Split Valve Cam Assembly for Sterile Material Transfer
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Solution Overview
Problem
Conventional split butterfly valves face issues with maintaining sterility during material transfer due to exposure of critical surfaces when split, leading to potential contamination, and require excessive sterilizing medium and time, with fluctuating chamber volumes and mechanical strain on operators.
Innovation Solution
A split valve assembly with cam-based displacement means allows for precise and reproducible configuration changes between engaged and closed states, ensuring a consistent chamber volume for sterilization and minimizing exposure to non-sterile environments, using cams and cam followers to control valve portion displacement and maintain sterility throughout multiple dockings and undockings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If split valve is used for material transfer, then ease of operation is improved, but sterility is compromised due to exposure of critical surfaces
Solution Approach 1:
The valve portions are sterilized before engagement through autoclaving or steam sterilization. The design allows the valve to be sterilized in its engaged state, ensuring critical surfaces are sterilized before material transfer operations begin, thereby maintaining sterility while enabling easy operation.
Solution Approach 2:
A seal is introduced as an intermediary element between the first and second valve portions. This seal prevents exposure of critical surfaces to the non-sterile environment during operation, maintaining sterility while allowing the valve to function as a split valve for easy material transfer.
2Reliability
If conventional sterilization method is used, then sterility is achieved, but loss of time and loss of substance increase due to fluctuating chamber volumes
Solution Approach 1:
The locking ring with cam mechanism provides mechanical feedback to ensure the valve portions are precisely positioned in the sterilization configuration. This feedback mechanism eliminates uncertainty about chamber volume, allowing for optimized sterilization cycles that reduce both time and sterilizing medium consumption while ensuring complete sterility.
Solution Approach 2:
The cam mechanism changes the geometric parameters of the valve assembly by precisely controlling the relative position of valve portions. This parameter control creates a defined chamber volume for sterilization, allowing optimization of sterilization parameters (time, temperature, medium flow) to reduce overall sterilization requirements.
3Ease of operation
If split valve is used for material transfer, then ease of operation is improved, but loss of substance occurs due to exposure to non-sterile atmosphere
Solution Approach 1:
A seal acts as an intermediary barrier between the sterile interior and non-sterile exterior environments. This seal prevents product contamination while allowing the split valve to remain operational, thus protecting the product without sacrificing ease of operation.
Solution Approach 2:
The seal can be designed as a disposable component that is replaced periodically or after each sterilization cycle. This approach ensures product protection against contamination while being cost-effective and simple to maintain, preserving both product integrity and operational ease.
4Reliability
If barrier isolator is used for containment, then sterility and containment are improved, but device complexity and cost increase
Solution Approach 1:
The valve is segmented into two separable portions that can be sterilized independently and then engaged. This segmentation allows for simpler sterilization procedures compared to full barrier isolators, reducing overall system complexity while maintaining sterility through the engaged configuration with seal.
Solution Approach 2:
The valve assembly is designed to be self-sterilizing through its engaged configuration where the seal creates a closed system. This self-service capability eliminates the need for complex external sterilization systems or barrier isolators, reducing device complexity while ensuring sterility.
5Reliability
If containment enclosure is mounted around process equipment, then sterility is improved, but ease of operation deteriorates due to hindrance to equipment operation
Solution Approach 1:
The containment function is segmented into the seal and locking mechanism integrated with the valve itself, rather than requiring a separate enclosing structure. This integration maintains sterility while preserving full ease of operation, as the valve can be opened, closed, and sterilized without hindrance from external enclosures.
Solution Approach 2:
The containment function is merged with the valve structure itself through the seal and locking ring mechanisms. This merging eliminates the need for separate containment enclosures that would hinder operation, achieving both sterility and ease of operation through the integrated design.
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
The solution ensures accurate and reproducible sterilization with reduced sterilizing medium usage and contact time, maintaining sterility and reducing operational strain, while accommodating compact designs for efficient processing environments.
Implementation Method 1
the displacement means comprises a cam mechanism, said cam mechanism comprising a cam and a cam follower, said cam and cam follower co-operating to transform rotational movement into linear displacement
Data Source
AI summary
A valve having an active 10 and passive 12 valve portion that are complementarily shaped such that the passive 12 valve portion can be received by and mated with the active 12 valve portion. Each valve portion has a generally cylindrical valve body 14, 16 complementarily shaped with respect to one another such that the passive 12 valve portion may be received by the active 10 valve portion. Each valve portion has a valve closure member 18, 20 in the form of a circular planar disc rotatably mounted in the housing via means of one or more spindles, 22, 24 and 22′, 24′. The valve portions have a number of configurations whereby they can be partially engaged such that the valve portions may be separated to form a channel or chamber between valve closure members or fully engaged such that chamber or channel is closed such that the valve closure members are proximally disposed to one another and the valve may be opened or closed to permit the passage of material therethrough.