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Pharmaceuticals/LVP aseptic filling

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Dear Dr

Many thanks for your efforts
our facility will produce Large volume parenterals by BFS technology
due to Poly ethylene , we validate sterilization at 108 for 60 minutes which achieve F0 around 3
upon validation , it was found that the autoclave did not make 6 log reduction
can we go to Aseptic technique and consider Autoclave as heat treatment at end of process
is it accepted to produce LVP by Aseptic technique
is there other reference rather than ISO 285 that we can go on autoclave validation
this is my question as we do not want to face authority violation in the start up
thanks for your effort and time

Inas

Answer
Inas:

The answer to your problem depends on the regulations in the country where you are selling the product.

In the USA and Europe, if the product is thermostabile, then you MUST use terminal sterilization - aseptic is not acceptable.

I used to make a BFS LVP and had your exact problem. We sterilized at 108oC for 60 minutes and achieved an Fo of 4. FDA allowed this if we filled under almost aseptic fill conditions.

Sorry but I cannot advise further as I do not know yoru local regulator's attitude.

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