Container Closure Integrity Testing Results of 2 mL Vials with Serum Stoppers Under Static and Under Dynamic Conditions, as Measured by the ThermCCI Method at Variable Temperatures
| Storage Conditions: Static | Helium-Leak @ RTa (Number of Leaking Vials/Total Vials) | Helium-Leak @ −20°C (Number of Leaking Vials/Total Vials) | Helium-Leak @ −60°C (Number of Leaking Vials/Total Vials) |
|---|---|---|---|
| RT | 0/10 | 0/10 | 2/10 |
| −20°C | 0/10 | 0/10 | 2/10 |
| −75°C (*) | 0/10 | 0/10 | 3/10 |
| Storage Conditions: Dynamic | Helium-Leak @ RT (Number of Leaking Vials/Total Vials) | Helium-Leak @ −20°C (Number of Leaking Vials/Total Vials) | Helium-Leak @ −60°C (Number of Leaking Vials/Total Vials) |
|---|---|---|---|
| RT | 0/10 | 0/10 | 2/10 |
| −20°C | 0/10 | 0/10 | 5/10 |
| −75°C (*)b | 0/10 | 0/10 | 2/10 |