TABLE IV

Inspector Qualification Results Using 1-mL Glass Syringes Spiked with Methylene Blue

Test Site Location
Methylene Blue Concentration (ppm)Number of Syringes Per Subset Correctly Identified (total subset population = 3)
Dye Test(s) Performed
Test Site 1Inspector 1Inspector 2Inspector 3
Dye Tests
  • ○USP/PhEur

  • ○ISO

0333
0.1001
0.2003
0.3103
0.4333
Test Site 2Inspector 4Inspector 5Inspector 6
Dye Test
  • ○ Modified USP/Ph.Eur. (higher vacuum)

0333
0.1201
0.2322
0.3333
0.4333
Test Site 3—Trial 1Inspector 7Inspector 8Inspector 9
Dye Test
  • ○ Nonea

0122
0.1130
0.2320
0.3210
0.4230
Test Site 3—Trial 2Inspector 7Inspector 8Inspector 10
Dye Test
  • ○ Modified ISO (higher vacuum)

0233
0.1000
0.2120
0.3221
0.4233
0.5333
0.6333
  • a No dye ingress tests were performed using Trial 1 inspection environment conditions due to inconclusive inspector qualification performance.