Multi-Ingredient Compounder Valve Caps for Cross-Connection Prevention
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Solution Overview
Problem
Multi-ingredient compounders face issues with cross-connection errors during setup, leading to inaccuracies in ingredient amounts, sequence, and flow parameters, which can result in errors in therapeutic formulations.
Innovation Solution
A disposable apparatus with a manifold and valve system that includes caps which can be locked and unlocked to prevent incorrect connections, along with a controller to manage the interconnection sequence, ensuring accurate setup and reducing cross-connection errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual interconnection of tubing sets to inlet ports is performed without restrictions, then setup speed is improved, but cross-connection errors increase
Solution Approach 1:
Caps are introduced as intermediary elements between the tubing sets and inlet ports. These caps physically block incorrect connections while allowing correct ones, serving as a mediator that guides proper setup without slowing down the process. The caps are selectively removable to permit interconnection of specific inlet ports to specific tubing sets in a predetermined sequence.
Solution Approach 2:
The caps are pre-installed on inlet ports before the tubing sets are connected. This preliminary action establishes a controlled setup sequence where only designated inlet ports are accessible at each stage, preventing cross-connection errors before they can occur while maintaining efficient setup speed.
2Reliability
If caps are provided on all inlet ports to prevent cross-connection errors, then connection accuracy is improved, but device complexity increases
Solution Approach 1:
Rather than uniformly complexifying the entire apparatus, the solution applies caps selectively to specific inlet ports where cross-connection errors are most likely to occur. This localized approach provides necessary protection against errors while minimizing the addition of components and overall system complexity.
3Manufacturing precision
If automated control of valve members is implemented, then compounding precision is improved, but ease of operation during setup deteriorates
Solution Approach 1:
The setup process is segmented into distinct phases: manual cap removal and tubing connection phase, followed by automated valve control phase. This segmentation allows operators to perform simple manual tasks initially, then transitions to automated precision control, combining ease of operation with compounding precision without requiring operators to manage complex automated systems throughout the entire setup process.
Data Source
AI summary
Apparatus and systems are disclosed for improved set-up of multi-ingredient compounders. An improved apparatus includes a manifold and a plurality of valve members disposed for movement relative to different corresponding ones of a plurality of inlet ports of the manifold. The valve members are moveable to open and close a corresponding fluid passageway between the corresponding inlet port and an internal passageway of the manifold. A plurality of caps are locatable on different corresponding ones of the inlet ports, with each of the caps being engageable with the corresponding valve member for co-movement from a locked position at which the cap is restricted from removal to an unlocked position at which the cap is removable, e.g. by manual, axial retraction of the cap. An improved system includes a compounder controller operable to control valve actuators of the compounder so as to sequentially move the valve members and corresponding caps from locked to unlocked positions in a predetermined sequence, thereby reducing the potential for undesired cross-connections.