Cell Harvesting Instrument With Isolated Pumps for Aseptic Processing
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Solution Overview
Problem
Existing cell harvesting systems fail to provide high-quality cell samples with reduced impurities and preservatives, particularly in small-scale, aseptic conditions, and are not cost-effective or easy to operate and maintain.
Innovation Solution
A cell harvesting instrument with a reusable mechanical system and disposable processing kit that maintains sterility by isolating mechanical parts from fluid contact, using a peristaltic pump and pinch valve to manage fluid flow and a weighing mechanism for volume control, ensuring efficient concentration and washing of cells.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If mechanical parts are used to handle fluids in cell harvesting systems, then fluid flow control and pumping functions are achieved, but sterility is compromised due to contact between mechanical parts and fluids
Solution Approach 1:
The system is divided into sterile and non-sterile zones. The processing kit containing fluids and cells is separated from the mechanical pump components. The pump handles only non-sterile buffer solutions, while sterile fluids remain confined to the disposable processing kit, eliminating cross-contamination risks while maintaining functional fluid handling.
Solution Approach 2:
A non-sterile buffer solution acts as an intermediary medium between the mechanical pump and the sterile cell suspension. The pump circulates this buffer to drive fluid flow through the processing kit, enabling mechanical fluid handling without direct contact between mechanical parts and sterile cellular materials.
2Manufacturing precision
If extensive washing and concentration cycles are performed to remove impurities and preservatives, then cell quality is improved, but processing time increases
Solution Approach 1:
The processing kit is pre-configured with optimized washing and concentration parameters before use. The system performs rapid concentration cycles that achieve effective cell harvesting in fewer steps compared to traditional methods, reducing overall processing time while maintaining quality standards through pre-optimized protocols.
Solution Approach 2:
The system implements continuous circulation and processing cycles that eliminate idle time between washing and concentration steps. Fluids continuously flow through the processing kit, allowing overlapping operations and maintaining constant productive action throughout the cell harvesting process, thereby reducing total turnaround time.
3Reliability
If disposable processing kits are used to maintain sterility, then aseptic conditions are ensured, but operational costs increase
Solution Approach 1:
The system separates disposable sterile components (processing kit) from reusable expensive components (pump, valve, housing). Only the essential fluid-contact portion is disposable, while the expensive mechanical infrastructure is reused across multiple runs, reducing overall operational costs compared to completely disposable systems.
Solution Approach 2:
The reusable mechanical platform with pump, valve, and housing can process multiple different cell types and applications by simply replacing the disposable processing kit. This multi-functional capability amortizes the high initial cost of the mechanical system across numerous uses, reducing the per-operation cost while maintaining sterility for each run.
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 system achieves high-quality cell harvesting with reduced impurities and preservatives, ensuring aseptic conditions, lowering operational costs, and reducing turnaround times for therapeutic applications.
Implementation Method 1
a peristaltic pump and pinch valve to manage fluid flow
Implementation Method 2
a weighing mechanism for volume control
Data Source
AI summary
Disclosed herein is a cell harvesting instrument suitable for concentrating cells from a source suspension of cells and/or washing said cells, the instrument comprising: a housing for accommodating mechanical elements including at least one fluid pump, at least one valve; and a processing kit removably insertable into the housing, said kit including a generally flat frame having or supporting plural sealed fluid paths arranged in a generally flat plane and such that fluids in the paths do not contact said mechanical elements, wherein at least portions of the fluid paths comprise flexible tubes, the outer surfaces of which are manipulatable by the or each fluid pump, to provide fluid flow in one or more of the paths and/or by the or each valve to restrict fluid flow in one or more of the paths. In an embodiment, the kit comprises also a fluid processing reservoir and a filter suitable for separating cells from fluid in said paths. A transfer mechanism for moving and weighing the fluid processing reservoir is disclosed also.