Single-Use Volumetric Pump With Synchronized Line Pinching
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Solution Overview
Problem
Existing volumetric pumps used in sterile environments face issues with leaks due to check valves, leading to contamination risks and prolonged cleaning validation processes, which hinder flexibility and increase time to market.
Innovation Solution
A single-use volumetric pump design that eliminates check valves by using synchronized pinching means to control fluid flow in inlet and outlet lines, ensuring precise fluid displacement without rotation, and is designed for easy installation and operation in isolators.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If check valves are used in the pump, then fluid flow control is achieved, but leaks and contamination risks occur
Solution Approach 1:
The patent removes check valves from the pump system entirely. Instead of using valves to control fluid flow direction, the system uses a flexible connecting line that can be pinched to obtainate (close) fluid flow. This extraction of the problematic component (check valve) eliminates the source of leaks and contamination while maintaining fluid control functionality through an alternative mechanism (pinching means).
Solution Approach 2:
The patent employs a single-use pump system where the connecting line is designed to be disposable. The flexible connecting line can be pinched to close fluid flow and is replaced after each use, eliminating the need for complex, reusable valve mechanisms that are prone to leakage. This disposable approach ensures sterility and prevents contamination between uses.
2Reliability
If check valves are installed in the pump, then fluid circulation is managed, but cleaning validation time increases
Solution Approach 1:
By removing check valves from the system, the patent eliminates components that require extensive cleaning and validation. The simplified system with pinched flexible lines has fewer surfaces and crevices that need validation, significantly reducing cleaning time and allowing faster turnover between production batches.
Solution Approach 2:
The system uses disposable connecting lines that are discarded after single use rather than cleaned and validated repeatedly. This eliminates the time-consuming cleaning and validation process entirely for these components, while the pump body itself can be quickly prepared for the next use.
3Reliability
If pinching means are applied only on the outlet line, then inadvertent delivery is prevented, but additional control over inlet flow is limited
Solution Approach 1:
The patent extends the pinching means to control both the inlet and outlet connecting lines, making the same type of control mechanism universal for both fluid entry and exit points. This multi-functional approach provides complete control over fluid circulation, allowing the system to prevent inadvertent delivery at the outlet while also controlling inlet flow, thereby enhancing overall versatility.
Solution Approach 2:
The system uses dynamic pinching control where the degree and timing of pinching can be adjusted independently for inlet and outlet lines. This dynamic control allows flexible management of fluid flow at different stages of the pumping cycle, enabling precise adaptation to various operational requirements while maintaining simple mechanism 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 provides high precision and sterility, reducing contamination risks and simplifying validation processes, thereby enhancing operational flexibility and reducing time to market.
Implementation Method 1
pinching means arranged for pinching the outlet connecting line and for managing a fluid circulation in the outlet connecting line
Implementation Method 2
a pump with a piston slidingly arranged within a cylinder body... the other extremity of the piston is protruding from the cylinder body... mobile arm arranged to hold said other extremity of the piston and for driving a reciprocal translation of said piston
Data Source
Figure 1~2
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AI summary
The invention relates to new single use volumetric pump meeting the stringent requirements for use in sterile environments like in the pharmaceutical and/or biomedical industry. A kit comprising a single action pump 1 with inlet 21 and outlet 31 connecting lines 2, 3 wherein the connecting lines are made with a flexible material allowing the line to be obturated upon pinching. A driving system adapted to operate the kit is also provided where pinching means are arranged to alternatively pinch the connecting line fastened to the inlet and the connecting line fastened to the outlet in synchronization with the piston translation.