Integrated Process Challenge Device for Monitoring of Sterilization Processes

A method for determining efficacy of a sterilization process, the method comprising:

• providing an integrated process challenge device, the integrated process challenge device having a first indicator within a first compartment and a second indicator within a second compartment of the integrated process challenge device, the first compartment and the second compartment defined by the interior and exterior of the shell of the integrated process challenge device;
• placing the integrated process challenge device at a location within a sterilization system configured to regulate the sterilization conditions within the sterilization system;
• operating the sterilization system, wherein the integrated process challenge device has a first opening and a second opening defined on the shell, wherein the first and second openings allow a sterilant to enter and exit the first and second compartments;
• inserting the integrated process challenge device within a digital autoreader, the digital autoreader comprising at least one sensor to read one of the first indicator the second indicator;
• and
• operating the digital autoreader to assess whether the integrated process challenge device has been adequately sterilized by the sterilization system based on a reading from the at least one sensor.

A method for determining efficacy of a sterilization process, the method comprising:

• placing a biological indicator comprising a biological culture sample and a growth medium within a compartment of an integrated process challenge device, the compartment defined by an interior and an exterior of a shell of the integrated process challenge device;
• closing the integrated process challenge device thereby sealing the biological indicator within;
• placing the integrated process challenge device at a location within a sterilization system configured to regulate the sterilization conditions within the sterilization system;
• operating the sterilization system, wherein the integrated process challenge device has an opening defined on the shell, wherein the opening allows a sterilant may enter and exit the compartment;
• inserting the integrated process challenge device within a digital autoreader, the digital autoreader comprising a sensor to read an output of the biological indicator;
• activating the biological indicator without opening the integrated process challenge device;
• and
• operating the digital autoreader to assess whether the integrated process challenge device has been adequately sterilized by the sterilization system.

A method for determining efficacy of a sterilization process, the method comprising:

• placing a chemical indicator comprising at least one of a Type 5 or a Type 6 chemical indicator within a compartment of an integrated process challenge device, the compartment defined by an interior and an exterior of a shell of the integrated process challenge device;
• closing the integrated process challenge device thereby sealing the chemical indicator within;
• placing the integrated process challenge device at a location within a sterilization system configured to regulate the sterilization conditions within the sterilization system;
• operating the sterilization system, wherein the integrated process challenge device has an opening defined on the shell, wherein the opening allows a sterilant may enter and exit the compartment such that the chemical indicator is activated without opening the integrated process challenge device;
• inserting the integrated process challenge device within a digital autoreader, the digital autoreader comprising a sensor to read an output of the chemical indicator through the shell of the integrated process challenge device;
• and
• operating the digital autoreader to assess whether the integrated process challenge device has been adequately sterilized by the sterilization system.