Freezedryer Validation


I would like to know what parameters need to be validated during the annual validation/ periodic review of freezedryers.


Dear Sobh

Freez dryers or lypholyzers are qualified on three main inputs predetermined shelf temperature, the pressure inside the chamber and time. If u r talking abt freez drying cycle process validation then it involves formulation characterstics, suitable and collapsible freez drying temperature and selection of different stabilizers.

Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia