Hello Sir, Can you please make a case study of (1) What to do if Last 30 min print not printed of online particle counter during aseptic filling Can we file NCR, what's is the impact assessment?? (2) What to do if HEPA power off during aseptic filling (3) What to do if after completion of packing activity rejection observed out of limit . We file NCR but what type of investigation we do if black particle observed out of limit ?? (4) How can we establish limit in type of rejection in filling and also in packing ?? (5) Can we incubate volume setting vials in media fill ???
Hello Sir, Can you please make a case study of
(1) What to do if Last 30 min print not printed of online particle counter during aseptic filling
Can we file NCR, what's is the impact assessment??
(2) What to do if HEPA power off during aseptic filling
(3) What to do if after completion of packing activity rejection observed out of limit .
We file NCR but what type of investigation we do if black particle observed out of limit ??
(4) How can we establish limit in type of rejection in filling and also in packing ??
(5) Can we incubate volume setting vials in media fill ???