Modified USP/Ph.Eur. Dye Ingress Test versus Vacuum Decay Leak Test—Test Site 2
| Defect Type | ID Codea | Leak Test Results Air-Filled Syringes | Visual Inspection Resultsb | |||
|---|---|---|---|---|---|---|
| dP Pa | Pass/Fail | Inspector 4 | Inspector 5 | Inspector 6 | ||
| Controls Tested for Ingress | B6 | 8 | P | N | N | N |
| B7 | 8 | P | N | N | N | |
| B8 | 8 | P | N | N | N | |
| B9 | 8 | P | N | N | Y | |
| B10 | 8 | P | N | N | N | |
| 5-μm Hole | 111 | 64 | F | Y | Y | Y |
| 112 | 54 | F | N | N | Y | |
| 113 | 88 | F | Y | Y | Y | |
| 114 | 56 | F | N | N | N | |
| 115 | 46 | F | N | N | Y | |
| 10-μm Hole | 126 | 192 | F | Y | Y | Y |
| 127 | 184 | F | Y | Y | Y | |
| 128 | 186 | F | Y | Y | Y | |
| 129 | 301 | F | Y | Y | Y | |
| 130 | 194 | F | Y | Y | Y | |
| 15-μm Hole | 141 | 352 | F | Y | Y | Y |
| 142 | 356 | F | Y | Y | Y | |
| 143 | 346 | F | Y | Y | Y | |
| 144 | 445 | F | Y | Y | Y | |
| 145 | 371 | F | Y | Y | Y | |