Lyophilization Recipe

Existing Recipe Trial Recipe

Temp. (°C) Ramp Soak (min) Pressure Temp. (°C) Ramp Soak Pressure
(min) (mbar) (min) (min) (mbar)
Freezing Freezing
-40 60 120 0 -40 60 90 0
-15 20 120 0 -15 20 90 0
-40 100 180 0 -40 80 150 0
Primary Drying Primary Drying
-20 30 90 0 -20 30 90 0
-10 20 900 0.1 -10 20 590 0.1
0 15 180 0.1 0 15 330 0.1
Secondary Drying Secondary Drying
25 30 225 0.075 25 30 180 0.075
35 15 405 0.075 35 15 270 0.075
35 1 270 0 35 1 120 0

Previous recipe

Temp. (°C) Ramp Soak (min) Pressure

(min) (mbar)
Freezing
-40 100 120 0
-15 20 120 0
-40 30 120 0
Primary Drying
-20 20 60 0
-10 15 600 0.1
0 15 120 0.1
Secondary Drying
25 15 150 0.075
35 30 270 0.075
35 1 120 0
100 120 0
20 120 0
30 120 0 8.5

20 60 0
15 600 0.1
15 120 0.1 13.83

15 150 0.075
30 270 0.075
1 120 0 9.76
Moisture Content Test Result of Cycle Time Reduction Trial Batch

Sample No. Moisture Content (%)

T1 1.49

T2 1.62

T3 3.5

T4 2.06

T5 2

T6 1.7

T7 1.88

T8 2.55