DISPOSABLE, PRE-CALIBRATED, PRE-VALIDATED SENSORS FOR USE IN BIO-PROCESSING APPLICATIONS

• US 20070255527A1
• Filed: 04/27/2007
• Published: 11/01/2007
• Est. Priority Date: 12/05/2005
• Status: Active Grant

• Current Assignee: Parker Intangibles LLC (Parker-Hannifin Corporation)
• Original Assignee: SenCal, LLC
• Inventors: Uhen, David, Schick, Karl
• Granted Patent: US 7,788,047 B2
• Time in Patent Office: Days
• US Class Current: 702/179
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: G01N 27/10 Investigation or analysis specially adapted for controlling or monitoring operations or for signalling

Abstract

Disposable, pre-sterilized, and pre-calibrated, pre-validated conductivity sensors are provided. These sensors are designed to store sensor-specific information, such as calibration and production information, in a non-volatile memory chip on the sensor on in a barcode printed on the sensor The sensors are calibrated using 0100 molar potassium chloride (KCl) solutions at 25 degrees Celsius. These sensors may be utilize with in-line systems, closed fluid circuits, bioprocessing systems, or systems which require an aseptic environment while avoiding or reducing cleaning procedures and quality assurance variances.

Claims

6. A method of measuring the conductivity of a bio-processing fluid, comprising:

providing a disposable sensor assembly having a sensor component, a memory component and a conduit for directing a bio-processing fluid for electrical interaction with the bio-processing fluid flowing through the conduit;

running a bio-processing fluid through the conduit of the sensor assembly;

passing a current through the sensor component during said running of the bio-processing fluid through the conduit and measuring a resulting change in an electrical value across the sensor component, said change in electrical value being a conductivity value that is indicative of a measured conductivity of the bio-processing fluid;

scanning a barcode;

retrieving from the information contained within the barcode a constant; and

calculating the actual conductivity of the bio-processing fluid, said calculating comprising mathematically combining the measured conductivity value with said constant.

7. The method according to claim 6 further comprising:

measuring the temperature value of the bio-processing fluid running through the conduit;

retrieving from the information contained within the barcode a temperature offset; and

calculating the actual temperature of the bio-processing fluid, said calculating comprising of mathematically combining the measured temperature value with said temperature offset.

8. The method according to claim 6, wherein said calculating of the actual conductivity comprises mathematically combining said calculated actual temperature with said measured conductivity value and with said constant.

9. The method according to claim 6, wherein said mathematically combining includes multiplying the measured conductivity value by said constant.

10. The method according to claim 7, wherein said mathematically combining includes dividing the measured conductivity value by said constant.

11. A disposable sensor for measuring the conductivity of a bio-processing fluid, comprising:

a conduit for directing a bio-processing fluid;

a sensing portion, said sensing portion being arranged for sensing conductivity of bio-processing fluid passing through said conduit, said sensing portion having a structure for measuring the temperature;

a barcode printed or etched on the disposable sensor; and

said apparatus is made of inexpensive disposable material suitable for single use of the apparatus.

1. A method of manufacturing a disposable conductivity sensing device for a bio-processing fluid, comprising:

providing a conduit for directing a bio-processing fluid;

positioning a sensor component with respect to the conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit;

running a calibration fluid through the conduit, said calibration fluid having a known conductivity value;

measuring an electrical value of the sensory component during said running of the calibration fluid through the conduit in order to measure the conductivity for the calibration fluid as detected by the particular sensing device, said electrical value being selected from current, voltage and combinations thereof;

calculating a cell constant for said particular sensing device by mathematically combining said known conductivity value of the calibration fluid with the measured conductivity value thereof;

calculating a statistical performance value based on individual measurement performances of a plurality of said pre-calibrated sensing devices within a sensor production batch; and

labeling said sensing device with the cell constant and statistical performance value, wherein said labeling comprises of a barcode, said barcode being etched or printed on said sensing device.

2. The method of claim 1 further comprising:

determining the actual temperature value of the calibration fluid;

utilizing the sensing device to measure the temperature value of the calibration fluid;

calculating a temperature offset for said particular sensing device by mathematically combining said actual temperature value with the measured temperature value thereof; and

wherein the labeling step includes labeling said sensing device with temperature offset.

