Difference between sterilization and depyrogenation
1 Like
Depyrogenation is a process to eliminate pyrogens from injectable solutions. Whereas sterilization is the process where all pathogenic or non-pathogenic microorganisms, bacteria, fungi, protozoa are destroyed by heat, pressure, and vapourization.
Both processes are highly sensitive results-oriented. The difficulty level in depyrogenation vs sterilization is almost similar, some times depyrogenation is found tougher.
Depyrogenation is performed in special capacity ovens and tunnels, where we can depyrogenate or sterilize the glassware which is used for filling pharmaceutical injectables.
Depyrogenating ovens and tunnels eliminate the endotoxins by direct heat through physical destruction. In this process, the molecule of endotoxin is killed at high temperatures.
1 Like
In agreement with Mr. Sunil.
Also, from a validation perspective, validated depyrogenation processes via dry heat can also be considered as validated sterilization process; since dry heat resistance of microorganisms is lower compared to dry heat resistance of bacterial endotoxins.
This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.