Fluid Isolating Peristaltic Pump for Continuous Bioprocessing
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Solution Overview
Problem
Batch manufacturing processes for complex products like cell and gene therapies are limited by resource intensity and quality control constraints, making it difficult to achieve continuous flow processing and proper incubation of fluids.
Innovation Solution
A fluid isolating peristaltic pump system with a reactor and consumable components, including a rotary seal and roller assemblies, that creates isolated volumes within processing tubing, allowing for continuous flow and controlled incubation of fluids by rotating the consumable within the reactor while maintaining sterility and efficient reactant delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If batch manufacturing is used to ensure quality control and sterility, then product purity and potency are maintained, but resource consumption increases and scalability is limited
Solution Approach 1:
The system implements continuous flow processing where fluids are continuously pumped through processing tubing within a consumable reactor, eliminating the start-stop nature of batch processing. The peristaltic pump maintains continuous fluid movement through the tubing, enabling uninterrupted manufacturing operations that improve resource efficiency while maintaining quality control through consistent flow conditions.
Solution Approach 2:
The system divides the continuous flow into isolated volumes using segmented fluid compartments within the processing tubing. This segmentation allows different fluid portions to be independently controlled and monitored, enabling continuous processing while maintaining the quality control advantages of discrete batch operations through defined fluid boundaries and controlled residence times.
2Productivity
If continuous flow processing is implemented to improve resource efficiency and scalability, then productivity increases, but proper incubation of fluids becomes difficult to achieve
Solution Approach 1:
The system pre-configures the processing tubing with specific path lengths and flow resistance characteristics before operation. By designing the tubing geometry and flow conditions in advance, the system ensures that fluids achieve the required incubation time automatically as they traverse the predetermined path, eliminating the need for separate incubation steps and enabling continuous processing with controlled residence times.
Solution Approach 2:
The system dynamically adjusts flow rates through the peristaltic pump to optimize the balance between continuous processing speed and incubation time requirements. By varying the pump speed and flow conditions, the system can control the residence time of fluids in the processing tubing to match specific incubation requirements while maintaining continuous operation.
3Reliability
If sterile barriers and complex sealing mechanisms are added to maintain sterility in continuous flow, then contamination is prevented, but device complexity increases
Solution Approach 1:
The system employs a disposable consumable containing the processing tubing and reactor components. This single-use approach eliminates the need for complex sterilization and sealing mechanisms by discarding the entire consumable after use, ensuring sterility through manufacturing sterilization rather than operational sealing, and significantly reducing device complexity.
Solution Approach 2:
The processing tubing utilizes flexible elastomeric materials that provide inherent sealing properties through their elasticity and ability to form tight seals against the peristaltic pump rollers and internal structures. This flexible tubing design maintains sterility through material selection and design rather than complex mechanical sealing systems.
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
Enables continuous processing of fluids, reducing resource dependency and improving scalability, while maintaining quality control through precise temperature and time management, thus overcoming the limitations of batch manufacturing.
Implementation Method 1
roller assemblies that assist in the creation of isolated volumes within a processing tubing wrapped around an outside of the consumable as the consumable is rotated within the reactor
Implementation Method 2
The consumable includes a rotary seal that allows for the consumable to be rotated within the reactor by the roller assemblies while still providing reactants to the tubing wrapped around the outside of the consumable
Implementation Method 3
a drum motor. The reactor includes roller assemblies that assist in the creation of isolated volumes within a processing tubing wrapped around an outside of the consumable as the consumable is rotated within the reactor via a drum motor
Data Source
AI summary
A reactor includes a drum motor, and a roller assembly including a roller. The reactor further includes: a roller motor mechanically coupled to the roller assembly, a ring gear mechanically coupled to the roller motor, and a motor balancing system to preload tension into the drum motor belt to synchronize the drum motor and the roller motor. The reactor system further includes a consumable that is insertable into the reactor. The motor balancing system includes a drum motor belt coupled to the drum motor an arm coupled to the drum motor belt, and a spring coupled to the arm. The spring applies a tension force to the drum motor belt.