System for converting an existing ethylene oxide vacuum sterilizer into a chlorine dioxide vacuum sterilizer
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.
1. A system for converting an existing ethylene oxide vacuum sterilizer into a chlorine dioxide vacuum sterilizer, the system comprising:
an ethylene oxide vacuum sterilization chamber, having a chamber interior, wherein the ethylene oxide vacuum sterilization chamber is a component of the existing ethylene oxide vacuum sterilizer;
a chlorine dioxide generator, which pneumatically communicates with the chamber interior, wherein the chlorine dioxide generator comprises a source of a chlorine gas and at least one cartridge that is configured to chemically convert the chlorine gas into a chlorine dioxide gas and to inject the chlorine dioxide gas into the chamber interior at a controlled rate corresponding to a selected chlorine dioxide concentration in the chamber interior;
a vacuum pump, which pneumatically communicates with the chamber interior, wherein the vacuum pump is configured to create and control a partial vacuum of a selected sterilization pressure within the chamber interior, and wherein the vacuum pump is configured to effect a controlled post-sterilization evacuation of the chamber interior and to pump an evacuated gas out of the chamber interior;
a steam generator, which pneumatically communicates with the chamber interior through a steam injection port, wherein the steam generator is configured to inject a controlled flow of steam into the chamber interior, as determined by a selected sterilization relative humidity within the chamber interior;
a process control system, comprising multiple sensors configured to monitor multiple process conditions within the chamber interior, wherein the process conditions comprise chlorine dioxide concentration, vacuum pressure, relative humidity, and temperature, and wherein, based on readings of the process conditions by the sensors, the process control system is configured to control the chlorine dioxide generator, the vacuum pump and the steam generator to produce and maintain within the chamber the selected chlorine dioxide concentration, the selected sterilization pressure, the selected sterilization relative humidity, and a selected sterilization temperature, for a selected sterilization duration based on a measured or estimated accumulated chlorine dioxide dosage, and wherein, at the conclusion of the selected sterilization duration, the process control system is configured to control the vacuum pump to evacuate the chamber interior; and
a human-machine interface, which is configured to receive user inputs that specify multiple sterilization process parameters, comprising the selected chlorine dioxide concentration, the selected sterilization pressure, the selected sterilization relative humidity, the selected sterilization temperature, and the selected sterilization duration based on the measured or estimated accumulated chlorine dioxide dosage, wherein the human-machine interface is configured to transmit the sterilization process parameters to the process control system.
2. The system according to claim 1 , further comprising a scrubber, which pneumatically communicates with the vacuum pump, wherein, at the conclusion of the selected sterilization duration, the process control system is configured to control the vacuum pump to evacuate the chamber interior into the scrubber, and to control the scrubber to remove a post-sterilization residual chlorine dioxide gas from the evacuated gas and to exhaust a scrubbed airflow into an ambient atmosphere.
3. The system according to claim 1 , wherein the vacuum pump or the steam generator, or both the vacuum pump and the steam generator, are components of the existing ethylene oxide vacuum sterilizer.
4. The system according to claim 2 , wherein the vacuum pump or the steam generator, or both the vacuum pump and the steam generator, are components of the existing ethylene oxide vacuum sterilizer.
5. The system according to claim 2 , wherein the scrubber utilizes activated carbon to remove the post-sterilization residual chlorine dioxide gas from the evacuated gas.
6. The system according to claim 4 , wherein the scrubber utilizes activated carbon to remove the post-sterilization residual chlorine dioxide gas from the evacuated gas.
7. The system according to claim 1 , wherein the sterilization process parameters are determined based on characteristics of a medical device to be sterilized selected from the group consisting of: composition of the medical device, including device packaging if any, gas permeability of the medical device, including device packaging if any, types of bacterial endotoxins present in the medical device, a concentration of bacterial endotoxins present in the medical device, a bioburden of the medical device, and a sterilization resistance valve determined by an External Process Challenge Device.
8. The system according to claim 2 , wherein the sterilization process parameters are determined based on characteristics of a medical device to be sterilized selected from the group consisting of: composition of the medical device, including device packaging if any, gas permeability of the medical device, including device packaging if any, types of bacterial endotoxins present in the medical device, a concentration of bacterial endotoxins present in the medical device, a bioburden of the medical device, and a sterilization resistance valve determined by an External Process Challenge Device.
9. The system according to claim 3 , wherein the sterilization process parameters are determined based on characteristics of a medical device to be sterilized selected from the group consisting of: composition of the medical device, including device packaging if any, gas permeability of the medical device, including device packaging if any, types of bacterial endotoxins present in the medical device, a concentration of bacterial endotoxins present in the medical device, a bioburden of the medical device, and a sterilization resistance valve determined by an External Process Challenge Device.
10. The system according to claim 4 , wherein the sterilization process parameters are determined based on characteristics of a medical device to be sterilized selected from the group consisting of: composition of the medical device, including device packaging if any, gas permeability of the medical device, including device packaging if any, types of bacterial endotoxins present in the medical device, a concentration of bacterial endotoxins present in the medical device, a bioburden of the medical device, and a sterilization resistance valve determined by an External Process Challenge Device.
11. The system according to claim 5 , wherein the sterilization process parameters are determined based on characteristics of a medical device to be sterilized selected from the group consisting of: composition of the medical device, including device packaging if any, gas permeability of the medical device, including device packaging if any, types of bacterial endotoxins present in the medical device, a concentration of bacterial endotoxins present in the medical device, a bioburden of the medical device, and a sterilization resistance valve determined by an External Process Challenge Device.
12. The system according to claim 6 , wherein the sterilization process parameters are determined based on characteristics of a medical device to be sterilized selected from the group consisting of: composition of the medical device, including device packaging if any, gas permeability of the medical device, including device packaging if any, types of bacterial endotoxins present in the medical device, a concentration of bacterial endotoxins present in the medical device, a bioburden of the medical device, and a sterilization resistance valve determined by an External Process Challenge Device.