The new revision of Annex 1 now specifies the test criteria that shall be used for Thermal Validation of sterilisation by heat cycles.
In this article we look at one such criteria called equilibration time
Equilibration time refers to the time required for the entire load to reach the necessary temperature. Annex 1 states ”Sufficient time should be allowed for the whole of the load to reach the required temperature before measurement of the sterilizing time-period starts” and it goes on to say that “Validation of porous cycles should include a calculation of equilibration time”
It’s a great indication of the autoclaves effectiveness to remove air (non-condensable gases) from the load items and replace them with steam. A long equilibration time of over 15 or 30 seconds depending on the size of the autoclave is a sign of a problem for example with the Autoclave, the load or the loading pattern.
This is a simple calculation of elapsed time from the start moment until the moment when all the temperature sensors in the load have reached temperature. The start moment will be either when the chamber temperature or the temperature at the reference point (usually the Drain sensor) reaches the minimum required temperature. The ideal is a zero second equilibration time, but acceptable limits are typically 15 or 30 seconds depending on the size of the steriliser.
To learn more about how XpertLog software ensures your compliance by integrating all necessary acceptance criteria stipulated by the new Annex 1, simply click the link below.
https://lp.constantcontactpages.com/sl/q7Dp4vp/annex1series
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