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Last Modified: Tuesday, July 06, 2021

EtO Sterilization Validation

EtO sterilization is used on heat sensitive products.

Consequently, validation exercises must verify that temperature remains within specified parameters. Other critical parameters are pressure and humidity.

Because of the concerns about the chamber seals, remote battery powered loggers are generally preferred for EtO sterilization validation over thermocouple and transducers cabled to an exterior data acquisition device. Loggers such as TMI-Orion NanoVacq Ex are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation 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 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 validation 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 check 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 Sensor Usage and allows engineers to set limits.

There is a wide variation in the size of EtO chambers and the processes specified within the chamber. Because of this, validation engineers performing EtO sterilization validation should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.

TQSoft™ thermal validation 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.

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