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 the criteria called Heat distribution/uniformity
It is a measure of how evenly the temperature is distributed throughout the sterilisation chamber and/or the load.
An uneven distribution of temperature is a sign that the sterilizer is not capable of processing the load and will need further investigation.
There are several ways this can be analysed for example.
checks the delta (max-min) for every sample point during exposure and returns the maximum value. This method is useful because it disregards the variation often seen during the early part of the exposure period while the temperature is stabilising.
This is a mathematical representation of the amount of deviation there is across all sensors from the mean. The problem with this is the value is a relative number for example 1 deviation is low whereas 3 deviations is high so it’s a bit more subjective.
Many other calculations are also possible within XpertLog software which can indicate the absolute deviation from the mean such as.
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
