Table 11.
Optimized lyophilization cycle.
Thermal Treatment | Primary Drying | ||||||
---|---|---|---|---|---|---|---|
Step | Temperature (°C) | Time (min) | Ramp(R)/Hold (H) | Step | Temperature (°C) | Time (min) | Ramp(R)/Hold (H) |
Shelf Load Temp 5 °C | |||||||
1 | 5 | 30 | R | 1 | −20 | 120 | R |
2 | −15 | 30 | R | 2 | −20 | 1200 | H |
3 | −15 | 120 | H | 3 | 0 | 180 | R |
4 | −40 | 60 | R | 4 | 0 | 300 | H |
5 | −40 | 300 | H | 5 | 10 | 60 | R |
6 | 10 | 240 | H | ||||
7 | 30 | 60 | R | ||||
8 | 30 | 180 | H | ||||
Secondary drying | 30 | 120 | H |