Table I
Dye Ingress Requirements for Aseptic Drug Product in Vials
Test Requirements
USP 34 <381>, EP 3.2.9
ISO 8362-5, Annex C
Dye Vacuum
–27 kPa
–25 kPa
Time at Vacuum
10 min
30 min
Time at Atmospheric Pressure
30 min
30 min