Lyophilisation targeting defined residual moisture by limited desorption energy levels

摘要

A process of freeze drying of an essentially aqueous solution comprising at least one first step having a first temperature and pressure level (i.e. primary drying phase) and at least one second step having a second temperature and pressure level (i.e. secondary drying phase) following the first step, wherein in the secondary drying phase limited desorption energy input is applied.

主权项

1. A process of freeze drying an essentially aqueous solution comprising the sequential steps of
a) subjecting the solution to a primary drying phase at a first temperature and pressure level to obtain a product; and b) subjecting the product to a secondary drying phase at 0.01 mbar and a temperature range from −5° C. to +3° C. for at least 3 hours; wherein a limited desorption energy input is applied in the secondary drying phase; to obtain a lyophilized product having a predefined target rest moisture in steady-state conditions of 0.79-1.14%.