01D2311/2649

  Filtration · CPC title

• G01N2030/8813

  biological materials · CPC title

• B01D61/20 Primary

  Accessories; Auxiliary operations · CPC title