Product Sterilisation- Temperature mapping

Validation
#1

Dear All,

How do you conduct temperature mapping of manfacturing vessel if you are manufacturing different products having different product sterilisation temperature and time.

  1. Which product-(Placebo base) you will choose?
  2. What will be your approach to conduct temperature mapping.
  3. Also define the Rationale.
    4.How many probes you will use.

Thanks.

#2

If all other conditions of the sterilization process are similar for different products except sterilization temperature then you may follow matrixing / bracketing approach by selecting worst case scenario for temperature mapping. However, heat penetration studies at each temperature and loading pattern must be conducted for all products’ sterilization cycles.


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