Bioprocess data management
First Claim
Patent Images
1. A data management and calibration system for use with sensors and control systems for a biological process, the data management and calibration system comprising:
- i. a disposable single-use component comprising electrodes and a sensor, the disposable single-use component being configured to measure a process control parameter directly applicable to the biological process,ii. a non-volatile memory storage component which is permanently affixed to the single use component and which is programmed prior to gamma irradiation of the memory storage component and the single use component to which it is affixed, both the single use component and the memory storage component not being adversely affected by gamma radiation, the memory storage component including a unique identification code, a memory, and at least one already entered, prior to gamma irradiation, data element that provides a calibration parameter for calculating sensor output values from the single use component to thereby enable the single use component to measure the process control parameter in real time, wherein the non-volatile memory storage component is configured to be non-writable by a user after gamma irradiation, andiii. a memory reading system comprising at least a reader in physical contact with the memory storage component and which supplies the memory storage component with power and which also functions to;
a) obtain the unique identification code and the calibration parameter from the memory storage component, b) utilize the calibration parameter to enable the single-use component to measure the process control parameter, and c) transmit a measured process control parameter to a biological process control system, wherein the electrodes enable the non-volatile memory storage component to interface with the memory reading system.
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Abstract
A data management system for a biological process, comprising:
- a. a single-use component,
- b. a tag assembly, including a non-volatile memory storage component, that is associated with the single-use component,
- c. the memory storage component including a unique identification and a memory, and at least one data element that describes a key performance, calibration or control parameter of the single-use component
- d. a memory reader useable to obtain the identification from the memory storage component.
32 Citations
18 Claims
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1. A data management and calibration system for use with sensors and control systems for a biological process, the data management and calibration system comprising:
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i. a disposable single-use component comprising electrodes and a sensor, the disposable single-use component being configured to measure a process control parameter directly applicable to the biological process, ii. a non-volatile memory storage component which is permanently affixed to the single use component and which is programmed prior to gamma irradiation of the memory storage component and the single use component to which it is affixed, both the single use component and the memory storage component not being adversely affected by gamma radiation, the memory storage component including a unique identification code, a memory, and at least one already entered, prior to gamma irradiation, data element that provides a calibration parameter for calculating sensor output values from the single use component to thereby enable the single use component to measure the process control parameter in real time, wherein the non-volatile memory storage component is configured to be non-writable by a user after gamma irradiation, and iii. a memory reading system comprising at least a reader in physical contact with the memory storage component and which supplies the memory storage component with power and which also functions to;
a) obtain the unique identification code and the calibration parameter from the memory storage component, b) utilize the calibration parameter to enable the single-use component to measure the process control parameter, and c) transmit a measured process control parameter to a biological process control system, wherein the electrodes enable the non-volatile memory storage component to interface with the memory reading system. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of data management and calibration for controlling a biological process, comprising in sequence the steps of:
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i) permanently affixing a non-volatile memory storage component to a single use component configured to measure a process control parameter for the biological process, the non-volatile memory storage component having a unique identification code and both the non-volatile memory storage component and the single use component being gamma radiation resistant, ii) entering calibration data for calculating sensor output values from single use component to thereby enable the single use component to measure the process control parameter from the single use component on the non-volatile memory storage component, iii) after ii), gamma radiation sterilizing the single use component and the affixed non-volatile memory storage component, wherein the non-volatile memory storage component is configured to be non-writable by a user after gamma irradiation, iv) after iii) reading and validating the unique identification code present on the non-volatile memory storage component, and reading and using the calibration data entered on the non-volatile memory storage component to measure the process control parameter, wherein the unique identification code and the calibration data are transmitted from the non-volatile memory storage component through electrodes that interface with a memory reading system, v) transmitting a measured process control parameter to a control system for controlling the biological process, and vi) discarding the non-volatile memory storage component and the affixed disposable single use component after completion of the biological process. - View Dependent Claims (16, 17, 18)
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Specification