Disposable Sensor Housing With Sterile Breaking Point

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Solution Overview

Problem

Disposable process sensors in pharmaceutical, biological, and biotechnological applications face challenges such as changes in sensor characteristics due to sterilization and storage, leading to inaccurate measurements and the need for efficient calibration, especially after gamma radiation sterilization, which can damage electronic components.

Innovation Solution

A sensor arrangement is integrated into a housing with a predetermined breaking point within a disposable container, allowing for protection from environmental influences and storage under damp conditions, enabling quicker commissioning and calibration by establishing a connection with the process medium through controlled pressure changes or medium introduction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sensors are integrated into disposable containers and sterilized together with the container, then cross-contamination is prevented and process reliability is increased, but sensor properties change causing zero-point drift and measurement inaccuracy

Engineering Contradiction:

Improveprocess reliabilityVSAvoidsensor measurement accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The sensor system is divided into two separate parts: a sterilizable sensor unit that can be sterilized with the disposable container, and a non-sterilizable electronic evaluation unit that remains outside the sterile barrier. This segmentation allows the sensor to be sterilized without exposing electronic components to gamma radiation, preventing both cross-contamination and sensor degradation.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A sterile barrier (sterile seal) is introduced as an intermediary between the sterilizable sensor unit and the non-sterilizable electronic unit. This barrier allows electrical signals to pass through while preventing contamination and protecting electronic components from sterilization processes. The sterile seal enables the sensor to be sterilized independently without affecting the electronic evaluation unit.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If sensors are sterilized by gamma radiation to ensure sterile conditions, then cross-contamination is prevented, but electronic components of the sensors are destroyed

Engineering Contradiction:

Improvesterile conditionsVSAvoidsensor functionality

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sensor unit is designed as a disposable component that can be sterilized along with the container and then discarded after use. This eliminates the need to protect expensive electronic components from sterilization, as the sensor unit itself is intended for single use. The electronic evaluation unit can be reused across multiple containers.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Loss of time

If sensors are stored for a longer period after sterilization before commissioning, then logistics flexibility is improved, but sensor properties change requiring recalibration

Engineering Contradiction:

Improvelogistics flexibilityVSAvoidsensor characteristic curves

Core Design Contradiction:

Loss of timeVSMeasurement precision

Solution Approach 1:

The sensor unit is pre-sterilized and stored in a sterile state before use. The sterile seal remains intact during storage, protecting the sensor from environmental influences that would cause drift. Calibration is performed immediately before commissioning by establishing a connection between the sensor and the sterile medium through the breaking point, ensuring accurate measurements from the start of the process.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If potentiometric and amperometric sensors are stored under damp conditions to ensure reliable outputs, then measurement reliability is improved, but storage and handling complexity increases

Engineering Contradiction:

Improvesensor output reliabilityVSAvoidstorage requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The sensor unit is separated from the electronic evaluation unit by a sterile barrier, allowing the sensor to be stored in a damp environment within the sterile container without affecting electronic components. The sterile seal protects the electronic unit from moisture while the sensor unit can be stored under conditions optimal for its operation.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS10260915B2Container with sensor arrangement

Publication Date: 2019.04.16 ENDRESS HAUSER CONDUCTA GMBH CO KG

AI summary

A container for use as a single-use component in a processing system for performing a biological, biochemical, or biotechnological process includes a wall surrounding a container interior space with a sensor arrangement integrated into the wall, where the sensor arrangement includes at least one sensor and one housing, and where the housing includes a housing wall, which surrounds a housing interior space containing the sensor and separates the housing interior space from the container interior space, characterized in that the housing wall comprises a wall region, which is designed as a predetermined breaking point.