Steam and validating

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Larger autoclaves can be used for sterilizing high volume parenterals such as those found in pouches.Bottles and ampoules are typically sterilized in smaller autoclaves.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 built-in calibration functionality, users can calibrate the Ellab sensors at regular intervals.The Val Suite™ Pro software generates an easy to read calibration report that includes all measurements and tolerances that are defined by the user.It is recommended that Ellab sensors and probes are sent in at least once a year for factory calibration (which includes a traceable calibration certificate).

For this reason, Ellab offers a wide range of fixtures and fittings.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 sterilization temperature and the last.To document the validation adequately a diagram must be made that shows all the sensors´ ID numbers related to their exact position in the autoclave.This is easily done in Val Suite™ Pro by integrating the data session with predefined schematics, pictures and Word documents.

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