* * * INSIGHT * * *

Operational Qualification (OQ)  of A Freeze-Dryer  - Steam Sterilization

By

‡Ana Bacaoanu Ph.D. and Thomas A. Jennings, Ph.D.

ABSTRACT: Whereas a previous INSIGHT dealt with the IQ of the freeze-dryer  (see (INSIGHT Vol. 3 No. 1), this issue will consider the operational qualification (OQ) of the dryer. While IQ verifies that the dryer is constructed in accordance with the manufacturer’s specification and is safe to use by the operator, the product and the facilities, the OQ of the dryer challenges if the dryer does indeed provide a safe environment for the product and the necessary operating parameters to conduct the lyophilization process. We shall once again visit the Validation Department headed by Armondo and see how they deal with challenging the operating performance of the dryer.

Volume 3 Number 3                                                                                      March 2001

10 Pages          No  References          No Figures

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