Effect of Depyrogenation Mimic Procedure and the Role of Water
Vial Pretreatment | # Vials with Lamellae |
---|---|
Unprocessed vials | 0/50 vials |
Washed and depyrogenated vials | 50/50 vials |
Dry vials (no water added) + 250 °C oven for 90 min | 0/50 vials |
Vials filled with 200 μL water + 250 °C oven for 90 min | 50/50 vials |
95% alkalinity 3 cc vials (X95%) filled with 1 mL 20 mM glycine pH 10 and incubated at 50 °C for 24 h followed by visual inspection using APK unit.