Dear all member as well as grahhmme sir, alfred
we are performing the Cleaning validation by HPLC method.
now a days i listen more about TOC. CV sample can run on TOC.
so i want to swith over to TOC, so how can i start up the procedure. please if you have suggestions thenn do guide me.
also the MACO calculation will remain same as for HPLC or it may differ from it.
Dear Nimesh,
to begin with, the MACO calculation will be the same, what changes is the amount of contamination you will find in the equipment, because as an unspecific method, TOC computes as contamination whichever organic carbon it finds. This is why, too, inorganic molecules are not detected or with low analytical recovery: calcium carbonate, aluminium and magnesium hydroxide from antiacids, cleaning agents based on sodium hydroxide or phosphates, etc. are common cleaning validation targets that cannot be detected by TOC. The probably biggest disadvantage of TOC is that, obviously, you cannot sample with organic solvents so you are limited to sample with water chemical entities which, as the worst case, are insoluble in water, so for high MACOs you may get low recoveries. The biggest advantage is that you don’t need to validate the analytical method. The procedure itself is relatively simple provided all the glassware is thoroughly cleaned with an oxidant to remove traces of organics, and you use TOC-free water and swabs to sample. It is advisable to run blanks of water exposed to the same environment as the samples, to eliminate environmental background.
Best regards
Alfred