Self-contained sterilant monitoring assembly and method of using same

Abstract

A system for monitoring concentrations of sterilant, such as hydrogen peroxide vapor, within a sterilization apparatus, includes a self-contained, sterilant monitoring assembly that is freely positionable within the sterilization apparatus. The assembly includes a gas-detecting sensor and associated temperature sensor mounted on a portable structure, as well as a suitable data collection circuit for receiving output signals from the sensors. The assembly also includes signals connectors, such as a physical data port or a remote transmitter, or both. Signals can be transmitted concurrently with data collection, or an electronic memory may be provided for subsequent transfer of the collected data. Collected data is transferred to a remote communication unit positioned exteriorly of the sterilization apparatus. The collected data is processed by a processor, which is either provided as part of the monitoring assembly or provided remotely as part of the monitoring system as a whole, to identify the corresponding detected sterilant levels. The assembly is operated by a power source, which can be activated manually, by preprogrammed relays, or remotely by a control system capable of receiving control signals via near infrared or radio wave transmissions. A carrier element is provided to carry the sterilant monitoring assembly along the conveyor path of the sterilization apparatus and, thus, collect data at each sterilization station.

What is claimed is:  
     
         1 . A sterilant monitoring assembly for a sterilization apparatus using a sterilant, the sterilant monitoring assembly comprising: 
 a sterilant sensor configured to provide output signals corresponding to detected levels of the sterilant;    a data collection circuit operatively coupled to said sterilant sensor to receive the output signals from said sterilant sensor as collected data; and    a power source to provide electrical power to said sterilant sensor and said data collection circuit;    wherein the sterilant sensor, the data collection circuit and the power source are self-contained on a portable structure so as to be freely positionable proximate the sterilization apparatus to monitor levels of the sterilant thereat.    
     
     
         2 . A sterilant monitoring assembly in accordance with  claim 1 , wherein the data collection circuit includes an electronic memory to create a readable memory of the data collected during a selected time interval, and a signal connector to allow transfer of signals representative of the collected data from said electronic memory to a remote communication unit in communication with the signal connector.  
     
     
         3 . A sterilant monitoring assembly in accordance with  claim 1 , wherein the data collection circuit includes a transmitter to transmit signals representative of the collected data to a remote communication unit.  
     
     
         4 . A sterilant monitoring assembly in accordance with  claim 1 , further including a temperature sensor operatively coupled to the data collection circuit to provide output signals corresponding to the ambient temperature proximate the sterilant sensor for collection in combination with the output signals from said sterilant sensor.  
     
     
         5 . A sterilant monitoring assembly in accordance with  claim 1 , wherein: 
 said sterilant sensor includes a gas-detecting semiconductor element and a heater to elevate the temperature of the gas-detecting semiconductor element.    
     
     
         6 . A sterilant monitoring assembly in accordance with  claim 1 , further comprising a control system provided on the portable system and in communication with the power source to allow the power source to be activated remotely.  
     
     
         7 . A sterilant monitoring assembly in accordance with  claim 1 , wherein 
 said sterilant is hydrogen peroxide (H 2 O 2 ) vapor, said sterilant sensor providing output signals corresponding to detected levels of H 2 O 2  vapor.    
     
     
         8 . A sterilant monitoring assembly in accordance with  claim 1 , further including: 
 a carrier element configured as an article to be sterilized by the sterilization apparatus, said portable structure being positionable on said carrier element during sterilization by the sterilization apparatus to monitor a sterilization cycle to which articles are subjected.    
     
     
         9 . A hydrogen peroxide (H 2 O 2 ) vapor monitoring assembly for a sterilization apparatus using H 2 O 2  vapor to sterile articles, the H 2 O 2  vapor monitoring system comprising: 
 an H 2 O 2  vapor sensor configured to provide output signals corresponding to detected levels of H 2 O 2  vapor, said H 2 O 2  vapor sensor including a gas-detecting semiconductor element and a heater to elevate the temperature of said gas-detecting semiconductor element;    a temperature sensor configured to provide output signals corresponding to the ambient temperature proximate said H 2 O 2  vapor sensor;    a data collection circuit operatively coupled to said H 2 O 2  vapor sensor and said temperature sensor to receive output signals therefrom as collected data; and    a power source to provide electrical power to said H 2 O 2  vapor sensor, said temperature sensor and said data collection circuit;    wherein the H 2 O 2  vapor sensor, the temperature sensor, the data collection circuit and the power source are self-contained on a portable structure so as to be freely positionable proximate a sterilization apparatus to monitor levels of the H 2 O 2  vapor thereat.    
     
