FRAM RFID Tag Data Integrity After Gamma Sterilization

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Solution Overview

Problem

Existing RFID technologies are unable to authenticate and prevent illegal manufacturing and unauthorized operation of gamma sterilizable disposable bioprocess components.

Innovation Solution

Integration of a CMOS circuitry and a ferroelectric random memory (FRAM) chip in RFID tags, which are initialized with error-correctable information and sterilized along with the disposable components, allowing for authentication and error correction post-gamma irradiation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If gamma sterilization is applied to disposable bioprocess components with RFID tags, then sterilization effectiveness is improved, but data integrity in the RFID tag memory is compromised

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidRFID tag data integrity
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent implements error correction codes (ECC) and data redundancy mechanisms in the RFID tag memory before sterilization. Multiple copies of critical authentication data are stored, and ECC algorithms are pre-configured to detect and correct bit flips that may occur during gamma irradiation, thereby cushioning against information loss while maintaining sterilization effectiveness

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The patent transforms the harmful effect of gamma irradiation-induced bit flips into a beneficial authentication mechanism. By designing the system to expect and correct specific error patterns characteristic of gamma sterilization, the harmful radiation effect becomes a verified signature of proper sterilization, converting the harm into a benefit for authentication

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

2Measurement precision

If RFID tags are integrated with disposable bioprocess components for tracking, then identification capability is improved, but authentication and prevention of unauthorized use is not achieved

Engineering Contradiction:
Improveidentification capabilityVSAvoidauthentication capability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent performs preliminary authentication by writing unique authentication codes and digital signatures to the RFID tag memory during manufacturing, before the component reaches the user. This preliminary action ensures that when the component is later used, the authentication data is already in place and can be verified without requiring additional manufacturing steps

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces an intermediary authentication layer between the RFID tag and the bioprocess component system. This intermediary consists of encrypted authentication data stored in the RFID tag that acts as a mediator, allowing verification of component legitimacy without exposing sensitive information or requiring direct trust between the tag and the component

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of manufacture

If standard memory chips are used in RFID tags, then manufacturing cost is reduced, but data retention after gamma irradiation is not maintained

Engineering Contradiction:
Improvemanufacturing costVSAvoiddata retention after irradiation
Core Design Contradiction:
Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The patent changes the memory parameters by implementing specific error correction code configurations and data redundancy levels that are optimized for gamma irradiation environments. By adjusting the code rate, redundancy factors, and error correction algorithms, the system achieves radiation tolerance while using standard memory chips, balancing manufacturing cost with data retention stability

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Ensures the authentication and prevents unauthorized use of disposable bioprocess components by maintaining data integrity and functionality even after gamma sterilization, reducing the risk of counterfeit components.

Implementation Method 1

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

Methodology Applied
Scientific EffectFerroelectric memory effect:

Implementation Method 2

initializing the memory chip by applying RF signal to the complementary metal-oxide semiconductor (CMOS) circuitry

Methodology Applied
Scientific EffectElectromagnetic induction: Electromagnetic Induction

Implementation Method 3

sterilizing the disposable component with the integrated RFID tag; detecting and correcting possible errors in written data caused by gamma irradiation

Methodology Applied
Scientific EffectGamma radiation: Radiation

Data Source

PatentEP2255342B1A method for preventing an unauthorized use of disposable bioprocess components
Publication Date: 2018.10.17 GLOBAL LIFE SCIENCES SOLUTIONS USA LLC
  • EP2255342B1 patent drawingFigure 1
  • EP2255342B1 patent drawingFigure 2
  • EP2255342B1 patent drawingFigure 3

AI summary

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.