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.

#3

Thank you so much Mr. Sunil and wish to appreciate for answering valuable questionnaires.

Could you please explain more about heat penetration studies and loading pattern,
as for example if we are manufacturing sterile cream & gels.

Thanks