Aseptic Transfer Device with Rotating Crown Lock

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Solution Overview

Problem

Existing aseptic transfer devices for biopharmaceutical products between containers and closed chambers risk contamination when the chamber door is opened, as the non-sterile face of the container comes into contact with the chamber atmosphere, breaking sterility.

Innovation Solution

A tight connection device with stationary temporary clamping, unlocking, and locking means, actuated by an annular functional crown, ensures aseptic transfer by preventing the chamber door from opening unless a container is properly clamped, using immobilizing/release means to maintain sterility and prevent contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the chamber door is opened to allow container removal, then the productivity of the aseptic transfer process is improved, but the sterility of the biopharmaceutical product is compromised due to contact between the non-sterile face and chamber atmosphere

Engineering Contradiction:

Improvetransfer efficiencyVSAvoidcontamination risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The device segments the sealing function into two independent parts: the container cover seals the container opening, and the chamber door seals the chamber opening. Both can be opened simultaneously to create a shared sterile space, allowing container removal without exposing the product to non-sterile environment. This segmentation resolves the contradiction by enabling productivity improvement while maintaining sterility through coordinated operation of separate sealing elements.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device performs preliminary actions by sequentially actuating unlocking means before opening the door. The container cover is first disengaged from the container, then the chamber door is opened. This preliminary preparation ensures that when the door opens, the container is already in a state that prevents contamination, thus improving productivity while maintaining sterility through pre-coordinated operations.

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If the container cover is disengaged to allow aseptic communication, then the ease of operation for product transfer is improved, but the reliability of the sterile seal is reduced

Engineering Contradiction:

Improvetransfer accessibilityVSAvoidseal integrity

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The chamber door acts as an intermediary element between the external environment and the biopharmaceutical product. When the container cover is disengaged for transfer access, the chamber door remains closed to maintain the sterile barrier. This intermediary mechanism allows ease of operation for container manipulation while preserving seal integrity through the door's protective function.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The device employs dynamic sealing where the container cover transitions from a sealed position (engaged with container) to an open position (disengaged), while the chamber door dynamically adjusts to maintain overall sterility. This dynamic operation allows ease of transfer access temporarily while reliability of sterility is maintained through coordinated movement of sealing elements.

Inventive Principle:

Principle #15Dynamics

3Reliability

If multiple locking positions are implemented for the container, then the reliability of aseptic containment is improved, but the device complexity increases

Engineering Contradiction:

Improvecontainment securityVSAvoidmechanism structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The annular functional crown serves multiple functions: it actuates the temporary clamping means, the unlocking means, and the locking means in sequence through a single rotational operation. This multi-functionality achieves reliable containment security through multiple locking positions while reducing device complexity by consolidating control into one universal actuating mechanism rather than separate controls for each function.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS11684913B2Tight connection device for the aseptic transfer of a biopharmaceutical product between a chamber and a container

Publication Date: 2023.06.27 SARTORIUS STEDIM FMT SAS

AI summary

A tight connection device for the aseptic transfer of a biopharmaceutical product includes: a stationary temporary clamping means keeping the container hermetically clamped against the chamber; a stationary unlocking means capable of switching the container from an initial locked position to an intermediate unlocked position; a stationary locking means; and an annular functional crown capable of being rotated to actuate the stationary unlocking means and the stationary locking means of the container. The stationary unlocking means and the stationary locking means are mechanically linked to the annular functional crown and arranged such that the rotation of the annular functional crown and the end locked position. The device further includes stationary immobilising/release means capable of allowing and preventing the annular functional crown to rotate.