Hello forum readers
I realise that there is a fairly large amount of autoclave qualification/validation information in this extremely helpful forum, but i dont think my question has yet been answered.
I am looking to carry out an annual qualification on an a number of autoclaves, which have already had the IQ/OQ and PQ testing carried out. Im looking for ‘guidance’ on a few points.
Firstly, do i need to carry out empty, min load and max load testing?
Secondly, is Bacterial Indicator testing necessary (or can i argue that the USP has stated that 121degC is sufficient, so if i reach that for the set time, then that is enough). If i do need to BI test, do i just need to run the test with my full load, or each time?
Thirdly, i am looking to run with between 10-15 wireless temperature probes, one in each corner, one in the middle and one as close to the drain as product would be. Is this enough (discounting probes insde bottles etc.)?
And finally, is one pressure probe in the centre of the autoclave sufficient - the laws of pressure in a loaded/heated chamber are a bit beyond me.
Thank you so much for taking the time to read this and i hope someone can offer some advice.