TABLE II

Dye Ingress Test Methods

Test Method
USP/PhEur
Modified USP/PhEur
ISO
Modified ISO
Test SiteSite 1Site 2Site 1Site 3
Dye Solution1 g/L (0.1% w/v) Methylene Blue Aqueous Solution1 g/L (0.1% w/v) Methylene Blue Aqueous Solution0.1% w/v Methylene Blue Aqueous Solution0.1% w/v Methylene Blue Aqueous Solution
Vacuum−27 kPa−37 kPa75 ± 5 kPaa63 kPab
Time at Vacuum10 min10 min30 min30 min
Time at Atmospheric Pressure30 min30 min30 min30 min
Dye Verification MethodVisualVisualVisualVisual

  • ↵a Equivalent to drawing a vacuum of about −25 kPa.

  • ↵b Equivalent to drawing a vacuum of about −37 kPa.