Method for preventing an unauthorized use of disposable bioprocess components

• US 8,653,940 B2
• Filed: 08/20/2008
• Issued: 02/18/2014
• 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:
  US12/921,598
• Publication Number:
  US 20110006900A1
• Time in Patent Office: 2,008 Days
• Field of Search: 340/572.1, 340/5.8, 340/10.1, 340/603, 340/606, 235/375, 235/376
• US Class Current: 340/5.8
• 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) sensor to a bioprocess component, the RFID sensor including ferro-electric random access memory (FRAM) chip, the RFID sensor configured to sense at least one of a physical, chemical, or biological characteristic in the bioprocess component;

writing error-correctable information to the FRAM chip, wherein the error-correctable information contains identifying information or calibration parameters of the RFID sensor;

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

reading the error-correctible information from the FRAM chip, including data from the at least one region corrupted by the radiation, after sterilizing the bioprocess component with the RFID sensor; and

analyzing or processing the information, including the data from the at least one region corrupted by the radiation, to authenticate the bioprocess component.

2. The method of claim 1, wherein writing error-correctable information includes writing the error-correctable information using an encoding algorithm and wherein at least one of reading or analyzing or processing the data includes using a decoding algorithm.

3. The method of claim 1, wherein reading the error-correctible information from the FRAM chip includes obtaining multiple readings of the FRAM chip at different distances between an RFID reader and the RFID sensor or obtaining multiple readings of the FRAM chip with the RFID reader at different power levels of the RFID reader.

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

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

6. A method comprising:

attaching a radio-frequency identification (RFID) sensor to a bioprocess component, the RFID sensor including ferro-electric random access memory (FRAM) chip, the RFID sensor configured to sense at least one of a physical, chemical, or biological characteristic in the bioprocess component;

writing copies of data to a plurality of different regions of the FRAM chip, wherein each of the copies of the data contains identifying information or calibration parameters of the RFID sensor;

sterilizing the bioprocess component with the RFID sensor using radiation, wherein at least one of the different regions of the FRAM chip is corrupted by the radiation;

reading the copies of the data from the different regions of the FRAM chip, including the data from the at least one different region that is corrupted by the radiation, after sterilizing the bioprocess component with the RFID sensor; and

analyzing or processing the data, including the data from the at least one different region that is corrupted by the radiation, to authenticate the bioprocess component.

7. The method of claim 6, wherein reading the copies of the data includes obtaining multiple readings of the FRAM chip with an RFID reader at different power levels of the RFID reader.

8. The method of claim 6, wherein reading the copies of the data includes obtaining multiple readings of the FRAM chip at different distances between an RFID reader and the RFID sensor.

9. The method of claim 6, wherein analyzing or processing the data includes identifying the regions that are corrupted by comparing the data from the different regions.

10. The method of claim 6, wherein analyzing or processing the data includes identifying the data that is located in a majority of the regions of the FRAM chip by comparing the data from the different regions.

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

12. The method of claim 6, wherein the FRAM chip has a total memory, the total memory being apportioned into at least first and second sectors, each of the first and second sectors having a plurality of regions, wherein writing the copies of the data to a plurality of the different regions includes writing copies of first data to the regions of the first sector and writing copies of second data, which is different than the first data, to the regions of the second sector.

13. The method of claim 6, wherein the different regions constitute separate blocks of memory, the method further comprising releasing at least some of the blocks of memory for use by an end user after the bioprocess component is authenticated thereby allowing the end user to write information into the at least some memory blocks.

14. The method of claim 6, wherein the RFID sensor includes complementary metal-oxide-semiconductor (CMOS) circuitry, the method further comprising initializing the RFID sensor by applying a RF signal to the CMOS circuitry.