Smart Container Local Output Guides Bioprocess User Actions
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Solution Overview
Problem
In bioprocesses, especially in cell and gene therapy, manual user interactions are error-prone and time-critical, posing risks to product safety and compliance, particularly in highly regulated environments where complex processes require precise handling and documentation of biological materials across multiple devices and locations.
Innovation Solution
The smart container integrates a local output arrangement controlled by a processor to guide users through actions, using screens, LEDs, and mechanical signifiers to ensure correct handling and reduce errors, while also processing data locally for integrity and documentation, and communicating with central systems for workflow management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual user interactions are used for bioprocess handling, then operational flexibility and decision-making capability are maintained, but error rates increase and product safety is compromised
Solution Approach 1:
The smart container autonomously performs identification, workflow retrieval, and user guidance functions without requiring manual operator intervention. The container self-identifies via RFID, automatically retrieves the appropriate workflow from the database, and provides real-time guidance through its interface, thereby eliminating manual errors while maintaining operational flexibility.
Solution Approach 2:
The system implements continuous feedback loops where the smart container communicates with the central database and receives real-time guidance instructions. The container's interface provides feedback to the user about current workflow steps, required actions, and system status, enabling error prevention through guided operation rather than relying on manual expertise alone.
2Reliability
If complex automated processes are implemented, then error rates decrease and compliance improves, but system complexity and initial setup requirements increase
Solution Approach 1:
The smart container serves multiple functions within a single device: it stores biological material, contains embedded RFID identification, provides a user interface for interaction, and communicates with the central database. This multi-functionality reduces the need for separate complex systems while maintaining automated compliance and process control.
Solution Approach 2:
The system performs preliminary actions by pre-configuring workflows in the central database and pre-identifying containers via RFID before processes begin. The container is pre-prepared with its unique identifier and associated workflow parameters, eliminating the need for complex setup during operation and reducing system configuration complexity.
3Reliability
If real-time user guidance is provided through local output, then user errors are reduced and compliance is ensured, but device complexity and power requirements increase
Solution Approach 1:
The smart container's local interface displays copied information from the central database workflow instructions rather than containing all processing logic locally. The container receives and displays guidance data that is generated centrally, reducing the computational complexity required in the container while still providing real-time user guidance for accurate actions.
4Reliability
If extensive documentation and training measures are implemented, then product quality and safety are ensured, but time consumption and operational efficiency decrease
Solution Approach 1:
The smart container provides self-service training and guidance through its local interface, which displays context-specific instructions and workflow steps tailored to the current operation. This eliminates the need for extensive external training programs and documentation review, as users receive relevant guidance in real-time during operation, maintaining product quality while reducing time consumption.
Data Source
Figure 1a~1b
Figure 2
Figure 3a~3b
AI summary
The invention relates to a smart container for performing a bioprocess and containing biological material, in particular liquid immune cell cultures, wherein the smart container (2) comprises a base (3), wherein the smart container (2) comprises on the base (3) a storage structure (5), in particular fluidic storage structure (5), for the biological material, wherein the smart container (2) comprises on the base (3) a control unit (7) with a processor (8) and a memory (9), wherein a workflow being part of the bioprocess is stored in the memory (9), wherein an identifier of the biological material is stored in the memory (9), wherein the workflow comprises a step with a user action performed by a user. It is proposed that the smart container (2) comprises a local output arrangement (11) controlled by the control unit (7), that the processor (8) of the control unit (7) generates a user output to guide the user in performing the user action and that the control unit (7) outputs the user output via the local output arrangement (11).