Hello,
I´m new on Cleaning Validation. Here in my country we are not ruled by FDA, but our national laws follow their statements as a parameter and soon Cleaning Validation will become an important issue. Therefore I´m developing a Cleaning Validation Protocol, and got into some trouble stablishing a limit aceptance criteria. I read about Le Blanc´s adaptation formula (L3)based on Fourman and Mullen´s criteria. Here is my question… how do I get the shared contact surface area of a equipment train (ESA), if my vendors don´t supply that info? I was thinking that if I can´t get this info so I can´t use that formula!..so which other formula can I use? Fourman´s (I/1000 of the minimun daily dose of the API in a maximun daily dose of the subsequent product)? If I use Fourman´s does it mean that I have to analize for example a placebo batch afterwards looking for my API? Or does Fourman´s formula can be applied to my swab or rinse samples?
tHANK YOU!!!