TABLE II

Effect of Vial Processing on Lamellae Occurrence under Accelerated Conditions

Vial Type# Vials with Lamellae
20 mM sodium citrate 100 mM NaCl pH 6.90 45 °C 4 days
    Unprocessed vial0/5
    Washed/depyrogenated vial4/5
10 mM potassium phosphate pH 7.0 70 °C 1 day
    Unprocessed vial0/10
    Washed/depyrogenated vial10/10
20 mM glycine pH 10.0 95 °C 1 h
    Unprocessed vial0/10
    Washed/depyrogenated vial5/10
20 mM glycine pH 10.0 50 °C 16 h
    Unprocessed vial0/10
    Washed/depyrogenated vial9/10

  • 95% alkalinity 3 cc vials (X95%) filled with 1 mL of various buffer solutions and incubated at specified time and temperature followed by visual inspection using APK unit.