External Thermal Sensor for Biopharmaceutical Storage Containers

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Solution Overview

Problem

Existing thermal sensors for biopharmaceutical storage containers lack the ability to accurately monitor the temperature of biopharmaceutical compositions at desired locations within the storage container, especially during freezing and thawing processes, due to limitations in direct measurement and potential for contamination or damage.

Innovation Solution

The use of a thermal sensor system that includes both an external sensor system secured to the exterior surface of the storage container and an internal probe system within the storage container, allowing for the correlation of external temperature data with internal temperature data to accurately determine the temperature of the biopharmaceutical composition at desired locations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If an internal probe system is used to directly measure temperature, then measurement precision is improved, but the risk of contamination and device complexity increase

Engineering Contradiction:

Improvetemperature measurement accuracyVSAvoidcontamination risk

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses the container wall as an intermediary medium to transfer thermal information from the biopharmaceutical composition to the external sensor. The sensor measures temperature through the container wall, eliminating the need for internal probes that could cause contamination. This intermediary approach maintains measurement precision while removing the harmful factor of contamination risk.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If an external sensor system is used to avoid contamination, then reliability is improved, but measurement precision deteriorates due to inability to directly measure internal temperature

Engineering Contradiction:

Improvecontamination-free measurementVSAvoidinternal temperature measurement accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent applies a thermal coupling agent to the external sensor before measurement, which enhances thermal conductivity between the sensor and container wall. This preliminary preparation ensures that the external sensor can accurately capture internal temperature through the wall, achieving measurement precision comparable to internal probes while maintaining reliability.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent replaces the mechanical insertion of internal probes with a non-contact external sensing system. By using thermal conduction through the container wall combined with signal processing algorithms, the system achieves accurate internal temperature measurement without mechanical intrusion, thereby maintaining both reliability and precision.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If multiple sensors are used to improve measurement accuracy, then measurement precision is improved, but device complexity increases

Engineering Contradiction:

Improvetemperature monitoring accuracyVSAvoidsensor system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent divides the measurement task into two segments: an external sensor system for non-intrusive temperature detection and a signal processing system for data correlation and analysis. This segmentation allows the use of simple external sensors while achieving complex measurement objectives through computational methods, thereby improving precision without proportionally increasing device complexity.

Inventive Principle:

Principle #1Segmentation

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 enables accurate and reliable temperature monitoring of biopharmaceutical compositions during freezing, storage, shipping, and thawing processes, reducing the risk of contamination and ensuring the stability and integrity of the biopharmaceuticals.

Implementation Method 1

The sensor is disposed between the body and the exterior surface of the bladder with the sensor in contact with the exterior surface of the bladder. The sensor is configured to determine a temperature of the exterior surface of the bladder

Methodology Applied

Scientific EffectThermal conduction: Conduction (thermal)

Implementation Method 2

The sensor may include a thermally conductive housing in contact with the exterior surface of the bladder

Methodology Applied

Scientific EffectThermal conduction: Conduction (thermal)

Data Source

PatentUS20250195331A1Thermal sensor for biopharmecutical storage containers and methods of correlating thermal sensors

Publication Date: 2025.06.19 SARTORIUS STEDIM NORTH AMERICA INC

AI summary

A storage container for aseptically storing and freezing a biopharmaceutical composition includes a frame, an expandable bladder, and a sensor system. The expandable bladder is supported within the frame having a filled state in which the expandable bladder is configured to hold the biopharmaceutical composition therein. The sensor system is secured to an exterior surface of the bladder. The sensor system is configured to transmit a signal indicative of a temperature of the exterior surface of the bladder which is correlated to a temperature of biopharmaceutical composition at a desired location within the expandable bladder in the filled state thereof.