Cleaning validation for sampling tools


(Trí Nguyễn) #1

Hi everyone,
How to conduct cleaning validation for sampling tools. Especially raw material sampling tools.
Can I calculate MACO based on Toxicity, LDD and Maco10ppm?


(Sunil R. Budhkar) #2

I suggesst for sampling tools, criterion of 10 ppm should work. This is because, there may not be direct impact of raw materials on toxicity specially for excipientsale. However, for active raw materials 10 ppm criterion should work. I further suggest that sampling tools for actives/APIs should be dedicated for every active / API, like dispensing scoops or devices.


(Trí Nguyễn) #3

Thank you for your comment, Sir


(Sunil R. Budhkar) #4

You are welcome.