is the sterilisation of parenteral products by radiation(for example by gamma ray)authorised by FDA,WHO,EMA or…?
Yes
It is stated clearly in these guidelines
And EU has issued a separate guideline (Annex 12) only for irradiation sterilization
It is a part of Eudralex Vol. 4
The following is the link for EMA sterilization guideline (VIP) and it also includes decision tree for sterilization options
The following is the link for EU Annex 12 sterilization by irradiation
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If i want to use the sterilization cycle of 121C for 8min, what conditions/tests i have to perforn to mimic the 121C for 15 condition?
