Bioprocess data management
First Claim
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1. A calibration system for use with sensors and control systems for a biological process, the calibration system comprising:
- (a) a single-use component comprising a sensor, the single-use component being configured to measure a process control parameter used to control the biological process;
(b) a non-volatile memory storage component 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, wherein the memory storage component is resistant to the gamma radiation; and
(c) the memory storage component storing 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 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 the gamma irradiation.
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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.
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Citations
31 Claims
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1. A calibration system for use with sensors and control systems for a biological process, the calibration system comprising:
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(a) a single-use component comprising a sensor, the single-use component being configured to measure a process control parameter used to control the biological process; (b) a non-volatile memory storage component 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, wherein the memory storage component is resistant to the gamma radiation; and (c) the memory storage component storing 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 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 the gamma irradiation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of calibration in a biological process, the method comprising:
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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, wherein the non-volatile memory storage component is resistant to the gamma radiation; (ii) entering a data element in the non-volatile memory storage component, wherein the data element comprises 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; (iii) after (ii), gamma radiation sterilizing the single use component and the affixed non-volatile memory storage component; (iv) after (iii), reading and using the calibration parameter entered on the non-volatile memory storage component to measure the process control parameter; and (v) transmitting a measured process control parameter to a control system for controlling the biological process, wherein the non-volatile memory storage component is configured to be non-writable by a user after the gamma irradiation. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification