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Max and Min Load Determination for Steam Sterilization of Liquds

htcoztrk

Starting to get Involved
#1
Hello all.

We're developping a new medical device and it requires to be sterilized by steam. Me or neither my company only have experience on EO and irridation sterilization.

Now we're preparing the protocol for validation and try to determine the load configuration. Iknow that minimum loads of liquids tend to heat faster than maximum load so we'll perform triplicate cycle for both load. I have one question about minimum and maximum load for sterilization liquid loads. Now we're going to sterilize items from 1ml to 5ml in syringe using steam sterilization. I'm really having troubles case how we should determine the min and max load.
a) Select 5ml (biggest size) as worst case (because slowest to heat) and configurate the smallest quantity as min load and biggest quantity for chamber as max load
b) Select 1ml as maximum and load the chamber with the biggest quantity and select 5ml as minimum load and load the chamber with biggest quantity of size. (But in this case do we have to use the biggest quantity for both size in routine processing?)
c) Select the smallest quantity of smallest size (1ml) as minimum and select the biggest quantity of biggest size (5ml) as maximum?
d) Select minimum and maximum load individually for each size. The smallest quantity as minimum and biggest quantity as minimum for the smallest size (1ml) and biggest size (5ml). Total there will be 2 min and 2 max load configuration?

Thank you in advance.
 
#2
Hi, I'm not an expert on steam sterilisation either, however, I would suggest looking through the various parts of ISO17665. In particular, Part 3 covers . "Guidance on the designation of a medical device to a product family and processing category for steam sterilization". This may give you the answer you are looking for.
 
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