Sterile Membrane Isolates Non-Sterile Sensors
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Solution Overview
Problem
The integration of non-sterile sensors into a sterile flow stream is complicated due to differing sterilization requirements, leading to increased time and cost, as existing methods necessitate separate sterilization procedures for various system components.
Innovation Solution
A sterile-grade membrane is used to separate the sensor from the sterile flow stream, allowing non-sterile sensors to be interfaced without compromising the sterile environment, by being permanently attached to the flow stream and sterilized with other components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate sterilization procedures are used for different components, then sterilization effectiveness is improved, but process complexity and time increase
Solution Approach 1:
The system divides the sterilization process into two independent segments: (1) sterilization of flow stream components using gamma irradiation or other methods, and (2) separate sterilization of sensors using autoclave or chemical sterilization. This segmentation allows each component type to be sterilized independently using the most appropriate method, avoiding the need for a unified sterilization approach that would compromise either sensors or flow components.
Solution Approach 2:
A sterile barrier (sterile adapter or membrane) is introduced as an intermediary between the sterilized flow stream and the sensor. This barrier maintains sterile isolation while allowing the sensor to remain outside the sterile field, eliminating the need to sterilize the sensor itself and simplifying the overall sterilization process.
2Reliability
If separate sterilization procedures are used for different components, then sterilization effectiveness is improved, but time consumption increases
Solution Approach 1:
Components are sterilized in advance using appropriate methods (gamma irradiation for flow components, autoclave for sensors) before assembly. The sterile barrier is pre-attached to adapters, and all sterilization activities are completed prior to final system assembly in the clean room, eliminating the need for time-consuming sterilization steps after assembly.
Solution Approach 2:
By segmenting the sterilization process into independent parallel tracks for different component types, the overall time is reduced compared to sequential sterilization approaches. Multiple components can be sterilized simultaneously using their respective optimal methods.
3Reliability
If sensors are sterilized using gamma irradiation, then sterilization effectiveness is improved, but sensor functionality deteriorates
Solution Approach 1:
A sterile barrier (membrane or sterile adapter) serves as an intermediary that physically separates the sensor from the sterile flow stream. This allows the sensor to remain outside the sterile field and be sterilized using autoclave or chemical methods that do not damage electronic components, while still maintaining sterile isolation through the barrier.
Solution Approach 2:
The sterile barrier is designed as a disposable component that is discarded after use, eliminating the need to repeatedly sterilize expensive sensors. The barrier maintains sterile isolation for each use, and sensors can be reused without exposure to harsh sterilization methods.
4Reliability
If a sterile environment is maintained during assembly, then sterility is improved, but cost increases
Solution Approach 1:
All sterilization activities are performed in advance during component manufacturing, and components are assembled in a clean room environment without requiring a full sterile barrier. The sterile adapters or membranes are pre-attached to components before assembly, reducing the complexity and cost of maintaining a sterile environment during assembly operations.
Solution Approach 2:
Sterile adapters or membranes serve as intermediaries that maintain sterile isolation at specific connection points without requiring the entire assembly environment to be sterile. This localized approach to sterility maintenance is more cost-effective than maintaining a completely sterile assembly environment.
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
This approach reduces the time and cost associated with sensor integration and maintains the sterility of the flow stream by preventing foreign bodies from passing through the membrane, while allowing necessary particles to reach invasive sensors.
Implementation Method 1
A sterile grade membrane is used to separate the sensor from the sterile flow stream... The membrane serves to separate the sterile environment within the flow stream from the sensor, thereby reducing the time needed to interface a sensor to a sterile flow path
Data Source
AI summary
A system and method for interfacing non-sterile sensors to a sterile flow stream is disclosed. Typically, sensors cannot be sterilized in the same manner as other components of the flow stream. This results in complex processes to incorporate a sterilized sensor into a sterilized flow stream. By introducing a separation membrane, the desired sensor can be interfaced to the sterile flow stream. By doing so, the sensor need not be sterile, only sufficiently clean. The membrane separates the sterile environment within the flow stream from the sensor, while still permitting the sensor to function.