What is the CAPA, If the vent filter (storage vessel) integrity fails?
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No need of CAPA,pls mention in sop that if any filter fail in integrity,it will be replaced and follow this procedure.
No need to capacity. Replace with new one
if the filter fails before the batch then no issue we can replace if it’s failed after completion of the batch then what are the steps we should take for the batch
If vent filter or product filter fail in post integrity, replace the filter with new one.take the pre integrity.place it on vessel.refilter the solution.
You should raise incident for process of refiltration.
after completion of filling vent filter integrity is performed in that case we can’t do filtration
After filtration,perform post integrity test of vent filter which is attached with manufacturing tank.if it is passed in post integrity then start filling process.
If vent filter of filling vessel failed in post integrity (rare possibility) there may be air contamination in product. if filled product fail in sterility test,batch will be failed.