Hallo all,
My question is like this: If we have validated Terminal sterilizer with a product of particular specific gravity, and then going to use different product with different Specific gravity then do we need to validate again our T. sterilizer for that product and if yes what might be range of Sp. gravity for that will it be 10%.
Hoping your immidiate response,
Pritesh Bhosale.
[quote=pritesh]Hallo all,
My question is like this: If we have validated Terminal sterilizer with a product of particular specific gravity, and then going to use different product with different Specific gravity then do we need to validate again our T. sterilizer for that product and if yes what might be range of Sp. gravity for that will it be 10%.
Hoping your immidiate response,
Pritesh Bhosale.[/quote]
Hi Pritesh,
I don’t think there is any impact of the specific gravity on terminal sterilization process.
In my opinion, if sp gravity changes the enthalpy shall change considerably.
Logically heat is the function of volume of mass which shall include sp gravity.
For terminal sterilization, we may reduce the volume/quantity of validated product in sterilizer without changing pattern of loading but essentially not different product which is not validated.
Rgds
Ravindra