Reversible Sterile Fluidic Interface for Automated Aseptic Transfer
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Solution Overview
Problem
Current apparatus for biological and biochemical processes require labor-intensive assembly and disassembly, leading to increased labor costs, downtime, and potential human errors in sterilization and documentation, necessitating more efficient and reliable methods for fluidic connections.
Innovation Solution
A system with steam-sterilizable, easily cleanable, and reversible liquid connections that can be made and detached by axial force, maintaining a sealed environment and allowing for robotic attachment and detachment, featuring a fluidic interface with intracavitary and surface cannular protrusions that form steam-tight chambers for sterile fluid transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual assembly and disassembly of fluidic connections is used, then flexibility and ease of setup are improved, but labor intensity, downtime, and potential for human error increase
Solution Approach 1:
The system is divided into separate modules (bioreactor module, processing module, interface components) that can be independently assembled and disassembled. The fluidic interface is segmented into complementary components (protrusions and receptacles) that enable quick, tool-free connection and disconnection, reducing both labor intensity and downtime while maintaining operational flexibility.
Solution Approach 2:
The fluidic connection system transitions from static, permanently connected components to dynamic, reversible connections. The interface allows rapid assembly and disassembly through complementary mechanical features (protrusions fitting into receptacles), enabling the system to adapt quickly between different operational configurations without extensive manual intervention or prolonged downtime.
2Reliability
If manual cleaning and sterilization procedures are followed, then thoroughness can be achieved, but labor costs and complexity increase
Solution Approach 1:
The system employs disposable sterile barriers (films, caps, connectors) that are pre-sterilized and single-use. These components are discarded after a single use, eliminating the need for complex manual cleaning and sterilization procedures while ensuring consistent sterilization quality. The low cost of these disposable components makes this approach economically viable.
Solution Approach 2:
Sterilization is performed in advance during manufacturing of the disposable components rather than at the point of use. The components arrive pre-sterilized and ready for immediate use, eliminating the need for on-site sterilization procedures and reducing both labor requirements and procedural complexity while maintaining high sterilization standards.
3Extent of automation
If reversible fluidic connections are implemented, then automation capability is improved, but connection reliability and leak prevention become more challenging
Solution Approach 1:
The fluidic interface employs asymmetric complementary components (male protrusions with specific geometries matching female receptacles). This asymmetric design ensures proper alignment and secure engagement during automated connection, while the precise geometric match maintains seal integrity. The asymmetric features prevent misalignment and ensure that only correctly oriented components can connect, reliability despite reversibility.
Solution Approach 2:
The system introduces intermediate sealing elements (elastomeric seals, gaskets, films) that mediate between the rigid mechanical connection components. These intermediary sealing elements compensate for minor manufacturing tolerances and ensure reliable fluid-tight seals during automated reversible connections, maintaining connection integrity while enabling automation.
4Adaptability or versatility
If modular portable components are used, then process adaptability is improved, but system footprint and equipment requirements increase
Solution Approach 1:
Multiple functional components are merged into integrated modular units (bioreactor module combining cultivation and harvesting functions, processing module integrating multiple operations). This consolidation reduces the overall equipment footprint while maintaining process adaptability, as each integrated module can be selectively connected or disconnected based on process requirements rather than requiring separate equipment for each function.
Solution Approach 2:
The modular components are designed with universal interfaces and standardized connection protocols that enable them to perform multiple functions across different process configurations. A single module type can be used in various process arrangements by simply changing its connection configuration, reducing the total number of unique components needed and minimizing equipment footprint while maximizing process adaptability.
Data Source
AI summary
Provided herein is a method for sterile fluid transfer. A first array of conduits may be disposed in a first compartment having a planar face with an array of cavities, each containing a cannular protrusion fluidly connected to a conduit. A second array of conduits may be disposed in a second compartment having its own planar face with an array of surface cannular protrusions, each fluidly connected to a conduit in the second array. The method may include sterilizing the lumens of each conduit-protrusion pair; snugly juxtaposing the two planar faces to form an array of steam-tight chambers; introducing a sterilizing gas into the chambers; expelling the sterilizing gas from the chambers; moving each cannular protrusion towards its facing surface protrusion to reversibly form a fluid connection therebetween, while the chamber remains externally sealed, and transferring a fluid across at least one fluidic connection.