TABLE VI

ISO Dye Ingress Test versus Vacuum Decay Leak Test—Test Site 1

Defect TypeID CodeaLeak Test Results Air-Filled Syringes
Visual Inspection Resultsb
dP PaPass/FailInspector 1Inspector 2Inspector 3
Controls Tested for IngressA167PNNN
A176PNNN
A187PNNN
A196PNNN
A207PNNN
5-μm Hole10622PNNN
10766FNNY
10879FNYY
10944FNNY
11042FNNN
10-μm Hole121205FYYY
122175FYYY
123260FYYY
124221FNNY
125154FNNN
15-μm Hole136388FYYY
137346FYYY
138335FYYY
139337FYYY
140301FYYY
  • a Holed syringes are identical to those used for Part 1, ASTM precision and bias studies.

  • b Y = dye seen, N = No dye seen.