is this statement true?
A full batch of sterile product have ‘zero’ particles.
No it is not possible.
In visual inspection of liquid injection ,some injection can pass with foreign particle if it is invisible due to fine size.
what is the critetia of pass n fail acc to BP,usp on basis of particles?
mean how much number of rejected ampuled decide the Fate of batch?
Pls follow ANSI table for AQL.
1 Like