     
         10 . An H 2 O 2  vapor monitoring assembly in accordance with  claim 9 , wherein the data collection circuit includes an electronic memory to create a readable memory of the data collected during a selected time interval and 
 a signal connector to allow transfer of signals representative of the collected data from said electronic memory to a remote communication unit in communication with the signal connector.    
     
     
         11 . An H 2 O 2  vapor monitoring assembly in accordance with  claim 9 , wherein the data collection circuit is configured to perform data collection in accordance with selected conditions, the data collection circuit including a signal connector to allow entry of selected conditions for such data collection.  
     
     
         12 . An H 2 O 2  vapor monitoring assembly in accordance with  claim 9 , wherein the data collection circuit includes a transmitter to transmit signals representative of the collected data to a remote communication unit.  
     
     
         13 . A method of monitoring levels of sterilant within a sterilization apparatus, the method comprising the steps of: 
 providing a self-contained sterilant monitoring assembly including: 
 a sterilant sensor configured to provide an output signal corresponding to detected levels of the sterilant,  
 a data collection circuit operatively coupled to said sterilant sensor to receive the output signal from said sterilant sensor as collected data, and  
 a power source to provide electrical power to said sterilant sensor and said data collection circuit, wherein the sterilant sensor, the data collection circuit and the power source are self-contained on a portable structure; and  
 positioning said sterilant monitoring assembly proximate said sterilization apparatus to collect data representative of sterilant levels thereat; and  
 transferring the collected data from the data collection circuit to a processor to identify the sterilant levels detected by the sterilant sensor.  
   
     
     
         14 . A method of monitoring sterilant in accordance with  claim 13 , wherein: 
 the data collection circuit of the sterilant monitoring assembly provided by the providing step further includes an electronic memory to create a readable memory of the data collected during a selected time interval, and a signal connector to allow transfer of signals, which are representative of the collected data, from the electronic memory to a remote communication unit in communication with the signal connector; and    the method further including the step of removing said sterilant monitoring assembly from said sterilization apparatus after said selected time interval, the transferring step including transferring the collected data to the processor as signals transferred through the signal connector from said electronic memory to the remote communication unit after the sterilant monitoring assembly has been removed from the sterilization apparatus.    
     
     
         15 . A method of monitoring sterilant in accordance with  claim 14 , wherein the data collection circuit is configured to perform data collection in accordance with selected conditions, the data collection circuit including a signal connector to allow entry of selected conditions for such data collection; the method further including the step of entering selected conditions for such data collection.  
     
     
         16 . A method of monitoring sterilant in accordance with  claim 13 , wherein: 
 the sterilant monitoring assembly provided by the providing step further includes a temperature sensor operatively coupled to the data collection circuit to provide output signals corresponding to the ambient temperature proximate the sterilant sensor for collection in combination with the output signals from said sterilant sensor; and wherein the transferring step further includes transferring collected data from the data collection circuit representative of the detected ambient temperature to the processor.    
     
     
         17 . A method of monitoring sterilant in accordance with  claim 13 , wherein: 
 the data collection circuit of the sterilant monitoring assembly provided by the providing step further includes a transmitter to transmit signals representative of the collected data to a remote communication unit in communication with the processor; and    further wherein the transferring step includes transmitting collected data from the data collection circuit to the processor as signals transmitted through the transmitter.    
     
     
         18 . A method of monitoring sterilant in accordance with  claim 13 , wherein 
 said sterilization apparatus sterilizes articles moved along a conveyor path, said positioning step including moving said sterilant monitoring assembly along said conveyor path of said sterilization apparatus.    
     
     
         19 . A method of monitoring sterilant in accordance with  claim 18 , wherein: 
 the positioning step includes providing a carrier element configured as an article to be sterilized by the sterilization apparatus, said portable structure being placed on said carrier element; and    loading the carrier element on the conveyor path as an article to be sterilized by the sterilization apparatus.    
     
     
         20 . A method of monitoring sterilant in accordance with  claim 13 , wherein: 
 said sterilant includes hydrogen peroxide (H 2 O 2 ) vapor, said sterilant sensor providing output signals corresponding to detected levels of the H 2 O 2  vapor.