Packaging Components, Sample Size, and Targeted Test Conditions Used in the Study
| Vial | Stopper (D21-7S) | Crimp Seal (Skirt) Length | Targeted Residual Seal Force, RSF (lbs) | Number of Samples per RSF Conditiona | Helium Leak Rate Test Temperature | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Size | Type | |||||||||
| 2 mL | Crystal Zenith® plastic vial | Serum | 7.3 mm | 2–3 | 5 | 10 | 15 | 20 | 20 | −80°C |
| 2 mL | Corning Valor® Glass | Serum | 7.3 mm | 2–3 | 5 | 10 | 15 | 20 | 20 | −80°C |
| 10 mL | Crystal Zenith® plastic vial | Serum | 6.6 mm | 2–3 | 5 | 10 | 15 | 20 | 20 | −80°C |
| 10 mL | Corning Valor® Glass | Serum | 6.3 mm | 2–3 | 5 | 10 | 15 | 20 | 20 | −80°C |
↵a 20 samples per time point (0, 1, 4, 7, 10, 18, and 29 days).