Hot air aterilizer qualification

In case of qualification hot air sterilizer, I want to know its abilility to inactivated endotoxin. I think the mechanism is similar to biological test for autoclave. But, I’m a little bit confused about the detail. Should I use CSE (Endotoxin) or the water flushing (water that I used to flush equaipment which I sterilized with hot air) to test with the LAL reagent? Any idea or information about this qualification?
Your reply is realy helpfull. Thanks a lot before. :slight_smile:

Felisia :wink:

You have to demonstrate 3 Log reduction in the Endotoxins as per FDA requirement, You have to load the material with the 10 ^ 4 EU endotoxins . Again check the endotoxins after depyrogenation and calculate the endotoxin reduction after depyrogenation,

Hope this will solve your the query.


Dear Anil,
Thakns for your information.
But, I’m a little bit confused about 3 log reduction. If I use 10^4 endotoxin as bioburden then by depyrogenatin cycle, the concentration of endotoxin becomes 10^1, is it right?
If LAL reagen have sensitivity 0.25 EU/ml, that endotoxin (after depryrogenation) still show positive result in gel clot test?
Any recommnedation about it?
Because, I have so many option about bioburden of endotoxin.
Any information is willing to impart would be appreciated. Thanks.

Best regards,


You are right.
But the requrement is, the depyrogenation cycle shall show more than 3 log reduction. By using the said lysate you will be able to demonstrate more than 4 log reduction . This will comply to the requirement. By using 10 3 vial yuo will be able to demonstrate slighly more reduction in endotoxin thathn requirement.


Dear Anil,
Thanks for your explaination, Anil.