Single-use manifold with pinch valves for aseptic bioprocessing
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Solution Overview
Problem
Current systems for transferring and processing biological and chemical fluids in pharmaceutical and biotech industries require extensive cleaning validation and operator intervention, leading to high costs and potential contamination risks due to the need for frequent cleaning and validation of equipment, especially diaphragm valves and lack of suitable sensors.
Innovation Solution
The development of automated, aseptic manifold systems with presterilized, single-use plastic tubing and disposable conductivity sensors that incorporate remotely operated pinch valves, allowing for automated and precise fluid transfer and dispensing, reducing the need for manual operation and cleaning validation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If presterilized single-use plastic tubing and bags are used for manual solution transfer, then cleaning validation costs and time are reduced, but operator interaction and time are still required with dependent accuracy and precision on operator expertise
Solution Approach 1:
The patent replaces manual mechanical operation (peristaltic pump control, manual clamp operation) with an automated peristaltic pump system that has programmable controllers. The pump can be controlled to dispense precise volumes automatically, eliminating the need for operator expertise while maintaining accuracy and precision in solution transfer.
2Extent of automation
If diaphragm valves are used in automated fluid dispensing systems, then automation capability is improved, but contamination risk increases and cleaning validation costs increase
Solution Approach 1:
The patent extracts the valve function from the fluid path by using external pinch valves that clamp onto the tubing rather than having diaphragm valves inside the fluid path. This removes the contamination source while maintaining automated control capability through external actuation mechanisms.
Solution Approach 2:
The patent introduces an intermediary approach by using peristaltic pumping where the pump rollers compress the tubing to move fluid, rather than using direct contact valves. The pump mechanism acts as an intermediary that moves fluid without requiring valves inside the sterile pathway, eliminating contamination risk.
3Extent of automation
If conventional automated dispensing systems are used, then automation is improved, but suitable sensors especially conductivity sensors are lacking
Solution Approach 1:
The patent creates a universal sensor interface system where multiple sensor types (conductivity sensors, pH sensors, UV detectors) can be connected to the same manifold system through standardized connections. The system architecture allows any sensor to be integrated into the fluid pathway, providing versatility and adaptability for different measurement requirements.
Data Source
AI summary
Presteralized manifolds are provided which are designed for sterile packaging and single-use approaches. Disposable tubing and flexible-wall containers are assembled via aseptic connectors. These manifolds interact with valves and pumping equipment which can be operated by a controller which provides automated and accurate delivery of biotechnology fluid. The manifold also being used in conjunction with one or more conductivity sensors used to measure the conductivity of the biotechnology fluid. Such sensors interact with the controller or are connected to a separate user interface. The combination of disposable tubing, flexible-wall containers, aseptic connectors, manifold, controller, and conductivity sensors provides an aseptic environment while avoiding or reducing cleaning and quality assurance procedures.