Bioreactor Probe Connection System Sterile Interface

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Solution Overview

Problem

Bioreactors face challenges in reliably connecting sensors to flexible, disposable liners without risking contamination or damage, especially in maintaining sterile conditions and avoiding the need for cleanroom environments for probe insertion.

Innovation Solution

A system and method for sterile connection of probes to bioreactors using a probe receiving element with a mounting element, a contaminant barrier for sterilant gas admission, and coupling elements that allow probe insertion through the vessel wall, enabling sterile operation outside a cleanroom.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sensor probes are inserted directly through the flexible disposable liner material, then sensor connection is achieved, but leakage and contamination risk increases due to the non-rigid character of the liner

Engineering Contradiction:
Improveconnection reliabilityVSAvoidcontamination risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A rigid or semi-rigid probe receiving element is introduced as an intermediary component between the flexible disposable liner and the sensor probe. This receiving element provides a stable, pre-sterilized interface that maintains sealing integrity while allowing probe insertion, thus eliminating the contamination risk associated with direct probe insertion through flexible material.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system is divided into separate functional components: the disposable liner, the probe receiving element, and the sensor probe. The probe receiving element can be pre-sterilized and attached to the liner, while the probe is inserted separately, allowing each component to be optimized for its specific function and sterilization requirements.

Inventive Principle:
Principle #1Segmentation

2Productivity

If probe insertion is performed outside a cleanroom environment, then operational efficiency is improved, but sterile conditions may be compromised

Engineering Contradiction:
Improveoperational efficiencyVSAvoidsterility maintenance
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The probe receiving element is pre-sterilized and attached to the disposable liner before probe insertion. This preliminary sterilization action allows the probe to be inserted outside the cleanroom environment while maintaining sterile conditions, as the critical interface is already sterilized and sealed.

Inventive Principle:
Principle #10Preliminary action

3Device complexity

If traditional probe insertion methods are used with flexible liners, then device simplicity is maintained, but probe damage risk increases due to the flexible, non-rigid material

Engineering Contradiction:
Improvesystem simplicityVSAvoidprobe protection
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The probe receiving element serves as a protective intermediary that provides mechanical support and structural integrity during probe insertion. This element protects the fragile sensor probe from damage by the flexible liner material while maintaining the overall simplicity of the disposable bioreactor system.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 ensures reliable, sterile, and leak-proof connections of sensors to bioreactors, reducing the risk of contamination and damage, and eliminates the need for cleanroom insertion, enhancing bioreactor operation efficiency and batch consistency.

Implementation Method 1

a contaminant barrier material adapted to admit a sterilant gas or vapor into an interior volume of said probe receiving element

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentEP2167637B1Bioreactor probe connection system
Publication Date: 2016.08.10 PALL TECHNOLOGY UK LTD
  • EP2167637B1 patent drawingFigure 1
  • EP2167637B1 patent drawingFigure 2
  • EP2167637B1 patent drawingFigure 3A~3B

AI summary

A system providing a sterile connection between a sensor probe and a fluid processing apparatus (e.g., a bioreactor) includes a first probe receiving element mountable to the fluid processing apparatus and a second probe receiving element having a gas-permeable contaminant barrier material and coupleable to the first probe receiving element. A sensor probe may be mounted to the second probe receiving element, with the combination being sterilized with a sterilant gas such as steam. Following such sterilization, connection between the first and second probe receiving elements is made through matable sterile couplings, and the probe is insertable through the coupled receiving elements to a position in fluid contact with the interior of the fluid processing apparatus.