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. 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, 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.
See: Depyrogenation article
The article cites: Tim Sandle, A Practical Approach to Depyrogenation Studies Using Bacterial Endotoxin.; J GXP Compli. 2011; 15(4): 90-96
Posted by Dr. Tim Sandle
