Thermal Validation Systems
Problems with sterilization and process can occur with the spread of temperatures.
It is essential to identify the coolest and hottest part of the load or area and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its Interval Calculations feature.
The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensible to normal acceptable validation practice, no matter what sensors are used (RTDs, thermistors or thermocouples). The validation 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 thermal validation study. RTDs and thermistors require less frequent checking, usually periodically, every 6 months.
Generally speaking thermocouple accuracy is required to be +/- 0.5°C. For Dry Heat Sterilization (or Hot Air Sterilization or Depyrogenation 200°C to 400°C) accuracy is generally required to be +/- 1.0°C.
TQSoft™ thermal validation system software can help achieve these accuracies by providing simple to operate automated calibration and calibration check procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a TQSoft™ thermal 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 thermal validation process. TQSoft™ thermal validation system software tracks Sensor Usage and allows engineers to set limits.
Because of the variety and variation of processes run within sterilization and disinfection chambers, validation engineers should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. This is periodic revalidation. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.
TQSoft™ Interval Calculation feature can be used to track critical parameters, such as A(0), F(0), Mean Kinetic Temperature, and immediately highlight any test data that is not within specification.
TQSoft™ thermal validation system software provides a Reporting and Report Management module which can provide a large degree of automation to report production, and allow reports to be built, managed, converted to PDF, emailed and archived.
TQSoft™ thermal validation system software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and Audit Trail Management and has been developed and maintained according to GAMP. Tamperproof File Security is implemented.