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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:

Regards,
Felisia :wink:

Felicia,
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.

ANil

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,

Felisia;)

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.

Anil

Dear Anil,
Thanks for your explaination, Anil.

Regards.

Felisia