Vacuum Integrity Testing for Embossed Film Bioprocessing Containers

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Solution Overview

Problem

Traditional integrity testing methods for flexible bioprocessing containers, especially larger ones, are limited by material stretching, false readings due to film expansion, and inability to detect small defects, leading to potential contamination and economic loss.

Innovation Solution

A vacuum-based integrity test using containers with embossed or textured internal surfaces to maintain separation between walls, allowing air flow detection of defects through mass flow monitoring, suitable for containers of various sizes and configurations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If pressure decay testing is used on larger flexible containers, then the testing method remains consistent across container sizes, but the container material experiences excessive strain and hoop stress that can cause bursting or false readings

Engineering Contradiction:

Improvetesting method consistencyVSAvoidcontainer material strength

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The patent inverts the traditional pressure decay approach by using vacuum decay instead. Rather than pressurizing the container to detect leaks, the system evacuates the container to a vacuum state and monitors for pressure changes. This reversal eliminates the hoop stress problem because vacuum testing applies compressive forces that flexible materials can withstand without bursting, while still detecting microscopic defects through sensitive pressure monitoring.

Inventive Principle:

Principle #13The other way round (Inversion)

2Device complexity

If traditional pressure testing is used on flexible containers, then the testing process is simple, but the film material stretches and expands causing false readings and reduced measurement precision

Engineering Contradiction:

Improvetesting process simplicityVSAvoiddefect detection accuracy

Core Design Contradiction:

Device complexityVSMeasurement precision

Solution Approach 1:

The patent applies vacuum decay testing instead of pressure testing. By evacuating the container to a vacuum and monitoring for pressure changes, the system avoids film stretching and expansion that occur during pressurization. This inversion allows for more accurate defect detection because the flexible material remains in its natural state without distortion, eliminating false readings while maintaining operational simplicity.

Inventive Principle:

Principle #13The other way round (Inversion)

3Productivity

If visual inspection is used to detect defects, then the method is simple and quick, but it cannot detect microscopic holes or tears that pose greater contamination risk

Engineering Contradiction:

Improveinspection speedVSAvoiddefect detection sensitivity

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The patent replaces visual inspection with a physical vacuum decay testing method. Instead of relying on human vision to detect defects, the system uses pressure sensors to monitor for vacuum loss caused by microscopic leaks. This substitution enables detection of tiny holes and tears that are invisible to the naked eye, significantly improving defect detection sensitivity while maintaining rapid testing capability through automated pressure monitoring.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 method provides rapid and sensitive detection of microscopic defects, reducing the risk of contamination and ensuring sterility, applicable to containers of any size or complexity, including those with fittings, and allowing for efficient quality control and reduced handling-induced defects.

Implementation Method 1

A vacuum-based integrity test using containers with embossed or textured internal surfaces to maintain separation between walls, allowing air flow detection of defects through mass flow monitoring

Methodology Applied

Scientific EffectVacuum: Vacuum

Implementation Method 2

allowing air flow detection of defects through mass flow monitoring

Methodology Applied

Scientific EffectMass flow:

Data Source

PatentUS12429397B2Embossed film bioprocessing containers and integrity testing of bioprocessing containers

Publication Date: 2025.09.30 EMD MILLIPORE CORP

AI summary

A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.