Tel. +39 039 2060472 -

ETO Sterilization

ETo Sterilization according to EN ISO 11135.

The full sterilization process with preconditioning, sterilization and degasing of the medical devices are optimized to guarantee the conformity with EN norm (included ISO 10993 on EtO residual).
Medical devices will be checked in the incoming control to verify the conformity with validation.

The process is built on 3 steps:

First step is to provide optimum condition of humidity and temperature to medical devices for sterilization. The preconditioning chamber has the same dimension with the sterilization chamber.
At the end of preconditioning step, a fast load is provided to the sterilization chamber to maintain the same condition of the material for sterilization process.

Sterilization process
The sterilization process is performed in big autoclaves (55 mc) with ethylene oxide. The validation of the process is according to EN ISO 11135 and the process is customized on products need.
After the sterilization step an air flushing phase eliminate the sterilization gas before opening the autoclaves.

After sterilization process the material is loaded in degasing boxes to eliminate the EtO residual and guarantee the conformity on medical devices with EN ISO 10993.

Sterilizzazione ETO