Closed System Transfer Device Assembly for Stopper Coring Control
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Solution Overview
Problem
The assembly of closed system transfer devices (CSTDs) to vials is arduous and can lead to stopper fragmentation or coring, contaminating the drug and clogging the spike, especially when manually secured.
Innovation Solution
A machine with a linear travel assembly and rotary assembly, controlled by a controller, that automates the alignment and attachment of CSTDs and vials, allowing for various speeds and rotational movements to simulate user techniques and reduce coring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual assembly of CSTD to vial is performed, then ease of operation is improved, but manufacturing precision deteriorates leading to stopper fragmentation and coring
Solution Approach 1:
The patent replaces manual mechanical assembly with an automated machine system that uses controlled mechanical forces. The machine applies precise axial force and rotational movement to attach the CSTD to the vial, eliminating human variability and preventing stopper fragmentation and coring while maintaining ease of operation through automation.
2Manufacturing precision
If automated assembly machine is used, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
The automated assembly machine is divided into distinct functional modules: a linear travel assembly for axial movement, a rotary assembly for rotational movement, and a controller for coordination. This segmentation allows each module to perform a specific function with high precision while keeping the overall system manageable and maintainable.
Solution Approach 2:
The machine is designed with universal fixtures and mounting mechanisms that can accommodate different sizes and types of vials and CSTD devices. The linear and rotary assemblies can be programmed to work with various configurations, reducing the need for multiple specialized machines and simplifying the overall system complexity.
3Device complexity
If manual assembly is performed, then device complexity is reduced, but reliability deteriorates due to human variability and coring
Solution Approach 1:
The controller monitors and coordinates the linear and rotary assemblies, providing feedback control to ensure precise alignment and force application during assembly. This feedback mechanism ensures consistent, repeatable results and prevents errors that would compromise reliability, while the automated system maintains manageable complexity through software control.
Solution Approach 2:
The machine allows for programmable control of assembly parameters such as axial force magnitude, rotational speed, and movement distance. By optimizing these parameters, the system achieves high reliability in preventing stopper fragmentation and coring while keeping the mechanical structure relatively simple through software-based parameter control rather than complex mechanical mechanisms.
Data Source
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AI summary
A closed system transfer device (CSTD) and vial assembly machine includes a linear travel assembly including a linear mount, and an actuator operably coupled to the linear mount. The linear mount is movable in an axial direction between a first position and a second position spaced from the first position. A CSTD fixture is configured to be removably coupleable to the linear mount. A vial mount is disposed adjacent to a portion of the linear travel assembly. A vial fixture is configured to be removably coupleable to the vial mount. The vial fixture is sized to hold a vial in axial alignment with a portion of the CSTD fixture when the vial fixture is coupled to the vial mount and the CSTD fixture is coupled to the linear mount. When the linear mount moves from the first position to the second position, the linear mount moves relative to the vial mount.