Method

In addition to achieving minimum and maximum temperatures for set time periods, there are a number of other measurements, which many users find critical. These include the equilibration time, which is the difference between the first sensor achieving temperature and the last. Also, the spread of temperatures during the sterilization period and the deviation of individual temperature sensors over the sterilization period are also considered critical during the validation of autoclaves.

Another critical parameter is the use of saturated steam. In order for the sterilization to be effective the steam has to be saturated, as this transfers the most energy from the steam to the product. To facilitate the validation of this parameter ValSuite™ Pro software includes a saturated steam analysis that correlates temperature and pressure automatically.

To document the validation adequately a diagram must be made that shows all the sensor’s ID numbers related to their exact position in the autoclave. This is easily done in ValSuite™ Pro software by integrating the data session with predefined schematics, pictures and Word documents.

A critical factor when validating autoclaves is the calibration of temperature sensors. It is essential that the user can demonstrate that the sensors were within an acceptable accuracy when they were used. This means calibrating shortly before the validation run (referred to as Pre Calibration) and then checking the accuracy afterwards to ensure that they are still within predefined tolerances (referred to as Post Calibration). Using the automatic calibration feature in ValSuite™ Pro software simplifies the procedure and the software generates a complete calibration report.

Ellab Validation Solutions
Both the E-Val Flex thermocouple system and the TrackSense® Pro wireless data loggers are well suited to the validation of autoclaves. To validate the sterilization process according to the predefined acceptance criteria ValSuite™ Pro software is a valuable tool.