QUALIFICATION AND VALIDATION OF DEPYROGENATION TUNNEL: A REVIEW
Journal Title: Mintage journal of pharmaceutical and medical sciences - Year 2018, Vol 7, Issue 2
Abstract
Beyond the usual engineering aspects of validation with regard to specification, installation, commissioning, qualification, and calibration, the two important aspects of validation of dry heat processes are thermal validation and endotoxin validation. Sterility is the most important and absolutely essential characteristic of a parenteral product. Sterility means the complete absence of all viable microorganisms. This review will provide an overview of depyrogenation tunnel qualification and validation protocol with some of more application of it. Depyrogenation devices, such as tunnels, are used in the pharmaceutical industry to prepare components for aseptic filling. To qualify such devices, various pharmacopoeias require depyrogenation devices to be periodically challenged with high levels of bacterial endotoxin. Although the pharmacopoeias state the acceptance criteria, and methods little consideration is given to the practical approach. The review highlight the theoretical concept of depyrogenation and the various tests performed for the qualification of Depyrogenation Tunnels.
Authors and Affiliations
ANKIT. J. JOSHI
Keywords
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