Z value in Fh calculation

Hello,

Does anyone know of a literature reference supporting a Z value of 46.4 deg C in accumulated lethality calculations for depyrogenation? I know it is the standard value, but I cannot find a literature citation to support it.

Thanks,

Joe

PDA TECHNICAL REPORT 3 :Validation of Dry Heat Processes Used for Sterilization and Depyrogenation

PDA TECHNICAL REPORT 7: Depyrogenation
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