Single-Use Volumetric Pump With Pinched Lines for Aseptic Dosing
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing volumetric pumps used in pharmaceutical and medical industries face challenges in maintaining high precision for small volumes, compatibility with viscous products, biopharmaceutical products, and aseptic handling, and require extensive cleaning and validation processes, which are time-consuming and inflexible, making them unsuitable for rapid product development.
Innovation Solution
A single-use volumetric pump kit with a sliding piston design, flexible connecting lines, and synchronized pinching mechanisms to ensure aseptic handling and precise volume delivery without check valves, allowing for easy installation and operation in isolators.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional volumetric pumps are used, then high precision for small volumes can be achieved, but cleaning and validation processes become time-consuming and inflexible
Solution Approach 1:
The patent implements a single-use pump system where the pump unit is disposed of after one use and replaced for the next batch. This eliminates the need for cleaning and validation procedures between batches, reducing validation time while maintaining volume precision through the disposable nature of the pump components.
Solution Approach 2:
The pump system is divided into separate components including the pump unit, connecting lines, and container that can be independently disposed of. This segmentation allows each component to be optimized for single-use operation without requiring cleaning or validation, solving the time loss issue while preserving measurement precision.
2Loss of time
If single use pumps are used, then validation time is reduced, but maintaining high precision for small volumes becomes challenging
Solution Approach 1:
The disposable pump unit is designed with a single-action piston mechanism that ensures precise volume delivery in one use. The pump's disposable nature allows for optimized precision design without the constraints of cleaning and validation requirements, achieving both time savings and measurement accuracy.
Solution Approach 2:
The pump design incorporates specific parameter optimizations for single-use operation, including precise piston stroke length, optimized chamber volume, and controlled flow rate through the piston's sliding motion. These parameter changes enable high precision for small volumes while maintaining the single-use advantage of reduced validation time.
3Ease of operation
If check valves are used in the pump, then fluid direction control is improved, but contamination risk increases
Solution Approach 1:
The patent removes the check valve component from the pump system entirely. Instead of using check valves for fluid direction control, the system relies on the piston's reciprocating motion to create pressure differentials that naturally control fluid flow direction, eliminating the contamination risk associated with check valves while maintaining operational effectiveness.
Solution Approach 2:
The mechanical check valve system is replaced with a piston-driven pressure differential system. The piston's reciprocating motion creates suction and pressure phases that automatically control fluid flow direction without requiring separate valve components, thereby reducing contamination risk while maintaining fluid direction control capability.
4Stability of the object's composition
If rigid connecting lines are used, then structural stability is improved, but flexibility and aseptic handling become difficult
Solution Approach 1:
The patent employs flexible connecting lines made of elastomeric materials that can be easily manipulated and connected in aseptic environments. These flexible lines maintain sufficient structural stability to convey fluid while allowing the necessary manipulation and connection operations required for aseptic handling, resolving the contradiction between stability and ease of operation.
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 kit provides high precision and flexibility in handling small volumes, reduces contamination risks, and simplifies installation and operation, thereby enhancing production efficiency and reducing validation times.
Implementation Method 1
volumetric pumps, or positive displacement pumps, to fill individual containers with liquid preparations
Implementation Method 2
the connecting lines are made with a flexible material allowing the line to be obturated upon pinching
Data Source
AI summary
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 wherein the connecting lines are made with a flexible material allowing the line to be obturated upon pinching. A driving system (50) 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 (11) translation.