Ethylene Oxide to Chlorine Dioxide Sterilizer Conversion Module
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Solution Overview
Problem
Existing ethylene oxide sterilizers pose environmental and health risks due to ethylene oxide's carcinogenic and explosive nature, prompting the need for alternative sterilization methods like chlorine dioxide gas, which can be implemented in existing chambers to reduce capital expenditures.
Innovation Solution
A module that converts existing ethylene oxide vacuum sterilizers into chlorine dioxide gas vacuum sterilizers, including components for producing chlorine dioxide gas, monitoring processes, documenting regulatory requirements, and integrating a Human Machine Interface (HMI) and Process Control System (PCS) to manage sterilization cycles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ethylene oxide sterilization is used, then sterilization capability is achieved, but health and environmental risks increase due to carcinogenicity and explosiveness
Solution Approach 1:
The patent changes the chemical composition parameter of the sterilization gas from ethylene oxide to chlorine dioxide, transforming the harmful properties while maintaining sterilization effectiveness. This parameter change eliminates carcinogenicity and explosiveness while preserving the ability to sterilize medical devices.
Solution Approach 2:
The patent converts the existing ethylene oxide sterilization system into a chlorine dioxide system by adding a gas generation module. This transforms the harmful ethylene oxide process into a beneficial chlorine dioxide process that maintains sterilization capability while eliminating health and environmental hazards.
2Object-affected harmful factors
If new chlorine dioxide sterilization chambers are installed, then sterilization safety is improved, but capital expenditures increase
Solution Approach 1:
The patent makes the existing ethylene oxide sterilization chamber multi-functional by adding a chlorine dioxide gas generation module. The same chamber can now accommodate both ethylene oxide and chlorine dioxide sterilization processes, eliminating the need for separate dedicated chambers and reducing capital expenditures.
Solution Approach 2:
The patent introduces a chlorine dioxide gas generation module as an intermediary component that connects to the existing ethylene oxide sterilization chamber. This module enables chlorine dioxide delivery without requiring complete replacement of the sterilization infrastructure, thereby reducing capital investment while improving safety.
3Object-affected harmful factors
If existing ethylene oxide sterilizers are converted to chlorine dioxide systems, then health risks are reduced, but device complexity increases
Solution Approach 1:
The patent segments the sterilization system into distinct functional modules: the existing sterilization chamber and the newly added chlorine dioxide gas generation module. This segmentation allows the conversion to be achieved by adding a separate, self-contained gas generation system rather than redesigning the entire sterilization infrastructure.
Solution Approach 2:
The patent uses a chlorine dioxide gas generation module as an intermediary device that interfaces with the existing ethylene oxide sterilization chamber. This intermediary module handles all chlorine dioxide generation and delivery functions, minimizing the complexity changes required in the existing system while achieving the health risk reduction goals.
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 the safe and efficient conversion of existing ethylene oxide sterilizers to chlorine dioxide systems, reducing health and environmental risks while minimizing the need for new equipment, thus offering a cost-effective and scalable solution for medical device sterilization.
Implementation Method 1
The module includes sample pumps and tubing that pull gas from the chamber and into the module's photometer
Implementation Method 2
The HMI and PCS also trigger the vacuum pump on the sterilizer to pull vacuum to achieve different pressure levels at selected times within the chamber
Implementation Method 3
The module generates the gas by sending 1-4% chlorine gas through CD Cartridges which generate 2-8% chlorine gas
Data Source
AI summary
This invention serves to repurpose existing ethylene oxide sterilization chambers utilizing a novel chemical means of sterilization. Ethylene oxide is a longstanding gaseous sterilant for medical devices but has increasing problems associated with its hazards. Ethylene oxide is a carcinogenic and explosive chemical, and its emissions can be very harmful and cause serious health risks. Due to this, the FDA and many medical device manufacturers are trying to reduce or eliminate the use of the gas. Chlorine dioxide gas is a nearly identical alternative mode of sterilization that is non-carcinogenic and non-explosive. If firms choose to eliminate the use of ethylene oxide but do not want to waste the capital expenditure on existing sterilizers, they can instead utilize the ethylene oxide-to-chlorine dioxide conversion system of the present invention and use an effective and environmentally friendly form of sterilization in a system they already possess.

