Table 5 Freeze-drying recipe for part 2, gravimetric verification runs for lyophilisers (Lyo) 02 and 03
Phase | Shelf Temp (°C) | Vacuum pressure set point (µBar) | Step hold time (HH:MM) | |
|---|---|---|---|---|
Freezing | −50 | N/A | 2:00 | |
Drying — verification cycle 1 | −20 | Lyostar II | 63 | 10:00 |
Lyo 02 | 28 | |||
Lyo 03 | 31 | |||
Drying — verification cycle 2 | 20 | Lyostar II | 182 | 06:00 |
Lyo 02 | 78 | |||
Lyo 03 | 104 | |||