Sterilization Holding Time for Terminally Sterilized Products: Continuous or Cumulative?
GMP

For terminally sterilized products, is the required sterilization holding time required to be continuous and uninterrupted, or can it be cumulative?
For example:
Suppose the standard sterilization time is 15 minutes. If the process stops at 7 minutes and the temperature drops, then after the temperature recovers to sterilizing conditions, sterilization continues for another 8 minutes.
Is this cumulative approach (7 min + 8 min = 15 min) acceptable?
Or must sterilization restart from the beginning and run 15 minutes continuously?

2026-03-13 10:34 Zhhui1     
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No, the cumulative approach (7 min + 8 min = 15 min) is absolutely not acceptable. The sterilization holding time must be continuous and uninterrupted at or above the validated specified temperature.

If the temperature drops below the validated sterilization temperature (even for a moment), the cycle is considered to have failed, and you must restart the timing from zero once the temperature recovers—provided the product can even withstand the additional heat exposure.

2026-03-18 18:37 EllenZ     
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Sterilization is a function of both time and temperature which should be fully qualified. If the temperature drops, you should investigate on the root cause. It's commonly happened or a rare case. Normally, to adding 7 minutes of initial exposure at the correct temperature cannot be added to the 8 minutes after recovery because the interruption broke the "sterilization phase." 

You cannot assume the microbial kill is simply "plus" of the time. Typically we would consider the restart the process instead of calculate the total cumulative time.

BTW, some sterilizer have the function to automatically calculate the "total" time in their default operational recipe, which should be carefully.

2026-03-17 09:38 马大修     
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