CLEANING VALIDATION

DEAR ALL,

Can you help me please, I want to know if there’s any study available for leachable from the tubings used for the coating equipment. how to validate the tubing cleaning.

thank you

Dear,

As the tubing is non product contact part hence cleaning validation as such not applicable, however the microbial assessment should be done to ensure the microbial limit test.
Basically the tubing are of food grade silicone tube.

Thanks

1 Like

Dear,
Thank you for your response, but according to the bibliography, the direct contact of the tubing with the drug substance at some point in its production raises the possibility that some leachable (plastic-related contaminants) may be present in the finished drug product.

What do you think dear, and if someone has an idea about how to validate this leachable??

thanks

Dear

If required you can get reachable data from the supplier/ vendor.

Thanks