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 exposure time.
Exposure time refers to the duration during which the entire load is maintained within the sterilization temperature range. It starts once the equilibration time has concluded, signifying that all sensors in the load have reached the required temperature for the sterilization cycle to begin.
Time and temperature are the fundamental physical parameters for a heat sterilisation cycle, for example a common moist heat sterilisation cycle for a porous load is 121°C for 15 minutes. In this case 15 minutes is the exposure time and represents the minimum time at which the whole load must remain at or above 121°C to deliver a successful sterilisation.
This is a calculation of elapsed time from the start moment when all the temperature sensors in the load first reach temperature until the final moment before the first senor drops out of temperature. The start moment is therefore the same as the end moment for equilibration time, but the end moment for exposure is defined in two logical steps, first record the time stamp when the first sensor drops out of range and then go back one measurement interval. The calculation of exposure time can be performed automatically by XpertLog software.
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
