Risk-managed, single-use, pre-calibrated, pre-sterilized sensors for use in bio-processing applications

• US 9,575,087 B2
• Filed: 08/12/2013
• Issued: 02/21/2017
• Est. Priority Date: 09/06/2012
• 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): WILLIAMS, HEZRON
• Assistant Examiner(s): Kidanu, Gedeon M
• Application Number:
  US13/964,833
• Publication Number:
  US 20140060161A1
• Time in Patent Office: 1,289 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: G01F 1/00 Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow measuring a proportion of the volume flow G01F5/00
• CPC Class Codes: G01N 27/10 Investigation or analysis specially adapted for controlling or monitoring operations or for signalling
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 37/00 Details not covered by any other group of this subclass
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

Single-use, pre-sterilized, and pre-calibrated, pre-validated 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 or in a barcode printed on the sensor. These sensors may be utilized 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. The sensors exhibit both their primary sensing function such as conductivity, pH level, dissolved oxygen, pressure or temperature, as well as at least one secondary sensing function of risk management or risk mitigation.

Claims

1. A single-use bio-solution processing sensor, comprising:

a fluid conduit through which a biopharmaceutical solution flows during use of the sensor;

an on-sensor memory device;

a usage counter associated with the sensor;

said usage counter includes a motion detector, the motion detector detects vibration corresponding to solution flow through the fluid conduit, and the memory device analyzes the vibration and designates the vibration as a counted sensor use event, whereupon the counted sensor use event is stored on the memory device and accumulates with prior or subsequent use events until a maximum use total stored on the memory device is attained; and

the motion detector is an accelerometer that operates as a flow meter, whereby when a relatively non-compressible fluid flows through the fluid conduit a first accelerometer output is generated, and when a compressible fluid flows through the fluid conduit a second accelerometer output is generated, resulting in a differential between the first and second accelerometer outputs, thereby indicating an end to a cycle of a manifold within which the sensor is included.

2. The sensor according to claim 1, wherein said vibration is recognized as a counted sensor use only after having been maintained for a pre-selected time interval.

3. The sensor according to claim 1, wherein said memory device has sensor-specific serialization and traceability data retrievable from the memory device.

4. The sensor according to claim 1, further including a first input provision to disable the sensor once the maximum use total is attained and a second input provision to allow continued sensor use even after the maximum use total is attained.

5. The sensor according to claim 1, wherein said memory device analyzes the length of time that the detector detects vibration and stores the length of time as an amount of use time between said use threshold event and said end point of usage is stored in the memory device as a use amount that accumulates until the maximum use time total is attained.

6. The sensor according to claim 1, wherein the sensor includes an electrode at least partially positioned in said fluid conduit, and said electrode collects parameter data of the biopharmaceutical solution within the fluid conduit, the parameter data being used to calculate a solution property selected from the group consisting of electrical conductivity, pressure, temperature, pH, dissolved oxygen, turbidity, and combinations thereof.

7. The sensor according to claim 1, wherein said on-sensor memory device has a time event feature, said time event feature is initialized by achievement of a threshold event and is recognized as a counted sensor use after having been maintained for a pre-selected time interval, whereupon the counted sensor use is stored on the memory device and accumulates with prior or subsequent uses until a maximum use total is attained;

and said time event feature and usage counter utilizing motion detection electronically interact to confirm total usage.

8. The sensor according to claim 1, further including a first input provision to disable the sensor once the maximum use total is attained.

9. The sensor according to claim 1, further including a second input provision to allow continued sensor use even after the maximum use total is attained.

10. The system according to claim 1, wherein said motion detector is an accelerometer on the base of the multiple-use interface.

11. The sensor according to claim 1, further including

an on-sensor thermal fuse that is readable for transmission of information to the sensor for storage on the memory device, the thermal fuse being set with a threshold autoclave temperature at which the fuse trips, and the thermal fuse is electronically interrogatable for fuse tripping prior to its use in solution processing, thereby indicating successful autoclaving.

