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?
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