Last Modified: Thursday, September 19, 2019

Sterilizer Temperature Distribution

Thermal distribution studies are essential throughout the food, pharmaceutical,
biotech and other industries, where temperature is a critical parameter in the processing.

Temperature distribution studies involve accurately measuring the temperature at various locations throughout an empty and a fully loaded process area. The area is required to maintain all parts of its load at specified temperature band for a specified period. Thus the objective of the distribution study is to identify the coldest and hottest part of the area and load. Studies must be performed for each load configuration and product configuration. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

The accuracy of the sensors and data acquisition hardware used to perform temperature distribution studies is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

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