Aseptic Sampling Flow Path Kit with Germicidal Unit
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Solution Overview
Problem
Conventional sampling systems in sterile environments face contamination risks when abnormalities occur in the mechanism for delivering samples from a sterile environment to a non-sterile environment, potentially allowing bacteria to enter the sterile space.
Innovation Solution
An aseptic sampling flow path kit and apparatus with a one-way valve and a germicidal flow path that uses heat or ultraviolet rays, integrated with a fluid detecting unit and CPU for automatic germicidal unit operation in case of flow abnormalities, ensuring sterility is maintained within the isolator.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a one-way valve is provided to limit liquid flow to unidirectional flow from the inside to the outside of the isolator, then sterility inside the isolator is maintained, but the risk of bacterial contamination increases when pump abnormalities occur
Solution Approach 1:
A germicidal unit is introduced as an intermediary component in the flow path between the sterile and non-sterile environments. This unit acts as a mediator that eliminates bacteria in the liquid phase, allowing the one-way valve to maintain sterility while the germicidal unit prevents contamination even when pump abnormalities occur.
Solution Approach 2:
The germicidal unit performs preliminary sterilization of the liquid before it passes through the one-way valve. By pre-treating the liquid to eliminate bacteria, the system ensures that even if the pump malfunctions and allows reverse flow, no bacteria can enter the sterile environment.
2Productivity
If a sampling system with pump mechanism is used to deliver samples from sterile to non-sterile environment, then sampling efficiency is improved, but the complexity of the system increases
Solution Approach 1:
The mechanical pump system is supplemented with a germicidal unit that uses ultraviolet rays or heat to eliminate bacteria. This substitution reduces reliance on complex mechanical sealing mechanisms by introducing a chemical/radiation-based sterilization method, thereby maintaining sampling efficiency while managing system complexity.
3Object-affected harmful factors
If the germicidal unit is automatically activated upon detecting flow abnormalities, then contamination prevention is enhanced, but the energy consumption increases
Solution Approach 1:
A fluid detecting unit monitors the flow status and provides feedback to the control unit. When abnormal flow is detected, the control unit activates the germicidal unit. This feedback mechanism ensures the germicidal unit operates only when necessary, preventing contamination while minimizing unnecessary energy consumption during normal operation.
Solution Approach 2:
The germicidal unit operates periodically based on flow detection rather than continuously. It activates only when flow abnormalities are detected and remains inactive during normal operation, thereby enhancing contamination prevention while reducing overall energy consumption compared to continuous operation.
Data Source
AI summary
An aseptic sampling flow path kit to be applied to an isolator having a liquid delivery port includes a sampling section, a first flow path that communicates with the sampling section, and that connects an inside of the isolator to an outside of the isolator through the liquid delivery port, and at least one one-way valve which is disposed in the first flow path, and that limits flow of fluid in the first flow path to a direction from the sampling section toward the liquid delivery port. In the kit, at least a part of the first flow path is a germicidal flow path to which a germicidal unit is applicable.