Is there any special necessity of taking line clearance if yes what type of cleaning should be performed please see the below conditions revert with the best possible method
Product: pantoprazole delayed release tablets usp 40 mg
Coating to be applied: enteric coating followed by sub coating
Condition:sub coating was completed can we give enteric coating without unloading the tablets from the coating pan if yes what about the compulsion of getting line clearance that too for colour change over or product change over
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Yes, line clearance is mandatory to cross check the cleanliness of the equipment and area and removal of the remaining material of the previous batch.
It is same batch how can we use the term previous batch after completion of subcoating we are applying enteric coating on the same tablet…
What are the check points for removal of equipment from running intermediate API plant
I would assume that the different intermediates (tablet core/subcoated tablet/ coated tablet ) do not have the same batch number?
Still you need to verify that the equipment used is clean and any remnants of the previous shift or batch are removed.