3. The method of claim 1 further comprising:

producing a production lot, said production lot being comprised of at least one or more sensing devices;

analyzing at least one or more sensing devices to determine statistical information about the production lot; and

wherein the labeling step includes labeling each sensing device in the production lot with the statistical information.

4. The method of claim 1 further comprising:

wherein said labeling of the statistical performance value in the memory component on the sensing device provides an “

out-of-box”

variance value.

5. The method of claim 4, further including labeling each sensing device with calibration information associated with the sensing device selected from the group consisting of a production lot number, statistical data associated with the production lot, a fluid conduit size, a unique serial number of the sensing device, a manufacturing date, a calibration date, a temperature offset, type of fluid used for calibration, temperature of the fluid used during calibration, said “

out-of-box”

variance value, and combinations thereof, wherein said labeling comprises said barcode.

12. The sensor of claim 11, wherein said barcode is a matrix barcode.

13. The sensor of claim 11, wherein said barcode contains calibration information including a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

14. The sensor of claim 11, wherein said sensing portion comprises a printed circuit board.

15. The sensor of claim 11, wherein said structure for measuring the temperature of the bio-processing fluid includes at least one thermistor.

16. The sensor of claim 11, wherein said sensing portion is composed of at least one electrode being arranged such that same is in contact with said bio-processing fluid during use of the apparatus.

17. The sensor of claim 16, wherein said sensing portion is composed of four electrodes being arranged such that said electrodes are in contact with said bio-processing fluid during use of the apparatus.

18. The sensor of claim 11, further comprising a user interface, said user interface being connectable with said sensing portion.

19. The sensor of claim 18, wherein said user interface drives a current through the sensing portion, and said user interface is able to calculate the conductivity of the bio-processing fluid.

20. The sensor of claim 18, wherein said user interface has the ability to access or retrieve the data encoded by said barcode.

21. The sensor of claim 11, wherein said barcode is a multidimensional barcode, said barcode being able to encode calibration data, said sensing portion having four electrode pins, and said electrode pins being arranged such that they are in contact with bio-processing fluid passing through said conduit, at least a portion of said conduit and said sensing portion being arranged within a impermeable housing.

22. The sensor of claim 11, wherein said sensing portion also has a memory component.

23. The sensor of claim 22, wherein said memory component stores calibration information including a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

24. The sensor of claim 22, wherein said memory component is a non-volatile memory chip.

25. The sensor of claim 22, wherein said memory component stores or contains at least the same information as encoded by said barcode.

26. The sensor of claim 25, wherein said component stores or contains additional calibration information not encoded by said barcode.

27. A user interface for connecting to disposable sensor, comprising:

hardware input and output connections for connecting to a barcode scanner;

hardware input and output connections for connecting to a disposable sensor, said sensor when activated returns analog signals through said hardware connections to the user;

software for interpreting said analog signals;

software for decoding barcodes read by said barcode scanner;

memory for storing said software for interpreting, software for decoding, and information decoded by the software for decoding barcodes.

27-1. The user interface of claim 26 further comprising:

a display for displaying information related to said analog signals return from said disposable sensor.

28. A method of manufacturing a sterilized, pre-validated, and pre-calibrated sensor comprising:

providing a conduit for directing a bio-processing fluid;

positioning a sensor component on conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit;

calibrating and validating said sensor component;

encoding information related to the calibrating and validating step in a barcode;

enclosing said conduit and sensor component in container suitable for storage or shipping; and

sterilizing said conduit, sensor component, and container.

29. The method of claim 28, wherein the positioning step includes positioning a memory component on the conductivity sensing device and the method further comprising the step of:

storing information related to the calibrating and validating step in a memory component.

30. The method of claim 28, further comprising the steps of:

after the sterilization step, removing the conduit and sensing component from the container;

reading the barcode via a barcode scanning device;

storing the information retrieved from the barcode in a memory of a computer or user interface;

connecting said conduit to a in-line system, closed fluid circuit, bioprocessing system, or any system in which fluid is passed through the conduit; and

connecting said sensor component to said computer or user interface.