GAMMA STERILIZABLE RFID SYSTEM THAT PREVENTS UNAUTHORIZED OPERATION OF ASSOCIATED DISPOSABLE BIOPROCESS COMPONENTS

• US 20110006878A1
• Filed: 08/20/2008
• Published: 01/13/2011
• 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, Singh, Vijay, Morris, William G., Potyrailo, Radislav A., Gach, Gerard J., Pizzi, Vincent F.
• Granted Patent: US 8,963,684 B2
• Time in Patent Office: Days
• 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 preventing an unauthorized use of a disposable component, the method comprising:

fabricating an RFID device and a disposable component;

integrating the RFID device with the disposable component;

writing error-correctable information onto a memory portion of a memory chip of the RFID device;

sterilizing the disposable component and the integrated RFID device;

assembling the disposable component in a biological fluid flow;

detecting and correcting possible errors in the error-correctable information caused by sterilization; and

determining if the disposable component is authenticated.

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

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

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

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

6. The method of claim 1, wherein the RFID device is an RFID tag and sensor.

7. The method of claim 1, wherein sterilizing the disposable component and the integrated RFID device further comprises providing gamma irradiation with a dose in the range from 5 to 100 kGy.

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

21. The method of claim 1, further comprising providing a reader/writer to write error-correctable information onto the FRAM portion of the memory chip.

9. A method of preventing an unauthorized use of a disposable component, the method comprising:

fabricating an RFID tag and a disposable component;

integrating the RFID tag with the disposable component;

writing error-correctable information to a ferroelectric random memory (FRAM) portion of a memory chip of the RFID tag;

reducing bio-burden of the disposable component with the integrated RFID tag;

assembling the disposable component in a biological fluid flow; and

determining if the disposable component is authenticated.

10. The method of claim 9, wherein reducing bio-burden of the disposable component and the integrated RFID tag is performed by sterilization.

11. The method of claim 9, further comprising providing user-critical data if the disposable component is authenticated.

12. The method of claim 9, wherein sterilizing the disposable component with the integrated RFID tag includes providing gamma radiation sterilization.

13. The method of claim 10, where in the user critical digital data is a lot or batch number.

14. The method of claim 10, wherein the user critical digital data is manufactured data.

15. The method of claim 9, wherein the disposable component is a disposable bioprocess component.

16. The method of claim 9, wherein the memory chip includes a complementary metal-oxide semiconductor (CMOS) circuitry.

17. The method of claim 9, wherein writing data to the plurality of regions of the FRAM further comprises dividing the memory chip into a plurality of sectors.

18. The method of claim 17, wherein the plurality of sectors include a first sector, a second sector and a third sector.

19. The method of claim 18, wherein the first sector includes article identification information or a serial number.

20. The method of claim 18, wherein the second sector includes authentication information.

22. A method of preventing an unauthorized use of a disposable component, the method comprising:

integrating an RFID tag with the disposable component;

writing redundant information on a Ferro-electric random access memory (FRAM) chip of the RFID tag;

sterilizing the disposable component with the integrated RFID tag;

assembling the disposable component in a biological fluid flow;

determining if the disposable component is authenticated; and

releasing digital data on the RFID tag if the disposable component is authenticated.

23. The method of claim 22, wherein the disposable bioprocess component with the integrated RFID tag is gamma sterilized.

24. The method of claim 22, wherein the disposable component is 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.

25. A method for preventing an unauthorized use of a disposable bioprocess component with the RFID tag where a memory of the memory chip of the RFID tag has a maximum available data capacity;

fabricating an RFID tag that includes the memory chip that contains both a CMOS circuitry and a FRAM circuitry;

fabricating a disposable bioprocess component;

integrating the RFID tag with the disposable bioprocess component;

initializing the memory chip by applying RF signal to the CMOS circuitry and writing redundant information to a plurality of regions in the FRAM circuitry of the memory chip of the RFID tag;

reducing bio-burden of the disposable bioprocess component with the integrated RFID tag;

assembling the disposable bioprocess component in a biological fluid flow;

authenticating the disposable bioprocess component with the RFID tag; and

releasing the available memory from the redundant information of the memory chip to the end-user.

26. A method for preventing an unauthorized use of a disposable bioprocess component, the method comprising:

fabricating an RFID tag with a memory chip that contains both a radiation-hardened CMOS circuitry and a FRAM circuitry;

fabricating a disposable bioprocess component;

integrating the RFID tag with the disposable bioprocess component;

initializing the memory chip by applying RF signal to the radiation-hardened CMOS circuitry and writing error-correctable information to a plurality of regions in the FRAM circuitry of the memory chip of the RFID tag;

sterilizing the disposable bioprocess component with the integrated RFID tag;

assembling the disposable bioprocess component in a biological fluid flow; and

authenticating the disposable bioprocess component with the RFID tag.

27. A method for preventing an unauthorized use of a disposable bioprocess component, the method comprising:

fabricating an RFID tag with a memory chip that contains both a CMOS circuitry and a FRAM circuitry,

fabricating a disposable bioprocess component;

integrating the RFID tag with the disposable bioprocess component;

initializing the memory chip by applying RF signal to the CMOS circuitry and writing error-correctable information to a plurality of regions in FRAM part of the memory chip of the RFID tag;

gamma-sterilizing the disposable bioprocess component with the integrated RFID tag;

assembling the disposable bioprocess component in a biological fluid flow;

recovering the CMOS circuitry after the gamma irradiation; and

authenticating the disposable bioprocess component with the RFID tag.