Can any one tell me how do you perform cleaning validation studies for the sampling booth and dispensary when the only product contact parts are the scoops?
Is it necessary if scoops and conatiners are already included in the equipment train.
Jay
Dear Jay,
it should not be necessary to chemically validate cleaning of dispensing booths, but i’ve had some questionings about this during inspections. The funny part was that the inspectors did not require the cleaning validation of the non product contact parts of the equipment, but the cleaning validation of walls and roof. The agreement was to swab test some locations of the walls and roof and use the same accepted contamination level than for the equipment, even if this made no sense from the scientific standpoint. In my opinion, the documented routine check for visual cleanliness made after cleaning of walls, roofs and dispensing booths should be sufficient.
Best regards
Alfred
Hai Jay,
No need to perform cleaning validation during dispensing stages, to avoide auditor points (for not doing swabs) you can use dedicated SOOOPS/SPOONS/ for dispensing of APIs. & also you can use disposable(sterile) scoops.
Hope it will help you.
Cheers,
Ravi.B