Pharmaceuticals/Media Fill

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Question
Hello I'm writing to you to get your profesional opinion, about a nonconformity that i received on my last audit. The auditor said that my Media Fill is invalidated because i used Nitrogen for the filtration of my culture media. But I just use Nitrogen to "push" the media, i didn't fill ampoules with nitrogen, so there must be enough air in the ampoule for microbes to growth.
He said that he based on PICS 2013 guidelines, and i read it but the guideline it's not very clear for me about this item.

Thank you very much and please excuse my english

Answer
During a media fill you need to EXACTLY replicate the commercial manufacturing process.

If in commercial manufacture you use Nitrogen to "push" product through the filter, then you can use it to push the media through the filter - if you do not, then you cannot.

I hope this helps.

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Michael Anisfeld

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