Disposable, pre-calibrated, pre-validated sensors for use in bio-processing applications
First Claim
1. A method of manufacturing a disposable electrical 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 disposable electrical conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit;
running a calibration solution through the conduit, said calibration solution having a known electrical conductivity value;
measuring an electrical value of the sensor component during said running of the calibration solution through the conduit in order to provide a measured electrical conductivity for the calibration solution as detected by the particular electrical conductivity sensing device, said electrical value being selected from current, voltage and combinations thereof;
calculating a cell constant for said particular disposable electrical conductivity sensing device by mathematically combining said known electrical conductivity value of the calibration solution with the measured electrical conductivity value thereof;
calculating a statistical performance value based on individual measurement performances of a plurality of said pre-calibrated electrical conductivity sensing devices within a sensor production batch; and
labeling said disposable electrical conductivity sensing device with the cell constant and statistical performance value for that particular device, wherein said labeling comprises a barcode, said barcode being etched or printed on said disposable electrical conductivity sensing device.
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Accused Products
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.
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Citations
17 Claims
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1. A method of manufacturing a disposable electrical conductivity sensing device for a bio-processing fluid, comprising:
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providing a conduit for directing a bio-processing fluid; positioning a sensor component with respect to the disposable electrical conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit; running a calibration solution through the conduit, said calibration solution having a known electrical conductivity value; measuring an electrical value of the sensor component during said running of the calibration solution through the conduit in order to provide a measured electrical conductivity for the calibration solution as detected by the particular electrical conductivity sensing device, said electrical value being selected from current, voltage and combinations thereof; calculating a cell constant for said particular disposable electrical conductivity sensing device by mathematically combining said known electrical conductivity value of the calibration solution with the measured electrical conductivity value thereof; calculating a statistical performance value based on individual measurement performances of a plurality of said pre-calibrated electrical conductivity sensing devices within a sensor production batch; and labeling said disposable electrical conductivity sensing device with the cell constant and statistical performance value for that particular device, wherein said labeling comprises a barcode, said barcode being etched or printed on said disposable electrical conductivity sensing device. - View Dependent Claims (2, 3, 4, 5)
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6. A method of measuring the electrical conductivity of a bio-processing fluid, comprising:
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providing a particular disposable electrical conductivity 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 particular disposable electrical conductivity sensor assembly; passing a current through the particular disposable electrical conductivity 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 an electrical conductivity value that is indicative of a measured electrical conductivity of the bio-processing fluid; scanning a barcode associated with the particular electrical conductivity sensor; retrieving a cell constant for the particular electrical conductivity sensor from the information contained within the barcode of that particular electrical conductivity sensor; and calculating the actual electrical conductivity of the bio-processing fluid, said calculating comprising mathematically combining the measured electrical conductivity value with said cell constant. - View Dependent Claims (7, 8, 9, 10, 14, 15)
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11. A method of manufacturing a disposable sterilized, pre-validated, and pre-calibrated electrical conductivity sensor comprising:
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providing a conduit for directing a bio-processing fluid; positioning a sensor component on the disposable electrical conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit; calibrating and validating said sensor component while same is on the disposable electrical conductivity sensing device, said calibrating including; running a calibration solution through the conduit, said calibration solution having a known electrical conductivity value, measuring an electrical value of the sensor component during said running of the calibration solution through the conduit in order to provide a measured electrical conductivity for the calibration solution as detected by the particular disposable electrical conductivity sensing device, said electrical value being selected from current, voltage and combinations thereof, calculating a cell constant for said particular electrical conductivity sensing device by mathematically combining said known electrical conductivity value of the calibration solution with the measured electrical conductivity value thereof, and calculating a statistical performance value based on individual measurement performances of a plurality of said pre-calibrated electrical conductivity sensing devices within a sensor production batch; encoding information related to the calibrating and validating step in a barcode, said information including the cell constant for that particular electrical conductivity sensing device; enclosing said conduit and sensor component in a container suitable for storage or shipping; and sterilizing said conduit, sensor component, and container. - View Dependent Claims (12, 13, 16, 17)
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Specification