Optical Workflow Verification for Single-Use Biopharma Setup
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Solution Overview
Problem
The biopharmaceutical industry faces challenges with the adoption of single-use technology (SUT) due to frequent installation of complete fluid paths, large numbers of materials to handle, sourcing variability, and lack of standardization in consumables, leading to increased operational steps and costs in biopharmaceutical manufacturing.
Innovation Solution
A monitoring system that captures images of the manufacturing process and tracks operator interactions to verify compliance with predefined workflow process schemes, ensuring correct setup and operation of SUT equipment, thereby reducing errors and improving efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If single-use technology (SUT) is adopted to eliminate cross-contamination and improve flexibility, then product quality and manufacturing flexibility are improved, but the number of operational steps and material handling requirements increase
Solution Approach 1:
The system automatically performs verification of consumable installation and process setup without requiring manual verification steps. The image capture device and processing element enable the system to self-verify compliance with predefined workflows, eliminating the need for extensive manual operational steps while maintaining the flexibility benefits of SUT
Solution Approach 2:
Manual verification and documentation processes are replaced with an automated optical verification system. The image capture device captures visual information, and the processing element automatically compares it against predefined workflow schemes, substituting mechanical/manual verification steps with automated digital verification
2Loss of time
If single-use technology (SUT) is adopted to eliminate cleaning and sterilization steps, then time and cost are reduced, but the number of consumables to be installed and managed increases
Solution Approach 1:
The system provides automated feedback verification to confirm correct installation of consumables. The processing element compares captured images against predefined workflow schemes and provides verification feedback, ensuring that the increased number of consumables are properly installed without requiring additional manual verification time
Solution Approach 2:
The verification system operates autonomously to manage the increased complexity of consumable handling. The system self-verifies installation compliance without requiring additional operational steps, effectively managing the larger quantity of consumables through automated verification rather than manual processes
3Adaptability or versatility
If frequent installation and reconfiguration of SUT equipment is performed to accommodate different products, then product variety and customization are improved, but the risk of installation errors increases
Solution Approach 1:
The system provides automated verification feedback after each installation and reconfiguration event. The processing element compares the actual setup against predefined workflow schemes specific to each product, providing immediate feedback on compliance and reducing the risk of installation errors when accommodating different products
Solution Approach 2:
The system uses predefined workflow process schemes that are established in advance for different products. These preliminary defined protocols guide the installation and reconfiguration process, ensuring that each setup follows the correct procedure before actual manufacturing begins, thereby reducing installation errors
4Reliability
If manual verification and documentation processes are used to ensure compliance, then quality control is improved, but labor costs and processing time increase
Solution Approach 1:
Manual verification and documentation processes are replaced with an automated optical verification system. The image capture device and processing element automatically perform quality control verification and documentation, maintaining reliable quality control while eliminating the labor and time requirements of manual processes, thereby improving manufacturing throughput
Data Source
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AI summary
A monitoring system comprises a manufacture system with capability to manufacture a plurality of biopharmaceutical products, at least one image capture device arranged to capture a scene comprising the manufacture system, and a processing element connected to said at least one image capture device and arranged to process images captured by said at least one image capture device to track operator interactions and/or a result of operator interactions within the scene. The processing element is further is arranged to compare a predefined workflow process scheme relating to the selected biopharmaceutical product to at least a part of the tracked operator interactions with the manufacture system and/or to at least a part of the result of the tracked operator interactions with the manufacture system, and determine whether at least one pre-set criterion set by the workflow process scheme is fulfilled based on the comparison