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_user_b 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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