Product change over cleaning

Required opinion on to check the the content of nitrosamine after product change over cleaning???

1 Like

Our concept is based on the solubility of the drug substance residue and the nitroso-derivative of the drug substance. If the nitroso-derivative is soluble in the cleaning solvent for the drug substance, then there is no impact to the next product in the change-over.


Thanks for valuable inputs

Best of our knowledge with cleaning procedures, suggests that MACO value should be greater than LOQ of the target residue which is drug substance associated nitrosamine in this case. We know very well That nitrosamine impurities are well controlled by drug substance spec and during mfg process very minimal chances of its further generation as it is time based very slow reaction.
Hence it might not be an issue during changeover or required any extra effort from cleaning part.

1 Like