Historical
PDA TR 03-2013
Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
This technical report provides information to the manufacturers of pharmaceutical products for validating dry-heat depyrogenation and sterilization processes. The concepts and methods presented within this technical report are not intended to be a regulatory standard, but rather as points to be considered during the validation of dry-heat processes. Other technically equivalent methods may exist and may be used if they can be supported by sound scientific methods.
Content Provider
Parenteral Drug Association [pda]
