Disposable Container Integrity Testing for Sterile Leak Detection

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Solution Overview

Problem

Existing systems for manufacturing biopharmaceuticals using disposable containers face challenges in maintaining sterility during shipment and detecting leaks smaller than 100 um, which can allow contaminants to enter, and there is a lack of comprehensive systems for packaging, shipping, and integrity testing from initial assembly to client receipt.

Innovation Solution

A system for testing the integrity of disposable containers at reduced volume and constant pressure, using a device that constrains the container to maintain surface area for gas flow and detection of leaks, combined with vertical and horizontal deployment systems, anti-foaming devices, detachable coupling devices, and improved impellers to ensure sterility and efficient handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional leak detection methods are used, then the system can detect leaks, but it cannot detect leaks smaller than 100 um

Engineering Contradiction:

Improveleak detection precisionVSAvoidsterility assurance

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent changes the physical parameters of the container by inflating it to a predetermined volume and maintaining internal pressure, which amplifies the effects of small leaks and enables detection at 10 um scale. This parameter change (from deflated to inflated state) transforms the detection capability significantly.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces conventional visual or manual leak detection methods with a pressurized gas flow system that uses gas flow rate measurements to detect leaks. This substitution enables quantitative detection of extremely small leaks through pressure differential measurement rather than manual inspection.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If the container is inflated to full volume for leak testing, then leak detection sensitivity is improved, but the container requires more space during shipping

Engineering Contradiction:

Improveleak detection sensitivityVSAvoidshipping volume

Core Design Contradiction:

Measurement precisionVSVolume of stationary object

Solution Approach 1:

The patent performs leak detection as a preliminary action before shipping, when the container is in its inflated state at the manufacturing site. After testing, the container is deflated for compact shipping. This preliminary action sequence resolves the contradiction by separating the testing phase (inflated) from the shipping phase (deflated).

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent makes the container volume dynamic rather than static - inflating it for testing and deflating it for shipping. This dynamic volume adjustment allows the same container to occupy different volumes at different stages of its lifecycle, resolving the space contradiction.

Inventive Principle:

Principle #15Dynamics

3Reliability

If comprehensive integrity testing systems are implemented, then container integrity assurance is improved, but the system complexity increases

Engineering Contradiction:

Improvecontainer integrity assuranceVSAvoidtesting system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent creates a multi-functional system that combines sterilization, volume inflation, pressure maintenance, and leak detection into a single integrated apparatus. This universal system performs multiple functions sequentially, reducing the need for separate dedicated devices for each function and managing complexity through integration.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system uses the container's own structure and properties (its walls, ports, and geometry) as part of the testing mechanism. The container itself serves as the test subject and partially as the test apparatus, reducing the need for external complex testing equipment.

Inventive Principle:

Principle #25Self-service

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 system provides high assurance of container integrity by detecting leaks as small as 10 um, ensuring sterility during shipment and use, and facilitating efficient deployment and handling of disposable containers.

Implementation Method 1

The container is inflated with gas to a predetermined volume and pressurized

Methodology Applied

Scientific EffectGas inflation and pressurization: Pressurisation

Implementation Method 2

The filter maintains sterility within, and allows gas to enter, the interior volume of the first container

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Data Source

PatentUS20260078330A1Attachment device for single use containers

Publication Date: 2026.03.19 ABEC INC

AI summary

This disclosure relates to equipment utilized to manufacture chemical agents, particularly biopharmaceuticals, using Disposable Containers (DCs).