Method for preventing an unauthorized use of biprocess components

• US 9,946,902 B2
• Filed: 06/17/2016
• Issued: 04/17/2018
• 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): BEE, ANDREW W.
• Application Number:
  US15/185,977
• Publication Number:
  US 20160379019A1
• Time in Patent Office: 669 Days
• 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:

attaching a radio-frequency identification (RFID) device to a bioprocess component, the RFID device including ferro-electric random access memory (FRAM) configured to store data associated with the bioprocess component;

writing error-correctable information to the FRAM;

sterilizing the bioprocess component with the RFID device attached thereto using radiation, wherein at least one region of the FRAM is corrupted by the radiation;

reading the error-correctable information from the FRAM; and

authenticating the bioprocess component by processing the error-correctable information, including data from the at least one region corrupted by the radiation.

2. The method of claim 1, wherein the writing includes using an encoding algorithm.

3. The method of claim 1, wherein at least one of the reading and the authenticating includes using a decoding algorithm.

4. The method of claim 1, wherein the reading includes obtaining multiple readings of the FRAM at different distances between an RFID reader and the RFID device.

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

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

7. The method of claim 1, wherein the RFID device includes complementary metal-oxide-semiconductor (CMOS) circuitry and the method further includes initializing the RFID device by applying a RF signal to the CMOS circuitry.

8. The method of claim 7, wherein the authenticating further includes determining that data from the at least one region corrupted by the radiation is different than data from other regions of the multiple regions.

9. The method of claim 1, wherein the radiation is gamma radiation.

10. The method of claim 1, wherein the processing includes analyzing data from multiple regions of the FRAM.

11. The method of claim 1, wherein the authenticating includes at least one of:

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

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

(c) determining a pedigree of the bioprocess component;

(d) using a cryptographic or cryptological key;

or

(e) the matching a serial number of the bioprocess component.

12. An apparatus comprising:

a bioprocess component configured to be sterilized through radiation; and

an RFID device (i) coupled to the bioprocess component, and including;

a Ferro-electric random access memory (FRAM) configured to store data associated with the bioprocess component including error-correctable information to be written to the FRAM,

wherein the bioprocess component is configured to be sterilized with the RFID attached thereto using the radiation, wherein at least one region of the FRAM is corrupted by the radiation, and

wherein the error-correctable data of the RFID device is to be authenticated by processing the error-correctable data including data from the at least one region of the FRAM corrupted by the radiation and the RFID device is configured to wirelessly transmit authentication data from multiple regions of the FRAM, including data from the at least one region and data from at least one uncorrupted region of the FRAM.

13. The apparatus of claim 12, wherein the RFID device includes at least one of a physical, chemical, or biological sensor.

14. The apparatus of claim 13, wherein the RFID device includes an analog input that is operably coupled to the at least one physical, chemical, or biological sensor.

15. The apparatus of claim 12, wherein the FRAM includes CMOS circuitry capable of being initialized by an RF signal.

16. The apparatus of claim 12, 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.

17. The apparatus of claim 12, wherein the bioprocess component is a single-use disposable component.

18. The apparatus of claim 12, wherein the radiation is gamma radiation.

19. The apparatus of claim 18, wherein the radiation has a dose in the range of about 5 kGy to 35 kGy.

20. The apparatus of claim 19, wherein the radiation has a dose greater than about 8 kGy.