Bioprocess data management

• US 9,782,506 B2
• Filed: 05/06/2015
• Issued: 10/10/2017
• 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 D., Kamas, Charles, Paldus, Barbara
• Primary Examiner(s): Nguyen, An T
• Application Number:
  US14/705,797
• Publication Number:
  US 20150306267A1
• Time in Patent Office: 888 Days
• 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 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.

2. The calibration system of claim 1, wherein the single-use component is an assembly of a plurality of single-use components and at least one tag.

3. The calibration system of claim 1, further comprising a memory card reader, wherein the memory reader is a transmitter.

4. The 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, or a bio-process end product selected from the group consisting of a protein, an antibody, a plasmid, and a metabolite selected from the group consisting of glucose, lactate, glutamine, glutamate and ammonia.

5. The calibration system of claim 1, wherein the non-volatile memory storage component utilizes a ferro-electric RAM.

6. The calibration system of claim 1, wherein the memory storage component comprises a RFID tag comprising a material resistant to gamma radiation.

7. The calibration system of claim 6, wherein the RFID tag has a substantially planar configuration and a surface area no greater than about 150 cm².

8. The calibration system of claim 6, wherein the memory storage component utilizes FRAM.

9. The calibration system of claim 1, wherein the memory storage component utilizes an EEPROM.

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

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

12. The 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.

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

14. The calibration system of claim 13, wherein the single-use bioreactor assembly comprises a single-use bioreactor bag.

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

16. The calibration system of claim 15, wherein the single-use component comprises four electrodes.

17. The calibration system of claim 1, wherein the memory storage component stores additional information selected from the group consisting of a manufacturing date, a batch number, a lot number, material specifications, material lot number, certifications for sterility, certificates of compliance, size specification, functional specifications, description of device, expiration date, process data, lifetime data, composition data, and a unique identification code.

18. The calibration system of claim 17, wherein the additional information can be used by the biological process control system to ensure that the single use component is used only once.

19. The calibration system of claim 17, wherein both the calibration parameter and the additional information are programmed to the memory storage component prior to the gamma irradiation of the memory storage component and the single use component.

20. The calibration system of claim 1, wherein no further information is programmed to the memory storage component after the gamma irradiation of the memory storage component and the single use component.

21. A method of calibration in a biological process, the method comprising:

(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.

22. The method of claim 21, further comprising, after (iii), reading and validating the at least one data element present on the non-volatile memory storage component.

23. The method of claim 21, wherein the single-use component and the non-volatile memory storage component are configured to be physically connected to a memory reading system when utilizing the calibration parameter.

24. The method of claim 21, wherein during (iii), the at least one data element and the calibration parameter are transmitted from the non-volatile memory storage component through electrodes that interface with a memory reading system.

25. The method of claim 21, further comprising:

(vi) discarding the non-volatile memory storage component and the affixed single use component after completion of the biological process.

26. The method of claim 21, further comprising entering an encrypted URL on the non-volatile memory storage component prior to (iii).

27. The method of claim 21, further comprising integrating the single use component and the affixed non-volatile memory storage component into a single-use bioreactor assembly prior to gamma radiation sterilization of the single-use bioreactor assembly.

28. The method of claim 21, wherein entry of the data element on the non-volatile memory storage component is effected when the non-volatile memory storage component is fabricated.

29. The method of claim 21, wherein the process control parameter is pH, dissolved oxygen, dissolved CO₂, temperature, pressure, level, foam, cell density, cell viability, an anti-foamadditive, an amino acid, or a bio-process end product selected from the group consisting of a protein, an antibody, a plasmid, and a metabolite selected from the group consisting of glucose, lactate, glutamine, glutamate and ammonia.

30. The method of claim 21, further comprising storing additional information in the memory storage component, wherein the additional information is selected from the group consisting of a manufacturing date, a batch number, a lot number, material specifications, material lot number, a certification for sterility, a certificate of compliance, a size specification, a functional specification, a description of a device, an expiration date, process data, lifetime data, composition data, a unique identification code, and combinations thereof.

31. The method of claim 30, wherein both the calibration parameter and the additional information are programmed to the memory storage component prior to the gamma irradiation of the memory storage component and the single use component.