Temperature distribution is the thorough documentation of the process delivery system as it is installed and operated in any given facility. This documentation includes, but is not limited to, surveys of the utility piping to the retort(s), boiler type and capacity, air compressor type and capacity, water pressure and quality, type of control system, temperature profile, and temperature uniformity/stability within the vessel as well as operational and performance repeatability.
The measurement of the temperature exposure is generally accomplished by installing thermocouples throughout the retort load, and testing the sterilizer under the most adverse conditions anticipated during normal production. Once the vessel's temperature distribution has been determined to be acceptable, any alterations to the process delivery system as documented at the time of testing should be reviewed by a competent process authority before the alterations are made. Additionally, any changes to the operation of the retort (i.e., change in the vent schedule or required come-up time) must be reviewed prior to adoption.
CALSoft is a tool used to conduct these Temperature Distribution tests. The resulting CALSoft "Temperature Distribution Data File" contains the recorded time/temperature data from the test, in addition to pertinent information such as retort information, lead location diagram, temperature setpoints, etc.