Dear All,

Our company produce sterile oxygen mask, sterile oxygen nasal canula and sterile nebulizer. For the ETO validation, they defined the SAL as 10-6.

Dose anybody konw how to verify the sterilie acceptable level(SAL)?

Your reply will be very appreciate! :thanx:

CG FENG

ANSI/AAMI/ISO 11135-1994 and EN 550:1994 offer guidance USA and Europe, I'm not sure what would apply to China.

ANSI/AAMI/ISO 11135-1994 and EN 550:1994 offer guidance USA and Europe, I'm not sure what would apply to China.

Thank you, Doug!

Yes, The standard of ISO11135-94 apply to china. But the STD is to specify the validation method but calculate method.

My question is how to demonstrate and/or claculate the result of the validated ETO sterilizing process can comply with SAL 10-6?

I believe the proper way to verify your sterility level is to choose your Process Challenge Device, and infect it with a known quantity of sterility resistent bacteria. When validating the process you check the PCD' s for infection after sterilization. If they are clean you are in the clear.

Have you read EN550? It should tell you what you need to know:
"This standard specifies requirements for the development, validation, process control and monitoring of the sterilization of medical devices using ethylene oxide."
:bigwave:

Thank you Gert!

I think its the proper answer I'm puzzled before.

BI > Native product bioburden
Should demonstrate - BI sterility, - Product sterility and Product bioburden
half cycle approach is very common used.

You have to validate your sterilization cycle according to ISO 11135:2007 (PQ .....by useing BI Bacillus atropheus with nominal population of 10-6)