Friday, 26 October 2018

European Pharmacopeia to update chapter of F concept for heat sterilization

The change affects chapter 5.1.5 “Application of the F concepts to heat sterilisation – 50105”.

This chapter has been revised in order to add a definition of FH for dry heat sterilization and how to calculate it. It is common practice to determine FH values for dry heat processes in a similar manner to F0 for steam sterilization.

Heat sterilisation can be differentiated into 2 types, according to the water or steam content during the sterilisation phase: moist heat sterilisation using saturated steam or water heated to the sterilisation temperature; and dry heat sterilisation using hot air with a moisture content so low as to have an insignificant biological activity.

The new chapter is expected to come into force early in 2019.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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