Ethylene oxide sterilisation autoclaves operating under atmospheric pressure are designed and manufactured to optimise the combined use of essential sterilisation factors, such as the concentration of the EO gas mixture, the material exposure time, the temperature and the relative humidity in the chamber. These vacuum machines operate at atmospheric pressure levels (not suitable for pressurised operation) and are not required to comply with PED.
To optimise the process, we equip our machines with cycle handling equipment and control software that ensure total autoclave automation and monitoring, reading and logging of all data.
Each chamber incorporates an automatic load handling system, an essential function that ensures the sterilisation of entire pallets without having to handle them and with complete operator safety.
Technical Details
Door with manual or motorised opening;
Pneumatic release and securement system;
Internal pallet handling system;
Electrical panels;
Supervision and control software (PLC and SCADA);
Insulation layer;
Parallelepiped shape;
Fully customisable volume and dimensions.
Applicable standards
The equipment complies with European standards UNI EN ISO 11135:2014 – Ethylene oxide: Requirements for the development, validation and routine control of a sterilisation process for medical devices; 2014/35/EC (Low Voltage); 2014/30/EC (EMC); 2006/42/EC (MD).
They do not need to be assessed for compliance with the 2014/68/EU PED Directive because they are non-pressurised vessels.