Sensor Component Sterilisation via Sealed Cavity and Gaseous Agent
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Solution Overview
Problem
Existing methods for sterilizing sensor components used in analyte concentration measurement systems face challenges in maintaining the components in a sterile, hydrated state without causing damage from ionizing radiation or gaseous sterilizing agents.
Innovation Solution
A method involving a sealed cavity with ports, where a gaseous sterilizing agent is introduced and then replaced with a sterile liquid, ensuring the sensing elements remain hydrated and sterile until use, while allowing for the use of more benign sterilizing agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma irradiation is used to sterilize the sensor component in a wet condition, then the sensor component can be supplied in a sterile, hydrated state, but ionising radiation generates highly reactive free radicals and reactive oxygen species which cause drift in the optical properties and loss of signal
Solution Approach 1:
The sterilization process is divided into two distinct stages: first sterilizing the sensor component in a dry state using gamma irradiation, then rehydrating it with sterile water. This segmentation allows the use of aggressive sterilization methods without compromising the sensing elements, as the harmful radiation exposure occurs before hydration rather than concurrently with the sensing elements in a wet state.
Solution Approach 2:
The sensor component is sterilized in advance while in a dry state, before being rehydrated. This preliminary sterilization action allows the use of gamma irradiation without the risk of generating reactive species that would damage the sensing elements, since the component is not yet hydrated when exposed to radiation.
2Object-affected harmful factors
If gaseous sterilising agent is used, then damage to the sensor component is reduced, but the agent must be carried out dry to prevent interaction with the fluid, which creates chemicals damaging to sensing elements
Solution Approach 1:
The sensor component is sterilized in advance while in a dry state using gaseous sterilizing agents, before being rehydrated with sterile water. This preliminary sterilization allows the use of benign gaseous agents without risk of chemical interaction with fluids, as the component remains dry during the sterilization process.
Solution Approach 2:
The process is segmented into dry sterilization followed by rehydration. This separation allows the use of gaseous sterilizing agents in the dry state without their interacting with and damaging the sensing elements, while still achieving sterilization before the component is put into service.
3Reliability
If the sensor component is supplied with sensing elements in a non-hydrated state, then sterilisation can be performed, but it can take several hours for the optical properties to stabilize following exposure to the fluid
Solution Approach 1:
The sensing elements are pre-hydrated with sterile water before the sensor component is supplied to the user. This preliminary hydration action ensures that the optical properties stabilize before use, eliminating the several-hour stabilization period that would otherwise be required after initial fluid exposure.
Solution Approach 2:
The process is divided into sterilization, rehydration, and stabilization stages. By separating these steps and performing rehydration as a controlled preliminary action using sterile water, the component can be sterilized effectively while the rehydration and stabilization occur in a controlled manner before the component is put into 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
This method effectively sterilizes sensor components while maintaining their hydration state, reducing the risk of contamination and damage, and improving the accuracy of subsequent measurements.
Implementation Method 1
Sterilisation with a gaseous sterilising agent, such as ethylene oxide, is a much more benign method of sterilisation
Implementation Method 2
the sensing elements and other materials used in this type of sensor component become hydrated in use when exposed to the fluid
Implementation Method 3
In order to measure the concentrations of analytes in the fluid, it is necessary for parts of the sensor component to come into contact with the fluid
Data Source
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AI summary
A sensor component is sterilised for use in a system for measuring the concentration of one or more analytes in fluid in a fluid line. The sensor component comprises one or more sensing elements having an optical property that varies with the concentration of the one or more analytes in the fluid, and is configured to engage with the fluid line such that the sensing elements are exposed to the fluid. The method comprises introducing a gaseous sterilising agent into a sealed cavity via one or more ports providing fluid connection to the cavity, wherein the one or more sensing elements are exposed to the cavity, replacing the gaseous sterilising agent with a sterile liquid via the ports, and sealing the ports. Also disclosed is a sensor component with a configuration facilitating the application of the method.