How can I get the shared contact area?


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! 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?



The only other way is to measure all product contact parts. Use approximate measurements. Rather over estimate than under estimate.


Thak you Jay for your reply!