# US 2022/0032301 A1 · System and Method for a Pharmaceutical Product

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- Number: US 2022/0032301 A1
- Document ID: US20220032301A1
- Status: Published application
- Kind: A1
- Application number: 17/277,046
- Filed: 2019-09-27
- Published: 2022-02-03
- Earliest claimed: 2018-09-27
- Assignees: Cytiva Sweden AB
- Applicants: Cytiva Sweden AB
- Inventors: Klaus Gebauer; Markus Pitkanen
- Web page: https://patentgrep.com/patent/US20220032301A1

## CPC

- B01L 3/502738: {characterised by integrated valves (throttle valves in microfluidic sample containers B01L3/502746)}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 3/502746: {characterised by the means for controlling flow resistance, e.g. flow controllers, baffles or throttle valves}
- B01L 2200/028: Modular arrangements
- B01L 2200/0689: Sealing
- B01L 2300/021: Identification, e.g. bar codes
- B01L 2300/022: Transponder chips
- B01L 2400/0481: squeezing of channels or chambers
- B01L 2400/0487: fluid pressure, pneumatics
- B01L 2400/0638: membrane valves, flap valves
- B01L 2400/0655: pinch valves
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

The present disclosure relates to a biological fluid processing system and method. The system comprises a fluid processing device comprising at least one fluid path, a pump for providing a pressure in the at least one fluid path, a valve arranged along said fluid path and a first actuator arranged to control the valve to assume a desired opening state of said fluid path. The biological fluid processing system comprises further a processing interface comprising a pump drive for driving the pump of the fluid processing device, and a processing control element comprising a pump control system arranged to control at least the pump drive and a valve control system arranged to control the first actuator. The system is modular. The fluid processing device is comprised in a fluid processing device module having a predetermined fluid processing device configuration. The processing interfaces have a predetermined processing interface configuration. The processing control element is arranged to receive information relating to the predetermined processing interface configuration of the processing interface module and/or the predetermined fluid processing device configuration of the fluid processing device module and control the at least one pump drive and/or the valve based on the received information relating to the predetermined fluid processing device configuration and the predetermined processing interface configuration.

## Claims

### Claim 1

A biological fluid processing system, comprising:
a fluid processing device comprising:
at least one fluid path;
a pump for providing a pressure in the at least one fluid path;
a valve arranged along said fluid path; and
a first actuator arranged to control the valve to assume a desired opening state of said fluid path;
a processing interface comprising a pump drive for driving the pump of the fluid processing device;
and
a processing control element comprising a pump control system arranged to control at least the pump drive and a valve control system arranged to control the first actuator;
characterised in that the system is modular and
the fluid processing device is comprised in a fluid processing device module having a predetermined fluid processing device configuration; and
the processing interfaces have predetermined processing interface configuration; and
the processing control element is arranged to
receive information relating to the predetermined processing interface configuration and/or the predetermined fluid processing device configuration of the fluid processing device module; and
control the at least one pump drive and/or the valve based on the received information relating to the predetermined fluid processing device configuration and/or the predetermined processing interface configuration.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the processing control element comprises or is connected to a user interface for input of information relating to the predetermined fluid processing device configuration and/or the predetermined processing interface configuration.

### Claim 3 (depends on 1)

The system according to of the claim 1, wherein the processing interfaces are comprised in a processing interface module having the predetermined processing interface configuration, wherein the processing control element is arranged to receive information relating to the predetermined processing interface configuration of the processing interface module.

### Claim 4 (depends on 1)

The system according to claim 1, wherein the processing control element comprises or is connected to a receiver arranged to receive information relating to the predetermined fluid processing device configuration and/or the predetermined processing interface configuration, wherein the received information may be communicated from an RFID tag associated to the processing interface module and/or fluid processing device module and/or wherein the received information may be obtained via machine-vision.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the received information comprises the identity of the fluid processing device module and/or the identity of the processing interface module.

### Claim 6 (depends on 1)

The system according to claim 1, wherein the fluid processing device module is provided with own structural support.

### Claim 7 (depends on 1)

The system according to a claim 1, wherein the first actuator is comprised in the valve.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the valve is a diaphragm valve.

### Claim 9 (depends on 1)

The system according to claim 1, wherein the first actuator is arranged to move a wetted part component of the valve to assume the desired opening state of the valve.

### Claim 10 (depends on 1)

The system according to claim 1, wherein the first actuator is designed such that displacement of a wall of a chamber of the first actuator affects the opening state of the fluid path.

### Claim 11 (depends on 10)

The system according to claim 10, wherein the valve and first actuator is formed by means of a valve seat and a flexible diaphragm, wherein the diaphragm is representing also the flexible wall in the chamber of the first actuator.

### Claim 12 (depends on 10)

The system according to claim 10, wherein the wall of the chamber is pneumatically controlled.

### Claim 13 (depends on 10)

The system according to claim 10, wherein the wall of the chamber is pneumatically controlled by applying fluid pressure to the wall of the chamber and modulating said fluid pressure.

### Claim 14 (depends on 1)

The system according to claim 1,
wherein the processing control element comprises a second actuator for control of the first actuator.

### Claim 15 (depends on 1)

The biological fluid processing system according to claim 1, wherein at least one of the fluid processing devices is a single-use technology product.

### Claim 16 (depends on 1)

A processing control element for use in a biological fluid processing system according to claim 1.

### Claim 17 (depends on 1)

A fluid processing device for use in a biological fluid processing system according to claim 1.

### Claim 18

A method for setting up a biological fluid processing system comprising
providing a fluid processing device comprising
at least one fluid path;
a pump for providing a pressure in the at least one fluid path;
a valve arranged along said fluid path; and
a first actuator arranged to control the valve to assume a desired opening state of said fluid path,
providing a processing control element,
connecting the fluid processing device to a processing interface and to the processing control element, and
controlling at least one pump drive for control of the pump and/or the valve based on received information relating to a predetermined fluid processing device configuration and a predetermined processing interface configuration.

### Claim 19 (depends on 18)

The method according to claim 18, further comprising steps of providing external fluid components and connecting said external fluid processing components to the fluid processing device prior to connecting the fluid processing device to the processing interface and/or processing control element.
