TABLE VI

Effect of Depyrogenation Mimic Procedure and the Role of Water

Vial Pretreatment# Vials with Lamellae
Unprocessed vials0/50 vials
Washed and depyrogenated vials50/50 vials
Dry vials (no water added) + 250 °C oven for 90 min0/50 vials
Vials filled with 200 μL water + 250 °C oven for 90 min50/50 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.