Pharmaceuticals/BFS products


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
Many thanks

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.

---------- FOLLOW-UP ----------

QUESTION: Many Thanks for prompt response
For low temperature BI , ,
the cycle passed with SterilAmp II 5230 ,
would this be satisfactory for Authorization Audit , or will we need to use BI @121

Many thanks

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.


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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