Validation of Sterilization Process

My question regards “Mapping”. Is this the responsibility of the Equipment Manufacturer or user or both.
Unless there is a significant change/modification of Equipment, I don’t think locations marked, as slow to heat, are meant to change, hence must be a manufacturer’s responsibility. If the user has to perform exercise, what would be the steps outlined?

Dear Joseph,

Definitely mapping is also responsibility of the manufacturer, but who is going to use the equipment? Of course, you as user. So, it is user’s responsibility to verify the slow to heat locations (cold points / zones) in the Autoclave after installing at user’s site. For this you can use the study data of the manufacturer as basic idea.

Now, about 12 temperature probes can be used for an Autoclave of about 1m3 chamber size. Three runs can be taken and the location of the probes can be changed in every cycle.
For further details, please feel free to contact.



Owner’s responsibility. Thermal mapping is the basis for all further studies and requalification. I like to use more TCs…5 front, 5 middle, 5 back, 1 at control RTD, 1 at drain.


At the time of commissioning this is the manufacturer’s responsibility but after successfuly completed of commissioning that it is user responsibility.