Can Ionized Air in Pharma Pose a Risk of Nitrite Formation

Root Causes Excipients
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Can Ionized Air in Pharma Pose a Risk of Nitrite Formation.pdf (926.1 KB)

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All I can think of seeing this is, is there something in this world that does not lead to formation of nitrosamines?

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Do we need to start considering air as an excipient?

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看清楚，这是减少亚硝胺杂质形成风险的一种技术，不是电离空气会带来亚硝胺风险。该专利摘要如下： 本发明提供了一种在药品制备合成过程中减少亚硝胺的方法。该方法包括通过离子发生装置获得离子化空气，在合成的至少一个步骤中，将药品原料混合物暴露于离子化空气中，并且额外至少再重复一次暴露步骤。将药品原料暴露于离子化空气可减少药品制备中的亚硝胺含量，减少后的亚硝胺含量低于该药品制备中亚硝胺的最大允许含量限值。

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Yes, you are correct, method of ionized air reduces ambient air-related risks. But the ambient air risk still remains as a problem.
There are several pharma unit ops which use large amounts of ambient air in direct contact with the drug product (and excipient) including fluid bed drying and tablet coating.
There are reports of very reactive 2ry amines undergoing nitrosation if just left in ambient air in the laboratory.
Therefore, I think we should start considering air as an excipient.