Systems and methods to evaluate inactivation kinetics of a biological indicator

A computer-readable medium storing computer-readable instructions that, when executed by a processor, cause the processor to evaluate inactivation kinetics of a biological indicator using data from studies that utilized a resistometer, wherein the resistometer is configured to implement a gaseous sterilization process, the computer-readable medium comprising:

• a first set of biological indicator data receiving module that, when executed by a processor, causes the processor to receive a first set of biological indicator data obtained from test samples processed under at least one first sterilant gas injection phase, wherein the first set of biological indicator data is representative of viable spore counts of the biological indicator;
• an enumeration-D values data generation module that, when executed by a processor, causes the processor to generate D values from enumeration viable spores counts data, implementing an enumeration method for determining viable spore counts, based on the first biological indicator data;
• a second set of biological indicator data receiving module that, when executed by a processor, causes the processor to receive a second set of biological indicator data during at least one second sterilant gas injection phase, wherein the second biological indicator data is representative of viable spore counts of the biological indicator;
• a fraction-negative-D values data generation module that, when executed by a processor, causes the processor to generate fraction-negative-D values, implementing a fraction negative method for determining viable spore counts, based on the second set of biological indicator data;
• and
• an inactivation profile data generation module that, when executed by a processor, causes the processor to establish an inactivation profile of the biological indicator based on the enumeration-D values data and the fraction-negative-D values data.

A system to evaluate inactivation kinetics of a biological indicator using a resistometer that is configured to implement a gaseous sterilization process, the system comprising:

• a time clock;
• a resistometer chamber pressure sensor;
• a resistometer chamber temperature sensor;
• at least one resistometer chamber sterilant concentration level sensor;
• a first set of biological indicator data receiving module stored on a memory that, when executed by a processor, causes the processor to receive a first set of biological indicator data during at least one first sterilant gas injection phase, wherein the first biological indicator data is representative of viable spore counts of the biological indicator;
• an enumeration-D values data generation module stored on a memory that, when executed by a processor, causes the processor to generate enumeration-D values data, implementing an enumeration method for determining viable spore counts, based on the first biological indicator data;
• a second set of biological indicator data receiving module stored on a memory that, when executed by a processor, causes the processor to receive a second set of biological indicator data during at least one second sterilant gas injection phase, wherein the second biological indicator data is representative of viable spore counts of the biological indicator;
• a fraction-negative-D values data generation module stored on a memory that, when executed by a processor, causes the processor to generate fraction-negative-D values, implementing an fraction negative method for determining viable spore counts, based on the second set of biological indicator data;
• and
• an inactivation profile data generation module stored on a memory that, when executed by a processor, causes the processor to establish an inactivation profile of the biological indicator based on the enumeration-D values and the fraction-negative-D values.