The ETO sterilization plant.
The ETO sterilization autoclave is of the automatic type, with parallelepiped body in AISI 304 stainless steel and carbon steel for reinforcements.
The external dimensions are 2450 (height) x 1600 (base) x 5500 (length).
The nominal internal volume is 12 m3.
The unit allows for the treatment of palletized groupings with a maximum dimension of 80x120x180h cm, guaranteeing the integrity of the lot under all phases of the process as well as with regard to internal logistics.
A sophisticated electronic system guarantees the facility of regulating timings, temperature, relative humidity as well as the pressure of the sterilizing mixture. Furthermore, the same system monitors the above parameters continuously during the cycle.
The autoclave conforms with:
- Directive PED 97/23/EEC for machines under pressure, CE0035 issued by TUV with test report No P28105226;
- Standard UNI EN 1422: 2009 regarding the Ethylene oxide sterilizer:
- Standard UNI CEI EN ISO 11135:2014;
- It carries registration No ISPESL 02/300475PD;
Gas mixture used: 10% Ethylene oxide + 90% CO2 (by weight).
The choice of a 10% mixture derives from the requirement to contain the risk of using Ethylene oxide as much as possible, in full compliance with environmental laws covering people and property.
The mixture is obtained in stainless steel cylinders.
The cylinder store is outside the establishment. The autoclave premises are adjacent to the establishment.
The ETO sterilization complies with the requirements, dispositions and indications contained in Royal Decree No 147/1927 on the storage and use of toxic gasses, and in circular 56/1983 of the Ministry of Health “Use of toxic gas Ethylene oxide”, as well as all the legislative requirements on safety.