Dear all,
I would like to ask your opinion on the following topic:
We are manufacturing sterile solutions in PE bottles and PP ampoules, which are terminally sterilized. While PP ampoules can sustain a temperature of 121.1 degrees Celcius, the PE bottles cannot. This is the reason why the criterion set for the terminal sterilization of PP ampoules is at least 121.1 deg C for 15 min, whereas for the PP ampoules the criterion set is 111 deg C for at least 10 min.
This have been proved through autoclave validation that provides us with the accepted Fo and that it is achieved a 10^6 population reduction in the bacterial endotoxin original concentration.
What I would like to ask is if there is any FDA guideline with respect to the above topic.
Thank you very much all.
Cooly