Bioprocess data management

• US 9,050,379 B2
• Filed: 01/22/2009
• Issued: 06/09/2015
• Est. Priority Date: 05/08/2007
• Status: Active Grant

• Current Assignee: Finesse Solutions, Inc. (Thermo Fisher Scientific Incorporated)
• Original Assignee: Finesse Solutions, Inc. (Thermo Fisher Scientific Incorporated)
• Inventors: Selker, Mark, Kamas, Charles, Paldus, Barbara
• Primary Examiner(s): Negron, Daniell L
• Assistant Examiner(s): BAMERT, JOHN J
• Application Number:
  US12/321,657
• Publication Number:
  US 20090273447A1
• Time in Patent Office: 2,329 Days
• US Class Current: 1/1
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: G06K 7/10366 the interrogation device being adapted for miscellaneous applications

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.

Claims

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, 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.

2. The data management and calibration system of claim 1 wherein the process control parameter is pH, dissolved oxygen, dissolved CO₂, temperature, pressure, level, foam, cell density, cell viability, an anti-foam additive, an amino acid, a bio-process end product comprising a protein, antibody or plasmid, or a metabolite selected from the group consisting of glucose, lactate, glutamine, glutamate and ammonia.

3. The data management and calibration system of claim 1 wherein the memory reading system is a component of the biological process control system.

4. The data management and calibration system of claim 3 wherein the biological process control system is utilized in conjunction with a disposable bioreactor.

5. The data management and calibration system of claim 1, wherein the data element comprises at least one calibration constant for the sensor.

6. The data management and calibration system of claim 1, wherein the data element describes at least one critical additive present in a biological process media.

7. The data management and calibration system of claim 1, wherein additional information is stored in the memory storage component, and the additional information includes information selected from the group consisting of a manufacturing date, a batch number, a lot number, a material specification, a material lot number, a certification for sterility, a certificate of compliance, a size specification, a functional specification, a description of the single use component, an expiration date, process data, calibration data, lifetime data, composition data, and customer application data associated with the unique identification code.

8. The data management and calibration system of claim 7 wherein the additional information is used by the biological process control system to ensure that the disposable single use component is used only once.

9. The data management and calibration system of claim 1 wherein the non-volatile memory storage component has a surface area no larger than 1 cm² and is no thicker than 1 mm.

10. The data management and calibration system of claim 1 wherein the single use component and the affixed non-volatile memory storage component are integrated into a disposable single-use bioreactor assembly prior to gamma irradiation sterilization of the disposable single-use bioreactor assembly.

11. The data management and calibration system of claim 10 wherein the disposable single-use bioreactor assembly comprises a bioreactor bag.

12. The data management and calibration system of claim 1, wherein the disposable single-use component and the non-volatile memory storage component are configured to be physically connected to the memory reading system when utilizing the calibration parameter.

13. The data management and calibration system of claim 12, wherein the disposable single-use component comprises four electrodes.

14. The data management and calibration system of claim 1, wherein the non-volatile memory storage component is a ferro-electric RAM.

15. A method of data management and calibration for controlling a biological process, comprising in sequence the steps of:

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.

16. A method in accordance with claim 15 further comprising entering an encrypted URL on the non-volatile memory storage component prior to iii).

17. A method in accordance with claim 15 wherein the single use component and the affixed non-volatile memory storage component are integrated into a single-use bioreactor assembly prior to gamma radiation sterilization of the single-use bioreactor assembly.

18. A method in accordance with claim 15 wherein entry of all desired performance, control and/or calibration data applicable to the single use component on the non-volatile memory storage component is effected when the non-volatile memory storage component is fabricated.