USP/Ph.Eur. Dye Ingress Test versus Vacuum Decay Leak Test—Test Site 1
| Defect Type | ID Codea | Leak Test Results Air-Filled Syringes | Visual Inspection Resultsb | |||
|---|---|---|---|---|---|---|
| dP Pa | Pass/Fail | Inspector 1 | Inspector 2 | Inspector 3 | ||
| Controls Tested for Ingress | A6 | 11 | P | N | N | N |
| A7 | 10 | P | N | N | N | |
| A8 | 12 | P | N | N | N | |
| A9 | 9 | P | N | N | N | |
| A10 | 9 | P | N | N | N | |
| 5-μm Hole | 106 | 25 | P | N | N | Y |
| 107 | 71 | F | N | Y | Y | |
| 108 | 80 | F | N | Y | Y | |
| 109 | 43 | F | N | N | N | |
| 110 | 42 | F | N | N | Y | |
| 10-μm Hole | 121 | 217 | F | Y | Y | Y |
| 122 | 177 | F | Y | Y | Y | |
| 123 | 264 | F | Y | Y | Y | |
| 124 | 231 | F | N | N | Y | |
| 125 | 161 | F | N | N | N | |
| 15-μm Hole | 136 | ABORT | F | N | N | Y |
| 137 | 344 | F | Y | Y | Y | |
| 138 | 342 | F | Y | Y | Y | |
| 139 | 350 | F | Y | Y | Y | |
| 140 | 281 | F | Y | Y | Y | |