Flexible Bag Safety Device for Biopharmaceutical Mixing Systems

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Solution Overview

Problem

Single-use mixing and storage systems in biopharmaceutical processes are prone to pressure-related issues, such as leakage or bursting due to overfilling or blocked vent filters, which can lead to contamination, financial loss, and safety risks for personnel handling toxic media.

Innovation Solution

A safety device comprising a flexible bag supported in multiple directions with a detection unit to monitor expansion in a defined direction, triggering a safety measure when pressure exceeds a threshold, such as interrupting filling or activating an alarm, using either contact or contactless sensors like photoelectric sensors or mechanical switches.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional pressure sensor is installed in the single-use bag, then overpressure can be detected, but the device complexity increases and the probability of failure increases

Engineering Contradiction:

Improveprobability of failureVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces an intermediary detection unit that indirectly measures bag expansion through optical or mechanical means rather than directly measuring pressure inside the bag. This mediator approach eliminates the need for intrusive pressure sensors, reducing failure points while maintaining detection capability.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces mechanical pressure sensors with optical detection systems (light beams, photoelectric sensors) or simple mechanical switches that detect bag expansion externally. This substitution eliminates complex pressure measurement mechanisms while achieving the same safety function through expansion monitoring.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If a single-use pressure sensor is used in the bag, then overpressure detection is achieved, but the cost efficiency decreases due to single-use disposal

Engineering Contradiction:

Improveoverpressure detectionVSAvoidcost efficiency

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The detection unit and support structure are designed as reusable components that can monitor multiple single-use bags throughout their service life. This multi-functionality allows the same safety system to be applied repeatedly across different bags and applications, eliminating the need for disposable sensors and significantly improving cost efficiency.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent separates the single-use bag from the reusable detection system. While the bag is discarded after one use, the detection unit and support structure are recovered and reused for subsequent bags. This recovery approach maintains overpressure detection capability while eliminating the waste and cost associated with disposable sensors.

Inventive Principle:

Principle #34Discarding and recovering

3Stability of the object's composition

If the bag is supported in all directions rigidly, then mechanical stability is improved, but the bag cannot expand when overpressured

Engineering Contradiction:

Improvemechanical stabilityVSAvoidoverpressure damage

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The support structure employs asymmetric support with gaps or reduced constraint in specific directions (typically the vertical or expansion direction). This asymmetric design provides rigid support for stability during normal operation while allowing controlled expansion when overpressure occurs, directing the expansion in a safe, monitored direction.

Inventive Principle:

Principle #4Asymmetry

Solution Approach 2:

The support structure is segmented with deliberate gaps or separation zones that allow localized expansion in specific directions while maintaining overall structural stability. These segmented regions enable the bag to expand safely without compromising the mechanical integrity of the entire system.

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

The safety device effectively prevents bag damage from overpressure, ensuring operational safety and reducing long-term costs by being reusable and highly sensitive, while also monitoring expansion for freezing or thawing processes.

Implementation Method 1

a detection unit adapted to detect an expansion of the bag in the expansion direction

Methodology Applied

Scientific EffectPosition detection:

Implementation Method 2

using either contact or contactless sensors like photoelectric sensors

Methodology Applied

Scientific EffectPhotoelectric effect: Photoelectric Effect

Data Source

PatentUS12179163B2Safety device for a single-use mixing or storage system

Publication Date: 2024.12.31 SARTORIUS STEDIM BIOTECH GMBH

AI summary

A safety device for a single-use mixing or storage system (10), especially for use in a biopharmaceutical process, includes a flexible bag (12) made from a film material and a support structure (14) receiving and supporting the bag (12) in several directions. The support structure (14) allows an expansion of the bag (12) in an expansion direction. The safety device further includes a detection unit (20) adapted to detect an expansion of the bag (12) in the expansion direction, and a control unit (28) connected to the detection unit (20) and adapted to initiate a safety measure in response to the expansion of the bag (12) in the expansion direction that exceeds a given threshold.