RISK-MANAGED, SINGLE-USE, PRE-CALIBRATED, PRE-STERILIZED SENSORS FOR USE IN BIO-PROCESSING APPLICATIONS
First Claim
1. A single-use bio-solution processing sensor having usage counter capabilities, comprising:
- a fluid conduit through which biopharmaceutical solution flows during use of the sensor;
an on-sensor memory device;
a usage counter associated with the sensor; and
said usage counter utilizes motion detection corresponding to solution flow through the fluid conduit as a threshold event to designate 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.
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Accused Products
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.
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Citations
27 Claims
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1. A single-use bio-solution processing sensor having usage counter capabilities, comprising:
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a fluid conduit through which biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; a usage counter associated with the sensor; and said usage counter utilizes motion detection corresponding to solution flow through the fluid conduit as a threshold event to designate 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A single-use bio-solution processing sensor having usage counter capabilities, comprising:
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a fluid conduit through which biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; a usage counter associated with the sensor; and said usage counter utilizes pressure detection corresponding to solution flow through the fluid conduit as a threshold event to designate a counted sensor use event, the threshold event is a first pressure spike stored in the on-sensor memory device as a peak pressure along with a corresponding time event feature, the first pressure spike being the greatest pressure detected by the sensor during a given use, whereupon the stored counted sensor use event accumulates with prior or subsequent use events until a maximum use total stored on the memory device is attained. - View Dependent Claims (10, 11, 12, 13, 14)
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15. A single-use bio-solution processing sensor having usage counter capabilities, comprising:
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a fluid conduit through which biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; an on-sensor thermistor; a usage counter associated with the sensor; and said usage counter utilizes temperature detection by the thermistor of bio-solution flow through the fluid conduit as a threshold event to designate a counted sensor use event, the threshold event is a recognition of a differential between the thermistor detecting flowing liquid and the thermistor detecting air temperature, resulting in the threshold event to designate a counted sensor event, whereupon the stored counted sensor use event accumulates with prior or subsequent use events until a maximum use total stored on the memory device is attained. - View Dependent Claims (16)
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17. A single-use bio-solution sensor having gamma radiation exposure reporting capabilities, comprising:
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a fluid conduit through which biopharmaceutical solution flows during use of the sensor; an on-sensor memory device that maintains function under gamma radiation; 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; and 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. - View Dependent Claims (18, 19, 20, 21)
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22. A single-use bio-solution sensor having autoclave temperature exposure reporting capabilities, comprising:
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a fluid conduit through which biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; 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; the thermal fuse is electronically interrogatable for fuse tripping prior to its use in solution processing, thereby indicating successful autoclaving. - View Dependent Claims (23)
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24. A dockable sensor system comprising the combination of a multiple-use user interface, a single-use bio-solution processing sensor module and a motion detector:
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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 biopharmaceutical solution flows during use of the sensor; an on-sensor memory device; a usage counter associated with the sensor; and said usage counter detects changes in solution flow through the fluid conduit as a threshold event to designate 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. - View Dependent Claims (25, 26, 27)
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Specification