Dear,all:)
As we clean the equipment with solvent we not only required to do analysis for content product but also for content of solvent uesd for cleaning.
What limit we consider for solvent after cleaning of equipment.
RAHUL
Dear Rahul,
In my opinion no guidelines will suggest to detect the volume of solvent used for cleaning. But because of environmental and safety issues we try to use minimum amount of solvent. In one way regulatory bodies may not like use of excess solvent.
I think you need to demonstrate or validate the minimum amount of solvent for cleaning the residue. The cleaning efficiency can then be proven with rinse and swab samples.
Will like to see other’s view too.
Prashant
Dear Rahul,
in my opinion the approach should be the same as for the solvents used for the manufacturing process, so refer to ICH Q3C for limit setting:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128317.pdf
Best regards
Alfred