Disposable, pre-calibrated, pre-validated sensors for use in bio-processing applications
First Claim
1. A method of manufacturing, pre-calibrating and pre-validating a particular disposable electrical conductivity sensing device for a bio-processing fluid, comprising:
- providing a conduit for directing a bio-processing fluid;
positioning an electrical conductivity sensor component and a memory component on the conduit such that said electrical conductivity sensor component electrically interacts with bio-processing fluid flowing through the conduit thereby providing an uncalibrated and unvalidated electrical conductivity sensing device;
running a calibration solution through the conduit, said calibration solution having a known electrical conductivity value;
measuring an electrical value of the electrical conductivity sensor component during said running of the calibration solution through the conduit in order to measure the electrical conductivity for the calibration solution as detected by the particular uncalibrated and unvalidated electrical conductivity sensing device, said electrical value being selected from current, voltage and combinations thereof;
calculating a cell constant for said particular uncalibrated and unvalidated electrical conductivity sensing device by mathematically combining said known conductivity value of the calibration solution with the measured conductivity value thereof;
storing the cell constant in the memory component on the particular sensing device in order to provide a particular pre-calibrated sensing device;
calculating a statistical performance value based on individual measurement performances of a plurality of said thus pre-calibrated sensing devices within a production batch of said thus pre-calibrated sensing devices; and
storing the statistical performance value in the memory component on the sensing device to provide a particular pre-calibrated, pre-validated 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. 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
7 Claims
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1. A method of manufacturing, pre-calibrating and pre-validating a particular 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 an electrical conductivity sensor component and a memory component on the conduit such that said electrical conductivity sensor component electrically interacts with bio-processing fluid flowing through the conduit thereby providing an uncalibrated and unvalidated electrical conductivity sensing device; running a calibration solution through the conduit, said calibration solution having a known electrical conductivity value; measuring an electrical value of the electrical conductivity sensor component during said running of the calibration solution through the conduit in order to measure the electrical conductivity for the calibration solution as detected by the particular uncalibrated and unvalidated electrical conductivity sensing device, said electrical value being selected from current, voltage and combinations thereof; calculating a cell constant for said particular uncalibrated and unvalidated electrical conductivity sensing device by mathematically combining said known conductivity value of the calibration solution with the measured conductivity value thereof; storing the cell constant in the memory component on the particular sensing device in order to provide a particular pre-calibrated sensing device; calculating a statistical performance value based on individual measurement performances of a plurality of said thus pre-calibrated sensing devices within a production batch of said thus pre-calibrated sensing devices; and storing the statistical performance value in the memory component on the sensing device to provide a particular pre-calibrated, pre-validated electrical conductivity sensing device. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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Specification