Effect of Water Fill volume of Wash/Depyrogenation Mimic on Vial Delamination
| Fill Volume | # Vials with Lamellae |
|---|---|
| 25 μL | 12/20 vials |
| 50 μL | 20/20 vials |
| 100 μL | 20/20 vials |
| 200 μL | 20/20 vials |
| 300 μL | 20/20 vials |
| 400 μL | 14/20 vials |
| 600 μL | 0/20 vials |
| 1000 μL | 0/20 vials |
95% alkalinity 3 cc vials (X95%) filled with varying water volumes followed by 90 min in a preheated oven at 250 °C. Following oven pretreatment, vials were filled with 1 mL 20 mM glycine pH 10 and incubated at 50 °C for 24 h followed by visual inspection using APK unit.