Disposable, pre-calibrated, pre-validated sensors for use in bio-processing applications

• US 8,506,162 B2
• Filed: 03/19/2009
• Issued: 08/13/2013
• Est. Priority Date: 12/05/2005
• Status: Active Grant

• Current Assignee: Parker Intangibles LLC (Parker-Hannifin Corporation)
• Original Assignee: Parker-Hannifin Corporation
• Inventors: Schick, Karl G., Uhen, David
• Primary Examiner(s): KAPLAN VERBITSKY, GAIL
• Application Number:
  US12/407,553
• Publication Number:
  US 20090180513A1
• Time in Patent Office: 1,608 Days
• Field of Search: 374/1, 374/2, 374/3, 374/29, 374/43, 374/44, 374/159, 374/163, 374/183, 374/184, 374/185, 374/100, 374/135, 374/141, 374/147, 374/148, 374/45, 374/56, 374/208, 702/27, 702/130, 702/179, 702/182, 702/19, 702/22, 702/23, 702/50, 702/55, 702/85, 702/127, 702/99, 600/309, 600/322, 600/345, 422/82.01, 422/82.02, 73/231, 73/232.1, 73/232.5, 73/234.1, 73/250.3, 73/250.1, 733/350.5, 736/49, 736/58, 736/61, 436/149, 436/150, 436/53, 324/439, 324/441, 324/691, 324/705, 324/717
• US Class Current: 374/141
• 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 0.100 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

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

a conduit for directing a bio-processing fluid;

a sensing portion, said sensing portion is composed of at least one electrode in electrical communication with bio-processing fluid during use of the apparatus for sensing electrical 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, said barcode contains calibration information including a sensor-specific cell constant that is a function of the specific sensor'"'"'s conductance;

said apparatus is made of disposable material suitable for single use of the apparatus; and

a user interface, said user interface is connectable with said sensing portion, drives a current through the sensing portion, accesses or retrieves the sensor-specific cell constant encoded by said barcode, and uses the cell constant to calculate the electrical conductivity of the bio-processing fluid.

2. The sensor of claim 1, wherein said barcode is a matrix barcode.

3. The sensor of claim 1, wherein said barcode calibration information further includes a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

4. The sensor of claim 1, wherein said sensing portion comprises a printed circuit board.

5. The sensor of claim 1, wherein said structure for measuring the temperature of the bio-processing fluid includes at least one thermistor.

6. The sensor of claim 1, wherein said at least one electrode is in contact with said bio-processing fluid during use of the apparatus.

7. The sensor of claim 1, 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.

8. The sensor of claim 1, wherein said barcode calibration information further includes a sensor-specific temperature offset factor that is a comparison between an uncalibrated temperature reading given by that specific sensor (Tsen) and a reference temperature (Tref).

9. The sensor of claim 8, wherein said barcode includes a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

10. The sensor of claim 1, wherein said conduit is an in-line component of a system for separation or purification of the bio-processing fluid.

11. The sensor of claim 1, wherein said barcode is a multidimensional barcode, said sensing portion has four electrode pins, and at least a portion of said conduit and said sensing portion is within a housing.

12. The sensor of claim 1, wherein said sensing portion also has a memory component.

13. The sensor of claim 12, wherein said memory component stores calibration information including a statistical performance value based on individual measurement performances of a plurality of said disposable sensors.

14. The sensor of claim 12, wherein said memory component is a non-volatile memory chip.

15. The sensor of claim 12, wherein said memory component stores or contains at least the same information as encoded by said barcode.

16. The sensor of claim 15, wherein said component stores or contains additional calibration information not encoded by said barcode.

17. The sensor of claim 12, wherein said memory component is a non-volatile memory chip.

18. The sensor of claim 17, wherein said non-volatile memory chip is an EEPROM.