I am doing cleaning validation on a tablet press after compressing Acetaminophen.
I did 3 cleaning studies.
We took swab samples from 20 different locations 5cmx5cm ea location
all results cam back less than 10 ppm
after study 3, I cleaned the equipment and compressed a placebo tablet( all exipients) same weight as acetaminophen tablet 325mg and assayed the placcebo tablet for Acetaminophen. came out 0.280mg per tablet.
Can you do the MACO calculations after study 3?
How it should be done in this case given that the placebo tablet is the same as Acetaminohen taablet in weight?