Reaching out to our community for advice. I learned about a couple of organizations tracking down their nitrosamine sources to cleaning agents used in their GMP equipment. Have anybody experienced or considered this in their cleaning protocols? Thanks
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Wir haben unsere Reinigungsmittelhersteller ebenfalls angeschrieben und diese bewerten lassen, um das Gesamthaft zu betrachten
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Thanks @Mandy22. Reaching out to our community members @trust_user_a @trust_level_1 for any insights on ‘cleaning agents’
What I have asked some of my clients to do is to look for potential nitrites in the cleaning agents.
Of course there are some of the chloro compounds which could catalyze the nitrosation reactions. This is again a very nebulous area and that is why, where there is possibility of secondary and tertiary amines being present, it is best to look for the corresponding nitrosamines in at least a few lots and whenever something related to equipment, reagents, processing aids or cleaning process is changed.
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I agree from my point of view, composition of cleaning agents and if applicable passivation agents needs to be evaluated. Alos cleaning validation can be checked or revised. If cleaning and purging process is robust no residues should be in the system from what ever could be introduced by the cleaning agent. But definately this should be evaluaetd and documented
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On the other hand, residual amount of detergent is trace at cleaning validation. Even trace amount of nitrite salts contains in detergent, it will be perfectly washed off, I suppose. To check the ingredients of detergent is useful for risk assessment , but the risk of nitrites in detergent does not look so high in many cases.
What do you think, guys?
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As a risk assessment if possibility of removal of detergent is confirmed, risk of nitrites could be eliminated. Primarily pH in water rinse is one of simple test to check traces of detergent.
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In addition to the points mentioned by my colleagues, we have also come across, not only the issue of residual nitrite from these agents, but also the possibility of a direct nitrosamine introduction being through the cleaning agent. The cleaning agent contained considerable levels of triethanolamine, and the conditions presented by the manufacturer could be favorable to the NDELA formation.
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I am curretly facing this challenge. We have a couple of products that we ousource our production. While carring a risk assesment analysis for them, I’ve found out that triethanolamine is present in a concentration of 1-3% (w/w) on the cleaning agent they’ve used on the process.
The majority of products don’t have any risk associated to them, they are not amines or anything related. The only source of an amine would bethat one found on the clening agent.
Does anyone have some experience or new insights about that discutions?
I would appreciate any help on the matter
We look at the cleaning agents and process for any trace amounts of contributors to nitrosation for our assessments. To mirror comments already made, we also look at the rinse process to ensure as much of the trace amounts are removed as possible. One area we are needing help with is passivation. One of our suppliers needs to perform passivation with a nitric acid solution to help with a yield issue and impurities. However, they have stated that their process cant ensure low enough levels of nitric acid to a ppb level. Does anyone have experience with this? They said passivation with citric acid is not adequate but they are concerned that low levels of nitric acid could lead to nitrosamines with these materials. Does anyone have recommendations for a company who we can use to contract tge passivation and cleaning work
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