Evaluating Functional Equivalency as a Lyophilization-Cycle Transfer Tool

Currently, there are no common industry practices or regulatory guidances available that can be used to technically evaluate the suitability of different lyophilizer units for the successful transfer of lyophilization cycles. This study describes a comprehensive methodology for establishing function...

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Bibliographic Details
Published in:Pharmaceutical Technology 2009-09, Vol.33 (9), p.54
Main Authors: Mungikar, Amol, Ludzinski, Miron, Kamat, Madhav
Format: Magazinearticle
Language:English
Subjects:
Comparative analysis
Freezing
Methods
Pharmaceutical industry
Process controls
Studies
Temperature
Online Access:Get full text
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Summary:Currently, there are no common industry practices or regulatory guidances available that can be used to technically evaluate the suitability of different lyophilizer units for the successful transfer of lyophilization cycles. This study describes a comprehensive methodology for establishing functional equivalence between different lyophilizers, which can then be used to predict suitability of cycle transfers. The authors discuss the comparative and operational qualification methods that were used. Results show that the proposed methodology provides the necessary basis to establish functional equivalence between different lyophilizer units. Once functional equivalence is established, it is expected that testing requirements and process validation protocols can be optimized, resulting in considerable savings of time, resources, and capital. [PUBLICATION ABSTRACT]
ISSN:1543-2521
2150-7376