I received a couple of inquiries this week about any knowledge of nitrosamines assessment in Poly bags? Way back, I learn about lab suppliers providing nitrosamines assessment on consumables, but it’s my first hearing about poly bags used to store APIs or in-process dosage forms. Are you doing such considerations? Thx
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we have a risk assessment report for the packaging used at our site. our suppliers also provided statements regarding nitrosamines in the packaging materials that we purchase.
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This wasn’t something I hadn’t really been considering, until reading this question and pondering where it could be an influence.
Is there an argument that potential catalysts of the nitrosamine formation could leach from the bags into the product? Formaldehyde? Metal ions?
I would like to think that it wouldn’t be an issue for solid dose products, but liquid products could be a very different prospect.
I see so little discussion on liquid products!
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We requested nitrosamines statements from all of our packaging vendors, poly bags and glass alike. This wasn’t because we suspected there would be a risk (I would assume there isn’t given the “construction” of the products), rather it was for completeness’ sake. We actually did have one vendor state there was a possibility there could be nitrites in their bags, although there was no good explanation as for why.
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Oh, and poly bottles and caps, too.
This was a discussion I had in a E&L meeting several years ago.
We´re doing some cross analysis together with one of our sister companies at the group.
I will update you if possible.
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Yes, this has been asked by our customers. At present we are approving poly bags used for packing of APIs, based on supplier declaration for Nitrosamines.
We are trying to get it tested.
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