Process challenge device and methods

A method of controlling the level of resistance to a sterilization process provided by a process challenge device, the method comprising:

• providing a process challenge device comprising:
• a container defining a space within the container, wherein the space can fully contain a process indicator;
• and
• at least one pressure-actuating valve associated with the container, wherein
• the at least one pressure-actuating valve regulates entrance of a sterilant into and exiting of a gas and/or liquid out of the space within the container;
• wherein the process challenge device further comprises a feature for controlling the level of resistance, the feature selected from the group consisting of:
• at least one pressure-actuated valve can be adjusted to increase or decrease the pressure difference required to actuate the valve;
• the space further contains a volume of gas, wherein the volume can be adjusted to a volume of at least 5 cubic centimeters and not more than 1000 cubic centimeters.
• the device further comprises a heat-transfer modulating body, wherein at least a portion of the body at least surrounds the process indicator when present, the at least a portion of the heat-transfer modulating body comprises walls which at least surround the indicator when present;
• and
• a combination thereof;
• adjusting the sterilization process challenge device to provide a targeted level of resistance to a sterilization process;
• wherein adjusting comprises a step selected from the group consisting of:
• adjusting the at least one pressure-actuated valve;
• adjusting the volume of the gas,
• adjusting the thickness of the heat-transfer modulating body walls;
• adjusting a thermal diffusivity of the heat-transfer modulating body;
• and
• a combination thereof.