Single-Use System Leak Testing with Infrared Gas Imaging
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Solution Overview
Problem
Existing integrity testing methods for single-use systems in pharmaceutical manufacturing are limited by the need for large testing chambers, inability to test integrated systems, low sensitivity for small leaks, and inability to distinguish between small and large leaks, leading to potential microbial contamination risks.
Innovation Solution
A method using an infrared camera to monitor the application of a test gas with infrared spectral properties within the single-use system, allowing for detection of leaks down to 5-10 μm in diameter by detecting temperature differences between the test gas and ambient air.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pressure tests are used for integrity testing of single-use systems, then leakage detection capability is provided, but the plastic components are damaged or deformed due to high mechanical stress
Solution Approach 1:
The patent replaces the mechanical pressure testing system with an optical detection system. Instead of applying mechanical pressure to force gas through leaks, the system uses an infrared camera to detect temperature differences caused by gas flow at leak sites. This substitution eliminates the damaging mechanical stress while maintaining leakage detection capability.
Solution Approach 2:
The patent changes the detection parameter from pressure-based to temperature-based detection. By monitoring temperature differences in the infrared spectrum rather than mechanical pressure, the system can detect leaks without applying high stress to the plastic components, thus preserving their structural integrity.
2Adaptability or versatility
If large testing chambers are used for integrity testing, then complete system testing is enabled, but the device complexity and cost increase significantly
Solution Approach 1:
The patent extracts the detection function from a large testing chamber environment and implements it using a portable infrared camera system. This allows integrity testing to be performed in-situ at the actual processing location without requiring complex chamber infrastructure, thereby reducing device complexity while maintaining complete system testing capability.
Solution Approach 2:
The system enables self-service integrity testing by using the infrared camera to detect leaks directly on the single-use system components without requiring external testing chambers or complex infrastructure. The components can be tested in their actual operating environment, eliminating the need for separate testing facilities.
3Reliability
If conventional detection methods are used, then leakage detection is provided, but the sensitivity for small leaks below 30 μm is insufficient
Solution Approach 1:
The patent utilizes thermal radiation detection in the infrared spectrum, where leak sites appear as distinct thermal signatures or 'color' changes in the infrared image. This allows detection of small leaks by identifying temperature differences rather than relying on pressure changes, significantly improving measurement precision for leaks below 30 μm.
Solution Approach 2:
The patent applies gas flow to create movement and turbulence at leak sites, which generates detectable thermal patterns. The flowing gas creates characteristic temperature distributions that enhance the visibility of small leaks in infrared images, improving detection sensitivity without requiring high pressure.
4Quantity of substance
If pressure-based testing is used, then total leakage is measured, but the ability to distinguish between multiple small leaks and large leaks is lost
Solution Approach 1:
The patent segments the leakage detection into spatially resolved individual leak sites using infrared imaging. Instead of measuring total gas flow that aggregates all leaks, the system creates separate thermal signatures for each leak location, allowing differentiation between multiple small leaks and single large leaks while still providing quantitative information about each individual leak.
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
Enables high-sensitivity, cost-effective integrity testing of single-use systems without damaging them, capable of detecting small leaks and distinguishing between multiple small leaks and large leaks, ensuring sterility and preventing microbial ingress.
Implementation Method 1
monitoring at least a part of the single-use system by using an infrared camera
Implementation Method 2
detecting temperature differences between the test gas and ambient air
Implementation Method 3
the test gas has one or more of spectral absorption or spectral emission properties in the infrared spectral range being distinguishable from ambient air
Implementation Method 4
the test gas has one or more of spectral absorption or spectral emission properties in the infrared spectral range
Data Source
AI summary
Disclosed is a method of integrity testing of a single-use system for processing a fluidic material. In the inventive method, a single-use system for processing at least one fluidic material is provided. The single-use system has at least one plastic component. A test gas is applied to a lumen of the single-use system. The test gas has one or more of spectral absorption or spectral emission properties in the infrared spectral range distinguishable from ambient air. At least a part of the single-use system is monitored using an infrared camera. A method of processing a fluidic material by using a single-use system and a test system for integrity testing of a single-use system are also disclosed.