In depyrogenation process we set 250oC for 30 minutes, my doubt is if we set 170oC for 4 hours, there 3log reduction will be occur??? Can you please clarify my doubt.
You can use any combination of temperature and time to achieve 3 log reduction but validate the combination that you actually use in the manufacturing process.
After validate by our manufacturer requirement, time and temperature can we consider as that cycle is a depyrogenation cycle.
On satifacory qualification of achieving 3 log reduction with the preset time and temperature is justifiable .
Time and temperature can be set based on the durability of the material and product being sterilized .
If you want reference you can go through PDA 3 will help you more like others.
any one attached the material regarding this question