Cleaning Validaiton Requirements for equipment processing film coated tablets


Could you please advise what is the industry standard for cleaning validation requirements for process equipment invovled in the processing of film coated tablets? As tablets are film coated on this equipment is there a need to perform cleaning validaiton swabbing for active? The only risk being that active may be exposed on the line if there are any coating defects e.g. peeling, chipping etc.

Many Thanks,

Dear Byrnea,

as in every validation, you have to prove your assumptions. As far as i know, industry standard is to validate cleaning of all the equipment train, even if it is in contact only with film coated tablets or capsules. Probably, and based on a risk assessment which may show that the risk in case of film coated tablets is lower than with uncoated tablets, you could user fewer sampling points, but nevertheless there is a need to demonstrate that the equipment is clean.



Dear friends,

Well I think that risk is involved in cases of Enteric coating solution application in the same equipment followed by normal film coating.
According to me a through cleaning programme is required as traces of API
must be threre while inching uncoated tablets.

Best regards,