* * * INSIGHT * * *

Transferring the Lyophilization Process from One Freeze-Dryer to Another

In previous issues of INSIGHT I have  (a), considered the various aspects of the lyophilization process (Vol. 1 No. 9,   Vol. 2 No. 1,  Vol. 3 No. 2); (b), discussed various aspects of the freeze-dryer and its instrumentation (Vol. 1 No. 1, Vol. 1 No. 4, Vol. 1 No. 6,  Vol. 1 No. 7,  Vol. 1 No. 8);  (c), reviewed the validation of the process (Vol. 2 No. 3,  Vol. 2 No. 7),  and  (d), examined the various aspects of IQ and OQ (Vol. 2 No. 11, Vol. 3 No. 1, Vol. 3 No. 3, Vol. 3 No. 5, Vol. 3 No. 7).  While admittedly these INSIGHTs do not individually nor collectively represent a comprehensible thesis on the lyophilization process and its associated equipment and instrumentation., they do provide a foundation for considering the transfer of a lyophilization process from one dryer to another. Therefore, the main objectives of this INSIGHT is to not only outline the steps necessary for such a  process transfer but also show the interrelationship that exists between the formulation, the various process parameters and the configuration of the freeze drying equipment.

Volume 4 No. 7                                                                                           July 2001

7 Pages          5  References          No Figures

[How to obtain a complete copy this INSIGHT]  [Return to Phase Home Page]