Gamma sterilizable RFID system that prevents unauthorized operation of associated disposable bioprocess components

• US 8,963,684 B2
• Filed: 08/20/2008
• Issued: 02/24/2015
• Est. Priority Date: 03/27/2008
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions USA LLC (Danaher Corporation)
• Original Assignee: GE Healthcare Bio-Sciences Corporation (General Electric Company)
• Inventors: Nyffeler, Manuel, Potyrailo, Radislav A., Pizzi, Vincent F., Morris, William G., Gach, Gerard J., Singh, Vijay
• Primary Examiner(s): BROWN, VERNAL U
• Application Number:
  US12/921,459
• Publication Number:
  US 20110006878A1
• Time in Patent Office: 2,379 Days
• Field of Search: 340/5.8, 340/572.1, 340/10.1, 340/603, 340/606, 235/375, 235/376
• US Class Current: 340/5.8
• CPC Class Codes: C12M 41/48 Automatic or computerized control automatic analysis G01N35/00
• 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: G06Q 20/3278 RFID or NFC payments by means of M-devices
• CPC Class Codes: G06Q 20/409 Device specific authentication in transaction processing
• CPC Class Codes: G11C 11/22 using ferroelectric elements

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 (FRAM) chip to store error-correctable information on a RFID tag attached to the disposable bioprocess components, where the error-correctable information is written into the memory chip, so that the 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 of authenticating a component to confirm the component is suitable for use, the method comprising:

receiving a component having a radio-frequency identification (RFID) device attached thereto, the RFID device including memory having redundant authentication information therein, wherein the component and the RFID device have been sterilized using radiation, at least one region of the memory being corrupted by the radiation;

obtaining multiple readings of the memory, including data from the at least one region corrupted by the radiation, the multiple readings being obtained by an RFID reader that at least one of (a) uses different power levels to read the memory or (b) is located at different distances from the RFD device when the memory is read;

analyzing the multiple readings to determine the authentication information; and

authenticating the component using the authentication information to confirm that the component is suitable for use, wherein authenticating includes analyzing or processing the authentication information in a predetermined manner.

2. The method of claim 1, wherein the memory includes a ferroelectric random memory (FRAM).

3. The method of claim 1, wherein the memory includes non-charge-based storage memory.

4. The method of claim 1, wherein the RFID device includes an RFID tag.

5. The method of claim 1, wherein the RFID device includes an RFID sensor.

6. The method of claim 1, wherein receiving the component having the RFID device attached thereto includes sterilizing the component and the attached RFID device using gamma irradiation with a dose in the range from 5 to 100 kGy.

7. The method of claim 1, wherein the error-correctable information is redundant information written to a plurality of regions of the memory.

8. The method of claim 1, wherein the memory includes multiples copies of the error-correctable information at different regions of the memory including the at least one region corrupted by the radiation.

9. The method of claim 8, wherein analyzing the multiple readings includes identifying the at least one region that is corrupted by the radiation by comparing data from the other regions.

10. The method of claim 8, wherein analyzing the multiple readings includes determining that data of the at least one region corrupted by the radiation is different than data of the other regions.

11. The method of claim 1, wherein the memory is part of a memory chip including a CMOS portion and a FRAM portion, wherein the at least one region corrupted by radiation is part of the FRAM portion.

12. The method of claim 1, wherein authenticating the component using the authentication information 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-race plausibility check;

(c) determining a pedigree of the component;

(d) using a crypographic or cryptological key;

or (d) matching a serial number of the component.

13. A method of authenticating a component to confirm the component is suitable for use, the method comprising:

receiving a component havin a radio-frequency identification (RFID) device attached thereto, the RFID device including memory having redundant authentication information therein, wherein the bioprocess component and the RFID device have been sterilized to reduce bio-burden, at least one region of the memory being corrupted by the sterilization;

obtaining multiple readings of the memory, including data from the at least one region corrupted by the sterilization, the multiple readings being obtained by an RFID reader that at least one of (a) uses different power levels to read the memory or (b) is located at different distances from the RFID device when the memory is read;

analyzing the multiple readings to determine the authentication information; and

authenticating the component using the authentication information to confirm that the component is suitable for use, wherein authenticating includes analyzing or processing the authentication information in a predetermined manner.

14. The method of claim 13, wherein the sterilization includes radiation exposure.

15. The method of claim 13, further comprising releasing user-critical data from the RFID device after authenticating the bioprocess component.

16. The method of claim 13, where in the user-critical data includes manufacturing information associated with the bioprocess component.

17. The method of claim 13, wherein the bioprocess component is a disposable bioprocess component.

18. The method of claim 13, wherein the memory portion includes complementary metal-oxide semiconductor (CMOS) circuitry.

19. The method of claim 13, wherein the memory includes ferroelectric random memory (FRAM).

20. The method of claim 19, wherein the FRAM includes a plurality of sectors.

21. The method of claim 20, wherein a first sector of the plurality of sectors includes article identification information or a serial number.

22. The method of claim 13, wherein the bioprocess component is selected from the group consisting of a stainless steel container, a bioreactor, a plastic container, a polymeric material container, a chromatography device, a filtration device and a centrifuge device,

23. The method of claim 13, wherein the memory includes multiples copies of the authentication information at different regions of the memory including the at least one region corrupted by the sterilization.

24. The method of claim 23, wherein analyzing the multiple readings includes identifying the at least one region that is corrupted by the sterilization by comparing data from the other regions.

25. The method of claim 23, wherein analyzing the multiple readings includes determining that the data of the at least one region corrupted by the sterilization is different than data of the other regions.

26. The method of claim 13, wherein the memory is part of a memory chip including a CMOS portion and a FRAM portion, wherein the at least one region corrupted by sterilization is part of the FRAM portion.