Disposable, pre-calibrated, pre-validated sensors for use in bio-processing applications
First Claim
1. A method of manufacturing a disposable conductivity sensing device for a bio-processing fluid, comprising:
- providing a conduit for directing a bio-processing fluid;
positioning a sensor component and a memory component on the conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit;
running a calibration fluid through the conduit, said calibration fluid having a known conductivity value;
measuring an electrical value of the sensory component during said running of the calibration fluid through the conduit in order to measure the conductivity for the calibration fluid as detected by the particular sensing device, said electrical value being selected from current, voltage and combinations thereof;
calculating a cell constant for said particular sensing device by mathematically combining said known conductivity value of the calibration fluid with the measured conductivity value thereof;
storing the cell constant in the memory component on the sensing device in order to provide a pre-calibrated sensing device;
calculating a statistical performance value based on individual measurement performances of a plurality of said pre-calibrated sensing devices within a sensor production batch; and
storing the statistical performance value in the memory component on the 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
21 Claims
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1. A method of manufacturing a disposable 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 and a memory component on the conductivity sensing device such that said sensor component electrically interacts with bio-processing fluid flowing through the conduit;
running a calibration fluid through the conduit, said calibration fluid having a known conductivity value;
measuring an electrical value of the sensory component during said running of the calibration fluid through the conduit in order to measure the conductivity for the calibration fluid as detected by the particular sensing device, said electrical value being selected from current, voltage and combinations thereof;
calculating a cell constant for said particular sensing device by mathematically combining said known conductivity value of the calibration fluid with the measured conductivity value thereof;
storing the cell constant in the memory component on the sensing device in order to provide a pre-calibrated sensing device;
calculating a statistical performance value based on individual measurement performances of a plurality of said pre-calibrated sensing devices within a sensor production batch; and
storing the statistical performance value in the memory component on the sensing device. - View Dependent Claims (2, 3, 4, 5)
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6. A method of measuring the conductivity of a bio-processing fluid, comprising:
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providing a disposable 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 sensor assembly;
passing a current through the 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 a conductivity value that is indicative of a measured conductivity of the bio-processing fluid;
retrieving a constant stored on the memory component of the sensor assembly; and
calculating the actual conductivity of the bio-processing fluid, said calculating comprising mathematically combining the measured conductivity value with said constant. - View Dependent Claims (7, 8, 9, 10)
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11. A disposable sensor for measuring the conductivity of a bio-processing fluid, comprising:
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a conduit for directing a bio-processing fluid;
a sensing portion having a memory component, said sensing portion being arranged for sensing conductivity of bio-processing fluid passing through said conduit, said sensing portion having a structure for measuring the temperature; and
said apparatus is made of inexpensive disposable material suitable for single use of the apparatus. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification