Method for preventing an unauthorized use of disposable bioprocess components

• US 9,373,008 B2
• Filed: 11/25/2013
• Issued: 06/21/2016
• Est. Priority Date: 03/27/2008
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions USA LLC (Danaher Corporation)
• Original Assignee: GE Healthcare Biosciences Bioprocess Corporation (General Electric Company)
• Inventors: Nyffeler, Manuel, Potyrailo, Radislav A., Pizzi, Vincent F., Morris, William G., Gach, Gerard J., Singh, Vijay
• Primary Examiner(s): Bee, Andrew
• Application Number:
  US14/088,749
• Publication Number:
  US 20140076973A1
• Time in Patent Office: 939 Days
• US Class Current: 1/1
• CPC Class Codes: G06K 19/0723 the record carrier comprising an arrangement for non-contact communication, e.g. wireless communication circuits on transponder cards, non-contact smart cards or RFIDs
• CPC Class Codes: G06K 19/14 the marking being sensed by radiation
• CPC Class Codes: G06K 7/0008 General problems related to the reading of electronic memory record carriers, independent of its reading method, e.g. power transfer
• CPC Class Codes: G06K 7/10009 sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves
• CPC Class Codes: G06Q 10/08 Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
• CPC Class Codes: G11C 11/22 using ferroelectric elements
• CPC Class Codes: G11C 11/221 using ferroelectric capacitors

Abstract

This invention provides a system and apparatus that is able to authenticate and prevent illegal manufacturing and unauthorized operation of disposable bioprocess components. This invention utilizes a ferro-electric random access memory chip (FRAM) chip to store error-correctable information on a RFID tag attached to the disposable bioprocess components, where the error-correctable information is written in sequence into the memory chip, so that the redundant information can remain in the chip when the RFID tag and disposable bioprocess component is gamma-sterilized. Also, this invention includes a method for authenticating the disposable bioprocess component that reduces liability in that a counterfeit poor quality disposable component is not used on the hardware so the user will not file an unjustified complaint.

Claims

1. A method comprising:

receiving a component including a radio-frequency identification (RFID) tag, the component with the RFID tag being sterilized through gamma radiation, the RFID tag including ferro-electric random access memory (FRAM) circuitry having a copy of data written in multiple regions of the FRAM circuitry, wherein at least one of the regions is corrupted by the gamma radiation;

reading the multiple regions, including the at least one region that is corrupted by the gamma radiation; and

analyzing the data from the multiple regions, including the data from the at least one region that is corrupted by the gamma radiation, to authenticate the component.

2. The method of claim 1, wherein analyzing the data from the multiple regions includes determining that the data of the at least one region corrupted by the gamma radiation is different than the data of the other regions.

3. The method of claim 1, wherein analyzing the data includes identifying the data that is located in a majority of the regions of the FRAM circuitry by comparing the data from the different regions.

4. The method of claim 1, wherein reading the multiple regions includes obtaining multiple readings of the FRAM circuitry with an RFID reader at different power levels of the RFID reader.

5. The method of claim 1, wherein reading the multiple regions of the data includes obtaining multiple readings of the FRAM circuitry at different distances between the RFID reader and the RFID tag.

6. The method of claim 1, wherein the component is a disposable bioprocess component.

7. The method of claim 1, wherein the different regions are separate blocks of memory, the method further comprising releasing at least some of the blocks of memory for use by an end user.

8. The method of claim 1, wherein receiving the component including the RFID tag includes sterilizing the component and the RFID tag using the gamma radiation with a dose in the range from 5 to 100 kGy.

9. The method of claim 1, wherein the component is a bioprocess component that is at least one of a container, a cell culture bioreactor, a mixing bag, a sterilization container, a metal container, a plastic container, a polymeric material container, a chromatography device, a filtration device, a chromatography device, a filtration device, a centrifuge device, a connector, a fitting, a centrifuge device, a bag, a tube, a pipe, or a hose.

10. The method of claim 1, wherein analyzing the data to authenticate the component includes at least one of:

(a) using identification information that identifies the component or is uniquely associated with the component;

(b) using a track-and-trace plausibility check;

(c) determining a pedigree of the component;

(d) using a cryptographic or cryptological key;

or

(e) matching a serial number of the component.

11. A radio-frequency identification (RFID) system comprising:

a reader configured to be positioned within a read range of a component including a RFID tag, the RFID tag having ferro-electric random access memory (FRAM) circuitry with a copy of data written in multiple regions of the FRAM circuitry, wherein the component has been sterilized through gamma radiation such that at least one of the regions has been corrupted by the gamma radiation;

wherein the reader is configured to read the multiple regions of the FRAM circuitry, including the at least one region that is corrupted by the gamma radiation, and analyze the data from the multiple regions, including the data from the at least one region that is corrupted by the gamma radiation, to authenticate the component.

12. The RFID system of claim 11, wherein the reader is configured to identify one or more regions of the FRAM circuitry that are corrupted by comparing the copies of the data.

13. The RFID system of claim 11, wherein the reader is configured to identify the data that is located in a majority of the regions of the FRAM circuitry by comparing the data from the different regions.

14. The RFID system of claim 11, wherein the reader is configured to obtain multiple readings of the FRAM circuitry at different power levels of the reader.

15. The RFID system of claim 11, wherein the reader is configured to obtain multiple readings of the FRAM circuitry at different reading distances with respect to the RFID tag.

16. The RFID system of claim 11, wherein the reader is configured analyze the data to authenticate the component by at least one of:

(a) using identification information that identifies the component or is uniquely associated with the component;

(b) using a track-and-trace plausibility check;

(c) determining a pedigree of the component;

(d) matching a serial number of the component.

17. The RFID system of claim 11, further comprising the component having the RFID tag.

18. An apparatus comprising:

a bioprocess component configured to be sterilized through gamma radiation to remove a bioburden; and

an RFID tag coupled to the bioprocess component and including ferro-electric random access memory (FRAM) circuitry and complementary metal-oxide semiconductor (CMOS) circuitry, the FRAM circuitry having a copy of data written in multiple regions of the FRAM circuitry, wherein at least one of the regions of the FRAM circuitry is corruptible by the gamma radiation and at least a portion of the CMOS circuitry is corruptible by the gamma radiation, the RFID tag having an antenna configured to wirelessly transmit the data from the multiple regions of the FRAM circuitry, including the at least one region that is corruptible by the gamma radiation.

19. The apparatus of claim 18, wherein the RFID tag includes at least one of a physical, chemical, or biological sensor.

20. The apparatus of claim 19, wherein the RFID tag includes an analog input that is operably coupled to the at least one physical, chemical, or biological sensor.

21. The apparatus of claim 18, wherein the CMOS circuitry is capable of being initialized by an RF signal.

22. The apparatus of claim 18, wherein the bioprocess component is at least one of a container, a cell culture bioreactor, a mixing bag, a sterilization container, a metal container, a plastic container, a polymeric material container, a chromatography device, a filtration device, a chromatography device, a filtration device, centrifuge device, a connector, a fitting, a centrifuge device, a bag, a tube, a pipe, or a hose.