METHOD FOR PREVENTING AN UNAUTHORIZED USE OF DISPOSABLE BIOPROCESS COMPONENTS

• US 20110006900A1
• 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 8,653,940 B2
• Time in Patent Office: Days
• US Class Current: 340/572.1
• 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 for preventing an unauthorized use of a disposable bioprocess component the method comprising:

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

fabricating a disposable bioprocess component;

adapting the RFID tag for physical, chemical, or biological sensing in disposable bioprocess component forming an RFID sensor;

integrating the resulting RFID sensor with the disposable bioprocess component;

initializing the memory chip by applying a RF signal to the CMOS circuitry;

writing error-correctable information to an FRAM portion of the memory chip wherein the error-correctable information contains calibration parameters of the RFID sensor;

sterilizing the disposable bioprocess component and the integrated RFID sensor;

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

authenticating the disposable bioprocess component and the RFID sensor.

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

fabricating an RFID tag that includes a memory chip that contains a CMOS circuitry, a FRAM circuitry, and analog input from a physical, chemical, or biological sensor;

attaching at least one sensor to the memory chip to form a RFID sensor;

fabricating a disposable bioprocess component;

integrating the RFID sensor with the disposable bioprocess component;

initializing the memory chip by applying a RF signal to the CMOS circuitry;

writing error-correctable information to a plurality of regions in the FRAM circuitry wherein the error-correctable information contains calibration parameters of the RFID sensor;

sterilizing the disposable bioprocess component and the integrated RFID sensor;

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

authenticating the disposable bioprocess component with the RFID sensor wherein authentication involves RFID sensor initialization and a change of its reading.

3. The method of claim 2, wherein the sensor is from the group consisting of physical sensor, chemical sensor, or biological sensor.

4. 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 a RF signal to the CMOS circuitry and writing redundant information to a plurality of regions in the FRAM circuitry;

gamma-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 when RFID tag reading is performed at different power levels of the RFID tag reader or at different distances between the reader and the RFID tag.