Module 14: Design Development and Certification of Medical Devices

17/11/2023

STEAM STERILISATION

Some terminology… ● D-value:

– The time needed to reduce the bacterial population by 90% or one log10 at a given temperature.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

17

STEAM STERILISATION

• Z or z-value is used to determine the time values with different D values at different temperatures with the following equation, where T = temperature in °C:

Death curves can be empirically established for all bactericidal agents. The D-value at an unknown temperature can be calculated knowing the D-value at a given temperature provided the Z-value is known.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

18

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