QUESTION: Dear Dr Anisfeld
Many thanks for efforts
my question is regarding BFS products in PE containers
as we use low temperature sterilization cycle , 108 for 45 minutes which achieve F0 less than 3 , Validation with normal BI fail , we used low temperature BI which passed on 60 minutes at 110 ,
the problem is of high reject in filled bottles due to temperature
Can we go back to 45 minutes at 108 and consider it as Heat treatment , and validate the process by Aseptic process validation
ANSWER: Dear Misa:
As you have to demonstrate a minimum of Fo = 8, I am not sure that you will have success in registering the product. with an Fo of <3. For this study you need to use pharmacopoeial recognized BI (e.g. B. stearothermophilus) - I have never heard of a 'low temperature BI'.
I used to manufacture LVPs made using BFS technology, and by changing the PE source and playing with the cycle parameters, we were able to achieve an Fo of 5. With a lot of effort we managed to persuade the FDA of an acceptable cycle associated with an aseptic fill regimen.
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QUESTION: Many Thanks for prompt response
For low temperature BI , http://biologicalindicators.mesalabs.com/sterilamp/
the cycle passed with SterilAmp II “5230” ,
would this be satisfactory for Authorization Audit , or will we need to use BI @121
Your chances of passing an FDA (or EMA or other highly regulated country) inspection with the data you have is very close to zero. Sorry.
As I have made BFS PE containers and have been able to attain an Fo of 6 (and had a very difficult time gaining FDA approval, until we also incorporated a sterile fill environment), I do not understand why you cannot do the same.