Active Diaphragm Vacuum Sealing for Sterile Transfer Valves

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Solution Overview

Problem

Existing active diaphragm systems for sterile transfers in pharmaceutical processes lack control over gasket functionality, leading to potential contamination and batch destruction due to compromised seals during transfers between autoclaves and filling machines.

Innovation Solution

The active diaphragm design incorporates a hollow structure with a suction conduit and aspirator for controlled rotation and sealing, along with a peripheral gasket for compression, and a control circuit to monitor vacuum levels, ensuring effective gasket functionality and sterility maintenance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a passive diaphragm is used for sealing during sterile transfers, then the sealing function is provided, but there is no control over gasket functionality leading to potential contamination

Engineering Contradiction:
Improvegasket functionality controlVSAvoiddiaphragm structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the passive diaphragm sealing function with an active diaphragm control system. The active diaphragm includes a suction conduit connected to a vacuum source, allowing controlled compression of the gasket between the two diaphragms. This merging provides both reliable sealing and active control over gasket functionality, resolving the contradiction between reliability and the need for additional control mechanisms.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent incorporates a control system that monitors the vacuum level in the suction conduit to detect gasket functionality. When the gasket fails to compress properly or becomes contaminated, the vacuum level changes, providing feedback about the sealing status. This feedback mechanism enables real-time monitoring and control of gasket functionality, improving reliability without requiring complete redesign of the diaphragm structure.

Inventive Principle:
Principle #23Feedback

2Productivity

If the active diaphragm rotates to open the valve, then material transfer is enabled, but the gasket may become compromised or contaminated

Engineering Contradiction:
Improvematerial transfer capabilityVSAvoidgasket integrity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies preliminary action by compressing the gasket with the active diaphragm before rotation occurs. The suction conduit creates a vacuum that pulls the active diaphragm against the passive diaphragm, pre-compressing the gasket to ensure sealing integrity. This preliminary compression action prepares the gasket for the subsequent rotation and material transfer, maintaining reliability during productivity-enhancing operations.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent makes the diaphragm system dynamic by enabling rotation of the active diaphragm relative to the passive diaphragm. The active diaphragm can rotate to open the valve for material transfer, while the gasket maintains sealing through the continuous vacuum pressure. This dynamic capability allows the system to switch between sealed and open states, enabling both productivity and reliability.

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If no vacuum control system is implemented, then the device structure remains simple, but seal failures cannot be detected in real-time

Engineering Contradiction:
Improveseal failure detectionVSAvoidcontrol system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent implements a feedback control system where the vacuum level in the suction conduit is continuously monitored. A sensor detects changes in vacuum pressure, providing real-time information about gasket sealing status. When the gasket fails or becomes contaminated, the vacuum level changes, triggering an alarm or shutdown signal. This feedback mechanism enables precise detection of seal failures without requiring complex additional monitoring equipment.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent uses pneumatic principles by implementing a vacuum-based control system. The suction conduit creates a vacuum that serves as both the sealing mechanism and the detection medium. Changes in vacuum pressure directly indicate gasket status, eliminating the need for separate mechanical sensors or complex electronic monitoring systems. This pneumatic approach provides precise measurement with minimal added complexity.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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

This solution allows for real-time detection of seal failures, preventing contamination and ensuring the sterility of product batches by maintaining effective gasket functionality and sealing efficiency during transfers.

Implementation Method 1

a suction conduit (523) adapted to place in communication the hollow (521) with an aspirator (53) external to the diaphragm (52)

Methodology Applied
Scientific EffectVacuum: Vacuum

Data Source

PatentEP3657052B1Improved active/passive diaphragm for a material transfer valve
Publication Date: 2023.05.24 FEDEGARI AUTOCLAVI
  • EP3657052B1 patent drawingFigure 1~3
  • EP3657052B1 patent drawingFigure 4~6
  • EP3657052B1 patent drawingFigure 7~12

AI summary

The present invention relates to an active diaphragm (52; 72; 82) for an active door (51; 71; 81) adapted for the hermetic closure of a conduit, the diaphragm (52; 72; 82) defining a support surface (520; 820) arranged on a plane π1; a geometric axis (a) substantially perpendicular to the plane π1; and an axis of rotation (r) substantially parallel to the plane π1; the diaphragm (52; 72; 82) comprising: a hollow (521; 821), comprised inside the support surface (520; 820); and a suction conduit (523; 823) adapted to place in communication the hollow (521; 821) with an aspirator (53; 73; 83) external to the diaphragm (52; 72; 82). The invention also relates to an active door (51; 71; 81) for the hermetic closure of a conduit and a sterile transfer system comprising an active door (51;71;81) and a passive door (61).