Test Sample Identification
| Package Identification Code | Description | Defect Size |
|---|---|---|
| System suitability | ||
| 5-1 to 5-5 | Master no-defect packages Filled with silicone sealant | n/a |
| 2-1 to 2-10 | Negative-control packages Empty, assembled at WAL | n/a |
| Method development | ||
| 5-1 to 5-5 | Master no-defect packages Filled with silicone sealant | n/a |
| 2-1 to 2-10 | Negative-control packages Empty, assembled at WAL | n/a |
| 13-1 to 13-30 | Negative-control packages Product-filled, supplied by BMS | n/a |
| S-1 | Stopper defect, 21gauge needle single pierce through closure Glass-bead-filled package | 21 gauge puncture |
| S-6 | Stopper defect, single radial cut through flange across land seal Glass-bead-filled package | Closure top radius (Not measured) |
| S-7 | Stopper defect, land seal flange outer edge removed Glass-bead-filled package | Flange width (Not measured) |
| V-1 to V-5 | Vial defect, land seal surface channel Glass-bead-filled packages | 0.74–89 mm (W) × 0.76–0.96 mm (H) |
| V-6 to V-8 | Vial defect, valve seal surface channel Glass-bead-filled packages | 1.12–1.65 mm (W) × 0.27–1.08 mm (H) |
| V-9 to V-11 | Vial defect, land + valve seal surfaces channel Glass-bead-filled packages | Valve: 0.13–1.34 mm (W) × 0.41–0.97 mm (H) Land: 0.88–1.24 mm (W) × 0.16–1.80 mm (H) |
| 27-1-, 27-3- to 27-5- | Vial with hole in neck -X: stopper leg blocking hole -O: open hole; no stopper leg blocking hole Glass-bead-filled package | 2.39–3.38 μm |
| 27-6- to 27-10- | 12.16–14.14 μm | |
| 27-11- to 27-15- | 4.74–5.58 μm | |
| Method validation | ||
| 5-1 to 5-5 | Master no-defect packages Filled with silicone sealant | n/a |
| N-1 to N-70 | Negative-control Product-filled, supplied by BMS | n/a |
| P-1 to P-10 | Vial with hole in neck Product-filled, hand-assembled at WAL | 2.39–3.17 μm |
| P-11 to P-20 | Vial with hole in neck Product-filled, hand-assembled at WAL | 4.36–6.02 μm |
| P-21 to P-30 | Vial with hole in neck Product-filled, hand-assembled at WAL | 12.08–15.04 μm |