Help: EO sterilization & bioburden
ms_comp at netvision.net.il
Sun Nov 23 16:40:54 EST 1997
Please help with the following problem:
Our company manufactures a medical device (single use instrument cover).
The device is sterilized by a contract sterilizer. Sterilization is by
Ethylene Oxide. Process was validated per EN 550. At validation time
bioburden was 10 to 15 CFU per product unit.
My question is: How high may product bioburden go without invalidating
the sterilization process? I know that the lower the bioburden the
better but I still need to set some practical limit for our production
people without imposing undue difficulties.
All help will be appreciated.
More information about the Microbio