Hello,

Want to understand what's the industry approach in a Solid dosage form in respect to Bioburden testing for cleaning validation. Does a Solid dosage form needs to test for bioburden as part of the cleaning validation either as a final rinse or swab?

Purified water is used for final rinse in an automated cleaning cycle. Post cleaning, equipment's are swabbed for API.

We have EM/UM program which test the facility and utilities regularly.

Thank you