An important step in the process of constant improvement that is at
the base of our company’s policy is represented by our in house
ethylene oxide sterilization of the company’s production and
third party production, activated in 2005 and approved according to
the EN 550 and ISO 11135 norms.
The sterilization autoclave that has a PED (Dir. 97/23/CE) and an
ISPESL certificate, is of the prismatic 12 mc type that is completely
automatic and uses a sterilizing gas mix made up 10% Ethylene Oxide
and 90% Carbon dioxide.
The ETO treatment plant is built according to law regulations in the
current norms concerning security matters and is equipped with modern
warning systems that control neutralization, breakdown of toxic gas
and fire extinguishers for the protection of the staff members.
The sterilization cycle is predefined on a computer that controls
the whole implant. The check up of the process is done and documented
at every cycle with the verification of the printed parameters on
the registration log and further comparison with chemical and biological
indicators.
The degassing of the sterile lots comes about in a quarantined warehouse,
allowing the residual ETO on the product to reach the security levels
according to the current norms.
The management, the control and the responsibility of the running
of the implant, along with the handling and use of the gases is entrusted
to competent and skilled staff that has been trained in accordance
to the specific laws (R.D. 9 January 1927, n.147).
Micro biological tests
ADRIA.MED. is able to provide its Customers complete
assistance in product sterilization thanks to its in house micro biological
analysis laboratory, therefore able to test biological process indicators
in order to guarantee the sterility of the devices and process efficiency.
The lab is controlled by the company’s quality system which
is conducted by qualified staff and it also carries out internal physical
and technological tests.
