Severable Fluid Transfer Connector for Aseptic Disconnection

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Solution Overview

Problem

In biopharmaceutical and pharmaceutical manufacturing, maintaining an aseptic environment during fluid transfer between closed processing systems is challenging, particularly when disconnecting sample collection vessels from tanks, as existing solutions fail to prevent contamination upon separation.

Innovation Solution

A connector system comprising a rigid conduit with a flexible tube surrounded by a deformable sleeve, capable of being sealed and severed while maintaining pressure integrity, using materials like aluminum or stainless steel for the sleeve and thermoplastic elastomer tubing for the flexible tube, with adhesives like platinum-catalyzed silicone to ensure aseptic separation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the sample collection vessel is disconnected from the tank, then the sample can be separated for analysis, but the fluid pathway becomes exposed to the environment causing contamination risk

Engineering Contradiction:

Improveability to disconnect sample collection vesselVSAvoidcontamination from ambient air exposure

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The deformable sleeve is pre-positioned around the flexible tube before disconnection occurs. When the fitting is disconnected, the sleeve is deformed to seal the tube end in advance, preventing ambient air contamination before the fluid pathway is fully exposed to the environment.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The deformable sleeve acts as an intermediary sealing element between the flexible tube and the ambient environment. It provides a mechanical barrier that prevents direct exposure of the fluid pathway to contaminants during the disconnection process.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Adaptability or versatility

If the connector is designed to be separable, then the sample collection vessel can be removed, but maintaining pressure integrity and preventing leakage becomes difficult

Engineering Contradiction:

Improveseparability of connector componentsVSAvoidpressure containment and leak prevention

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The deformable sleeve functions as a flexible sealing shell that can be deformed to create a pressure-tight seal around the flexible tube. This flexible membrane approach allows the connector to be separable while maintaining pressure integrity, as the sleeve can be deformed to seal the tube end during disconnection.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The deformable sleeve changes its physical state from an open configuration to a sealed configuration through deformation. This parameter change in the sleeve's shape and volume allows it to transition from allowing fluid flow to preventing leakage, ensuring pressure containment during separation.

Inventive Principle:

Principle #35Parameter changes

3Object-affected harmful factors

If a rigid sealing mechanism is used to prevent contamination, then aseptic conditions are maintained, but the device complexity increases

Engineering Contradiction:

Improveprotection against contaminationVSAvoidcomplexity of sealing mechanism

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The deformable sleeve is designed to seal the flexible tube through its own deformation without requiring additional sealing components or complex mechanisms. The sleeve's material properties enable it to self-seal by deforming around the tube, reducing device complexity while maintaining effective contamination protection.

Inventive Principle:

Principle #25Self-service

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 effectively maintains aseptic conditions by sealing the fluid pathway during separation, preventing contamination and withstanding at least 1 bar of pressure without leaking, ensuring the integrity of the fluid transfer process.

Implementation Method 1

the deformable sleeve is formed of a material that has a plasticity such that pressure applied to the deformable sleeve causes the deformable sleeve to deform about and seal the flexible tube

Methodology Applied

Scientific EffectPlasticity: Plasticity

Implementation Method 2

The deformable sleeve may be adhesively attached to the flexible tube

Methodology Applied

Scientific EffectAdhesion: Adhesive

Data Source

PatentUS11660438B2Separable fluid transfer connector

Publication Date: 2023.05.30 SARTORIUS STEDIM NORTH AMERICA INC

AI summary

A connector for facilitating fluid transfer includes first fitting, a second fitting, a rigid conduit, a first retaining connector, and a second retaining connector. The rigid conduit includes a flexible tube surrounded by a deformable sleeve. The rigid conduit is connected on a first end to the first fitting and on a second end to the second fitting. The first retaining connector connects the first fitting to the rigid conduit and the second retaining connector connects the second fitting to the rigid conduit. A lumen extends through the rigid conduit and is capable of being sealed. The rigid conduit and the flexible tube are capable of being severed while maintaining the seal of the lumen to separate the first fitting from the second fitting. The connections of the first fitting and the second fitting to the rigid conduit are capable of withstanding at least 1 bar of pressure without leaking.