PE Bottles for Autoclave Full Validation

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.


Dear Sir

Please provide the information for PP ampoules that where you are purchasing. We require PP ampoules urgently.

We will be highly appreciated for your early response.

Thanks for reply in advance.

Sarath Chandra
QA-Asst. Manager