FeRAM RFID Tag for Bioreactor Sterilization Data Integrity
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current single-use bioreactor systems in biopharmaceutical processes face challenges in documenting the integrity check, as information is not stored on the container itself, leading to laborious tracing via lot numbers, and existing solutions do not ensure seamless integration of data before and after sterilization.
Innovation Solution
A disposable bioreactor system equipped with an RFID tag featuring a rewritable FeRAM memory that survives radiation sterilization, allowing dynamic documentation of the system's history, including integrity checks, product data, and environmental conditions, with an optional rechargeable battery unit for extended data logging and wireless charging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If integrity test information is not stored on the container itself, then the container structure remains simple, but data tracing becomes laborious and time-consuming
Solution Approach 1:
The container system stores and manages its own integrity test data through an RFID tag integrated into its structure. The container essentially serves itself by maintaining its own quality assurance information, eliminating the need for external tracking systems and manual documentation.
Solution Approach 2:
The patent replaces manual documentation and physical tracing methods with an electronic RFID-based data storage and retrieval system. This substitution of mechanical/manual processes with electronic systems enables rapid data access while integrating seamlessly into the container structure.
2Reliability
If a memory device is integrated into the RFID tag for data storage, then data integrity is maintained through sterilization, but the device complexity increases
Solution Approach 1:
The patent combines the memory device with the RFID tag into a single integrated component. This merging eliminates the need for separate data storage devices and reduces overall system complexity while ensuring that data storage capability survives the sterilization process.
Solution Approach 2:
The patent utilizes FeRAM technology which has specific physical properties that allow it to withstand radiation sterilization. By selecting a memory technology with appropriate radiation resistance parameters, the system maintains data integrity without requiring additional protective measures that would increase complexity.
3Reliability
If FeRAM memory is used in the RFID tag, then data survives radiation sterilization, but manufacturing precision requirements increase
Solution Approach 1:
The patent employs a disposable bioreactor system where the RFID tag with FeRAM is intended for single use. This approach allows the use of specialized memory technology that can withstand sterilization, as the entire system is discarded after one use, eliminating the need for repeated sterilization cycles that would accumulate manufacturing stress.
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
This solution enhances process reliability by providing immediate and accurate data on component conditions, reducing manufacturer complaints and improving supply chain efficiency, while ensuring data integrity and compatibility checks are performed seamlessly.
Implementation Method 1
a rewritable memory, in particular a FeRAM memory, in which data relating to an integrity check of the disposable bioreactor system are stored
Implementation Method 2
The information is then read from the RFID tag and fed into a calibration system for the biological process
Data Source
Figure 1
Figure 2~3
AI summary
The invention relates to a radiation-sterilizable disposable bioreactor system, which is provided for use in a biopharmaceutical process, and which comprises an RFID tag and a basically rewritable memory, in which data relating to an integrity check of the disposable bioreactor system is stored. The invention further relates to a method for quality assurance of such a disposable bioreactor system, which method comprises the following steps: providing the disposable bioreactor system with an RFID tag and a basically rewritable memory, in particular of the FeRAM type, which is preferably a constituent part of the RFID tag; carrying out an integrity check of at least one component of the disposable bioreactor system before sterilization of the disposable bioreactor system by means of radiation; and writing data with respect to the integrity check into the memory before the sterilization of the disposable bioreactor system.