Bioprocess data management

• US 20090273447A1
• Filed: 01/22/2009
• Published: 11/05/2009
• Est. Priority Date: 05/08/2007
• Status: Active Grant

• Current Assignee: Finesse Solutions, Inc. (Thermo Fisher Scientific Incorporated)
• Original Assignee: Finesse Solutions LLC
• Inventors: Paldus, Barbara, Selker, Mark, Kamas, Charles
• Granted Patent: US 9,050,379 B2
• Time in Patent Office: Days
• US Class Current: 340/10.100
• 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 system for a biological process, comprising:

a. a single-use component or assembly,

b. a RFID tag including a non-volatile memory storage component that is exclusively associated with the single-use component or assembly,

c. the memory storage component including a unique identification, a memory, and at least one data element that describes a key performance, control, or calibration parameter of the single-use component relevant to said biological process,

d. A memory reader useable to obtain the unique lot identification from the memory storage component and communicate at least one data element to allow measurement of the said parameter.

2. The data management system of claim 1, wherein the single-use component is an assembly of a plurality of single-use components, each of said components having its own tag.

3. The data management system of claim 1 wherein the memory reader is a transmitter.

4. The data management system of claim 3 wherein the transmitter is used for the measurement of a bio-process relevant parameter

5. The system of claim 4 wherein said bio-process parameter is pH, dissolved oxygen, dissolved CO₂, temperature, pressure, level, foam, cell density, cell viability, metabolites such as glucose, lactate, glutamine, glutamate or ammonia, anti-form, additives, amino acids, or a bio-process end product comprising a protein, antibody or plasmid.

6. The data management system of claim 1 wherein the memory reader is a component of the process control system.

7. The data management system of claim 1 wherein the memory storage component is a non-volatile memory that is not adversely affected by gamma radiation.

8. The data management system of claim 7 wherein the memory storage component utilizes FRAM.

9. The data management system of claim 1 wherein the memory storage component is a RFID tag comprising a material not adversely affected by gamma radiation.

10. The RFID tag of claim 9 having a substantially planar configuration and a surface area no greater than about 150 cm²

11. The data management system of claim 9 wherein the memory storage device utilizes FRAM.

12. The data management system of claim 8 wherein the memory storage device is utilizes an EEPROM

13. The data management system of claim 1, wherein the data element is at least one calibration constant for a sensor.

14. The data management system of claim 1, wherein the data element is at least one critical additive for a bio-process media.

15. The data management system of claim 1, wherein additional information is stored in the memory, including at least one 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, calibration data, lifetime data, composition data, or customer application data associated with the identification number.

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

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

i) attaching a gamma radiation proof RFID tag comprising a non-volatile memory storage component to a single use component applicable to said biological process, ii) entering the appropriate data concerning the component on the tag, iii) gamma radiation sterilizing the single use component and tag, and iv) reading the data from the tag and inputting said data into the calibration system for said biological process.

18. A method in accordance with claim 17 wherein at least a portion of said data contains an encrypted URL.