Sterile Fluid Transfer Device with Rotating Plunger Mechanism
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Solution Overview
Problem
Current fluid transfer systems in pharmaceutical and biopharmaceutical industries face challenges with contamination risks due to steam sterilization methods, high temperature and pressure differentials, and the need for rigorous cleaning and validation of reusable components, which increases costs and time-to-market.
Innovation Solution
A disposable, sterile fluid transfer device with a rotating body and linearly movable plunger that provides a steam sterilizable mating point and a sterilizable connection between upstream and downstream components, allowing for easy integration into traditional stainless steel systems and eliminating the need for cleaning and validation processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If steam sterilization is used to sterilize processing systems, then sterilization effectiveness is improved, but contamination risk increases when connections are made after steaming
Solution Approach 1:
The system is divided into sterile and non-sterile zones separated by a sterile barrier. The sterile barrier remains intact during steam sterilization, allowing the sterile side to be sterilized while the non-sterile side remains isolated. This segmentation prevents contamination when connections are made after sterilization.
Solution Approach 2:
A sterile barrier acts as an intermediary element between the steam sterilization process and the sterile process stream. This barrier allows thermal energy to pass through for sterilization while preventing direct contact between potential contaminants and the sterile interior, thus eliminating contamination risk during post-sterilization connections.
2Duration of action of stationary object
If reusable components are used in processing systems, then system durability is improved, but cleaning and validation time increases
Solution Approach 1:
The invention employs a disposable sterile barrier that is discarded after a single use, eliminating the need for cleaning and validation of components that contact the sterile process stream. This disposable approach maintains system durability through the barrier itself while removing time-consuming cleaning and validation steps entirely.
3Reliability
If high temperature steam is used for sterilization, then sterilization effectiveness is improved, but component selection becomes limited
Solution Approach 1:
The sterile barrier has different properties in different regions: it is thermally permeable to allow steam penetration for sterilization, yet selectively impermeable to prevent passage of contaminants. This local differentiation of properties enables the barrier to withstand high temperature steam while protecting the sterile side, expanding component selection beyond what would be possible with uniform material properties.
4Ease of manufacture
If disposable components are used instead of reusable components, then cleaning costs are reduced, but ease of operation may worsen
Solution Approach 1:
The sterile barrier is integrated with the process components to form a single disposable assembly. This merging eliminates the need for separate cleaning operations and simplifies operation by allowing the entire assembly to be replaced as one unit, thereby reducing cleaning costs while maintaining ease of operation through simplified replacement procedures.
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 device ensures a sterile fluid pathway while reducing contamination risks, simplifying the integration of disposable components, and minimizing costs and time-to-market by eliminating the need for extensive cleaning and validation processes.
Implementation Method 1
the body is formed from a rotating first section and a stationary second section, such that the first section rotates around a portion of the stationary second section and the plunger. The rotation of the first section engages the stationary second section and the plunger, driving the plunger linearly within the bore
Implementation Method 2
When the device is in the closed position, the first end of the plunger is in alignment with the connecting component at one end of the body, forming a seal against fluid in the upstream component from entering the device, thereby forming a steamable face and a sterile barrier
Data Source
Figure 1a~1b
Figure 2
Figure 3a~3b
AI summary
A disposable device for the sterile transfer of fluids, such as liquids or gases, includes a body, a bore formed through at least a portion of the interior of the body, and a linearly moveable plunger contained within the bore. The body is formed from a rotating section and a stationary section. Partial rotation of the rotating section around a portion of the stationary section and the plunger drives the plunger linearly within the bore, opening and closing the device. The plunger includes at least a first and a second opening, and a fluid channel in the interior of the plunger connecting the first and second openings forming a fluid pathway to downstream components when the device is open. A termination component at one end of the plunger connects to a downstream component. A flange at one end of the body attaches to an upstream component. When the device is closed, the upstream end of the plunger is in alignment with the upstream flange of the body, forming a steamable sterilized in place face and a sterile barrier.