TABLE VII

Dye Ingress Test Results for All Combinations Tested

Samples TypeSample LabelVisual: UV-Light
Stopper A, Low Parameter Settings
 White Seal, 100 VialsStopper A-W-L-001-100Faileda
 Red Seal, 100 VialsStopper A -R-L-001-100Pass
 Dark Blue Seal, 100 VialsStopper A -B-L-001-100Pass
Stopper A, High Parameter Settings
 White Seal, 90 VialsStopper A -W-L-101-189, 200Passb
 Red Seal, 100 VialsStopper A -R-L-101-200Pass
 Dark Blue Seal, 100 VialsStopper A -B-L-101-200Pass
Stopper B, Low Parameter Settings
 White Seal, 99 VialsStopper B-W-L-001-100Passc
 Red Seal, 100 VialsStopper B-R-L-001-100Pass
 Dark Blue Seal, 100 VialsStopper B-B-L-001-100Pass
Stopper B, High Parameter Settings
 White Seal, 100 VialsStopper B-W-L-101-200Pass
 Red Seal, 100 VialsStopper B-R-L-101-200Pass
 Dark Blue Seal, 100 VialsStopper B-B-L-101-200Pass

  • ↵a One vial failed the dye leak test; there was no sign of broken glass.

  • ↵b Only 90 samples were available for evaluation.

  • ↵c One vial was missing a stopper.