Ethylene Oxide Sterilization Equipment
Turnkey project for ethylene oxide sterilization
We design, manufacture, control and qualify Ethylene Oxide Sterilizers (EO/ETO) for the sterilization of thermo sensitive products (sensitive to heat and humidity) like syringes, catheters, dialysis cartridges, plastic dressings, sutures, etc.
We are Ethylene oxide sterilizers manufacturer, the perfect method for medical device sterilization. Apart from designing and manufacturing the sterilizer, we also provide all the ancillary equipment in order to offer a complete sterilization unit by ethylene oxide process.
Ethyle Oxide Sterilization Chambers - EO machine
Our design is modular type and gives the main advantage to divide the risk area in order to reduce the probability of having a potential explosive atmosphere. Those projects are customizable as we offer a very flexible design, according to the client requirements. Our chambers are prepared to work either with All in One cycle, or with preconditioning and degassing cells. We also propose all the ancillary equipment for turnkey projects.
Our standard design for autoclave machines goes from 4 Euro pallets up to 32 Euro pallets model, but are not limited and the dimensions and design can be adjusted according to the final user needs.
RSD® designs for ETO sterilization plant:
For their turnkey projects, we use a modular design, in order to suit to the customer ATEX classification:
- Gas room
- Vacuum pump skid
- Vaporizer skid
- Preconditioning room
- Degassing room
- Pure steam generator
- Air purification system (Catalytic abatement or Scrubber)
- Control room
ETO sterilizer specifications
- Flexible design, based on several modules,
- High efficiency, optimizing energy consumption and cycle time,
- Excellent EO concentration and temperature uniformity (+/1ºC),
- Use of 100% EO (+N2) as well as 90/10 mixture, to limit the chamber internal pressure (<+0,5b),
- High safety level, delivering ATEX certificate (zone 1 / zone 2),
- Use of well known brands for all the components,
- GMP designs and comply with the most stringent European standards,
- Compliant with 21 CFR Part 11, ATEX 2014/34/UE, ISO11135, and others,
- 15-year warranty on the chamber,
Safety of our EO sterilization equipment
For we, safety is a priority for personal as well as for the sterilisation equipment. For that, the PLC is composed of special safety modules, and is programmed together with the SCADA according the HAZOP of each project. In addition, several safeties are taken into account during the design, like for instance: 3 redundant safeties as minimum for any critical function (PL/SIL), automatic calculation of the inflammable diagram, use of flame arrestors, etc.
Our control system "The ONYX control system"
We have developed our own high quality control system "The ONYX control system", specially designed for ethylene oxide sterilization equipment. Its goal is to ensure a reliable, safe and efficient sterilization process. It is a control system based on SCADA technology that adapts to the needs of the customer and offers many advantages. Learn more about the ONYX control system for EtO sterilization equipment.
ETO sterilizer and ETO plant options
(non-exhaustive list of available options)
- Vertical doors,
- Parametrical release,
- Modulating pneumatic valves,
- Cooling system for jacket,
- Pure steam generator,
- Automatic loading and unloading system,
- Monitoring system (LEL / PPM),
- Preconditioning cells,
- Degassing cells,
- Catalytic system / Scrubber,
- Spare parts,
- Preventive maintenance,
Each autoclave is qualified according to a qualification plan which includes the generation and performance of quality protocols, which are: FDS, DQ, FAT, IQ and OQ. Once the FAT is signed, the equipment is mechanically and electrically installed at customer site. Then, the last quality protocols are executed.
Our EtO sterilization equipment and turnkey projects
Through the following pictures, find out our EtO sterilizers and any ancillary equipment for EtO sterilization turnkey projects.