12. The sensor according to claim 11, wherein the thermal fuse has a closed circuit status, as set, at which the fuse is closed prior to having been subjected to the threshold autoclave temperature and an open circuit status at which the fuse is open upon being subjected to the threshold autoclave temperature.

13. The sensor according to claim 1, wherein the on-sensor memory device has an as-manufactured stored pre-gamma radiation threshold voltage and an as-manufactured stored post-gamma radiation threshold voltage greater in magnitude than a pre-gamma threshold radiation voltage, further including

an on-sensor gamma-responsive component that informs the on-sensor memory device of voltage due to gamma radiation exposure, and exposure of the gamma sensor to gamma radiation shifts the voltage in a repeatable manner to indicate the sensor has been sterilized with gamma radiation.

14. The sensor in accordance with claim 13, wherein the on-sensor gamma-responsive component is a bipolar transistor.

15. The sensor in accordance with claim 13, wherein the on-sensor gamma-responsive component is a gamma-exposure meter associated with a FRAM chip having a factory-specified supply voltage requirement at which the FRAM chip functionality is restored with gamma radiation.

16. The sensor according to claim 15, wherein the pre-gamma radiation threshold voltage correlates to a zero kGy gamma radiation level, and the post-gamma irradiation threshold voltage correlates to a positive kGy gamma radiation level substantially corresponding to a gamma radiation exposure level for said sensor.

17. The sensor according to claim 16, wherein the average pre-gamma irradiation threshold voltage is 4.25+/−

0.05 volts, and the average post-gamma irradiation threshold voltage is 4.75+/−

0.05 volts, and wherein 4.25 volts correlates with zero kGy and 4.75 volts correlates with 35+/−

5% kGy.

18. A dockable sensor system comprising a combination of a multiple-use user interface, a single-use bio-solution processing sensor module and a motion detector:

the multiple-use interface having an electronic reception and transmission function and comprising a base having a docking location;

the single-use sensor module comprising;

a fluid conduit through which a biopharmaceutical solution flows during use of the sensor;

an on-sensor memory device;

a usage counter associated with the sensor;

said usage counter includes a motion detector, the motion detector detects vibration corresponding to changes in solution flow through the fluid conduit, and the memory device analyzes the vibration and designates the vibration as a counted sensor use event, whereupon the counted sensor use event is stored on the memory device and accumulates with prior or subsequent use events until a maximum use total stored on the memory device is attained; and

the motion detector is an accelerometer that operates as a flow meter, whereby when a relatively non-compressible fluid flows through the fluid conduit a first accelerometer output is generated, and when a compressible fluid flows through the fluid conduit a second accelerometer output is generated, resulting in a differential between the first and second accelerometer outputs, thereby indicating an end to a cycle of a manifold within which the sensor is included.

19. The system according to claim 18, wherein said motion detector is an accelerometer on the base of the multiple-use interface.

20. The system according to claim 18, wherein said vibration is recognized as a counted sensor use event after having been maintained for a preselected time interval.

21. The system according to claim 18, wherein said usage counter utilizes a self-heating thermistor in operative communication with the fluid conduit and the memory device, and a counted sensor event occurs when the thermistor detects a change in temperature reading when compared with its temperature reading for air.

22. The sensor according to claim 18, wherein said on-sensor memory device has a time event feature, said time event feature is initialized by achievement of a threshold event and is recognized as a counted sensor use after having been maintained for a pre-selected time interval, whereupon the counted sensor use is stored on the memory device and accumulates with prior or subsequent uses until a maximum use total is attained;

and said time event feature and usage counter utilizing motion detection electronically interact to confirm total usage.

23. The sensor according to claim 18, further including a first input provision to disable the sensor once the maximum use total is attained.

24. The sensor according to claim 18, further including a second input provision to allow continued sensor use even after the maximum use total is attained.