Hi to all, and thanks in advance for your answers.
So, I have to validate the cleaning process of the injectables/oftalmics area in the facility where I work. My bet is to use rinse sampling and TOC analysis.
It is going to be a tough work, since no cleaning procedure is close from especificity (“rinse with abundant water until it seems clean”).
Anyway, after all that gets done, I need to validate recovery of the sampling metod. As far as I know, it is easier to test recovery with swab sampling (althoug more variable), since I only need to spike some coupon of the same material of the equipment, and then sample and test recovery. But what happens when you have 4 kind of materials in the equipment (steel for containers and needles, silicon for hoses, glass for temporary containers, and even PET for transportation containers)? Do i have to test recovery on every material or only in the “worst case”? Also, how do I test recovery on a hose (or in any close system, like pipes)? Do I still to have to run a test recovery on them if all hoses are “product specific”?
Thanks for your advice