Reversible Flow Tubing Decontamination for Containment Systems
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Solution Overview
Problem
Current methods for in-situ filter certification in containment systems are costly and time-consuming, requiring facility shutdowns and extensive decontamination processes, which disrupt ongoing research or production and are inefficient in ensuring complete decontamination of tubing networks.
Innovation Solution
A reversible flow test system that uses a flow reverser with valves to control the direction of sterilization agents through the system, creating optimal humidity and pressure gradients for effective decontamination, allowing for filter certification without shutting down the facility and reducing decontamination time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional decontamination methods are used to ensure complete sterilization of containment systems, then decontamination effectiveness is improved, but facility downtime and loss of research/production time increase significantly
Solution Approach 1:
The system divides the decontamination process into separate pathways: a first pathway allows aerosol challenge and sampling to proceed independently, while a second pathway handles decontamination agent circulation. This segmentation enables decontamination to occur during filter testing without requiring complete facility shutdown, thereby reducing downtime while maintaining decontamination effectiveness.
Solution Approach 2:
The system pre-establishes multiple flow pathways and positioning systems before decontamination begins. The adjustable positioning system is pre-configured to control aerosol generation, sampling, and decontamination agent flow, allowing the facility to maintain operational status during decontamination processes rather than requiring sequential operations.
2Object-affected harmful factors
If decontamination is performed before filter testing, then safety is improved, but the complexity and time required for the overall process increases
Solution Approach 1:
The system employs a multi-functional adjustable positioning system that serves multiple purposes: controlling aerosol challenge flow, positioning sampling devices, and directing decontamination agent flow through the same containment system. This universal system handles both testing and decontamination functions without requiring separate dedicated equipment, thereby managing complexity while ensuring safety.
Solution Approach 2:
The system enables continuous operation by allowing decontamination to proceed simultaneously with filter testing through separate pathways. The adjustable positioning system continuously controls both the testing aerosol flow and decontamination agent circulation without interruption, eliminating the need to stop testing for decontamination and reducing overall process complexity.
3Reliability
If higher concentrations of decontaminant agents are used to ensure complete decontamination of tubing networks, then decontamination effectiveness is improved, but agent consumption and cost increase
Solution Approach 1:
The adjustable positioning system directs decontamination agents to specific locations within the containment system where they are most needed, rather than uniformly distributing them throughout. The system can position sampling devices and control aerosol flow locally, allowing concentrated decontamination effort in critical areas such as tubing networks and filter interfaces, thereby improving decontamination completeness while reducing overall agent consumption.
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 efficient and effective decontamination of containment systems, reducing downtime and decontamination agent usage, while maintaining operational conditions for filter certification without prior facility decontamination, thus minimizing lost research or production time and costs.
Implementation Method 1
operating a vacuum pump to create a flow of sterilization or decontamination agent in a test system in a first flow direction
Implementation Method 2
reversing the flow direction of the agent in the test system
Data Source
Figure 1
Figure 2A~2B
Figure 2C~2D
AI summary
Embodiments of the invention generally provide an apparatus and method for decontaminating tubing. The invention is particularly suitable for decontaminating tubing in a test system used for certifying a filter in a containment system. In one embodiment, a test system for a containment system is provide that includes a sample system including equipment adapted for testing a filter disposed in a containment system utilizing samples obtained from a downstream sample port and a upstream sample port of the containment system, and a device for reversing a flow within the sample system. In another aspect of the invention, a method for decontaminating tubing is provided. In another embodiment, the method includes flowing a sterilization agent through tubing in a first direction and flowing the sterilization agent through tubing in a second direction.