Disposable Positive Displacement Pump Rolling Diaphragm Sterility
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Solution Overview
Problem
Existing positive displacement pumps used in sterile operations require manual dis-assembly, cleaning, and sterilization, which adds time and cost, and poses risks of contamination due to wear and frictional issues, compromising the sterility of the fluid during filling operations.
Innovation Solution
A disposable positive displacement pump with a rolling diaphragm and integrally formed head and body, eliminating the need for clean-in-place and sterilize-in-place procedures by being fully sealed and replaceable, ensuring sterility and reducing operational downtime.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual dis-assembly, cleaning and re-assembly of positive displacement pumps is performed, then the pump can be reused, but time is lost and contamination risk increases
Solution Approach 1:
The pump is designed as a disposable single-use device that is discarded after one use, eliminating the need for cleaning and sterilization operations. This resolves the contradiction by accepting the pump as a consumable item rather than attempting to reuse it, thereby maintaining sterility without time loss.
Solution Approach 2:
The pump is designed as a separable assembly with distinct components (pump body, diaphragm, piston drive unit) that can be independently manufactured and sterilized as a complete unit. This allows the entire pump assembly to be pre-sterilized and disposed of after use, avoiding the need for complex in-place sterilization procedures.
2Reliability
If clean-in-place and sterilize-in-place operations are performed, then pump sterility is maintained, but operational time is reduced and cost increases
Solution Approach 1:
By making the pump disposable, the system eliminates the need for clean-in-place and sterilize-in-place operations entirely. The pump is pre-sterilized during manufacturing and discarded after single use, thereby maintaining sterility while maximizing operational efficiency and minimizing downtime.
3Device complexity
If piston drive unit directly contacts fluid chamber, then simpler structure is achieved, but frictional wear causes fluid contamination
Solution Approach 1:
A diaphragm is introduced as an intermediary element between the piston drive unit and the fluid chamber. The diaphragm transmits the mechanical motion from the piston to the fluid while preventing direct contact between the piston and fluid, thereby eliminating frictional wear and fluid contamination while maintaining a relatively simple pump structure.
4Reliability
If rolling diaphragm is used to separate piston drive unit from fluid chamber, then fluid handling is improved, but pump structure becomes more complex
Solution Approach 1:
The rolling diaphragm serves as an intermediary that provides leakproof sealing while transmitting mechanical motion. Although it adds a component to the pump structure, the diaphragm is a simple flexible membrane that can be easily manufactured and integrated, providing significant benefits in fluid integrity and contamination prevention that outweigh the moderate increase in structural complexity.
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 disposable pump system provides a contamination-free, rapid, and repeatable delivery of fluid volumes without the need for extensive cleaning and sterilization, enhancing operational efficiency and reducing the risk of contamination in sterile applications.
Implementation Method 1
positive displacement pumps generally incorporate a piston driven pump unit that includes a piston, a fluid chamber, and a body. The pump unit is used, in combination with timed valves, to encourage fluid travel through the pump chamber and the tubing
Implementation Method 2
The rolling diaphragm provides a leakproof seal for the fluid within the pump. It also ensures gentle handling of the fluid to be delivered by minimizing the shearing of molecules within the liquid that may otherwise occur using a piston drive unit to drive the liquid
Data Source
AI summary
A disposable positive displacement pump is disclosed. The pump includes a pump housing having head portion and a body, the head portion having one or more fluid passage openings. The pump also includes a rolling diaphragm internal to the pump housing and defining a fluid chamber within the pump housing. The pump further includes a piston drive unit configured to reciprocally drive the rolling diaphragm to move fluid in or out of the fluid chamber. A method of dispensing a fluid is also disclosed.