Autoclave Loading pattern

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
#1

Dear Forum members

After validating the minimum & maximum autoclave loading patterns, is it acceptable to do the in between loads,
For example
Minimum validated loading pattern is 05 bags (1000 plugs/bag) &
Maximum validated loading pattern is 45 bags (1000 plugs/bag)

During the routine, can we do the autoclave with 35 bags (1000 plugs/bag)?
if not what is the remedy.

What is the regulatory requirment

Thanks & regards
Pramoth.

#2

You can do with 35 bags (1000 plugs/bag).
As per regulatory point of view you are not exceeding the higher validated limit.
It falls with in your Highest and lowest validated loading patterns.
Its perfectly alright as in your case.

#3

That’s the reason you do minimum and maximum loads. So yes, you can do 35 bags.

#4

Yes you can always do this. Only care to be taken is the loading pattern of these 35 bags should be same as like the 45 bags.