RSD, an expert in the ethylene oxide (EtO) sterilisation process, offers EtO sterilisers of high capacity (from four to 32 Euro pallets) developed specifically for the pharmaceutical and medical device (MD) industries.
Our EtO sterilisation equipment
We offer equipment with a high performance level based on safety and high quality, fulfilling the strictest sector regulations, including the current good manufacturing practice (cGMP) guidelines set up by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), the pressure vessel (2014/68/UE) and explosion risks (ATEX directive, 2014/34/UE).
Our EtO sterilisation equipment is designed and manufactured according to the customer’s requirements, in a stringent development process focused on innovative solutions.
Our EtO chambers are characterised by :
- High-efficiency equipment optimising energy consumption and cycle time
- Excellent EtO concentration and temperature uniformity (+/-1ºC)
- Use of a safety PLC (EN 61508) with safety modules (SIL 2 certified)
- The chamber is fully insulated
- ATEX-certified chamber providing a high level of safety
- Efficient vacuum pumps based on liquid ring technology
- Premium materials and components are used to guarantee long-term equipment viability
- Using ONYX, a well-proven technology for the SCADA control system
- Compliance with 21 CFR Part11, ATEX 2014/34/UE, ISO11135 and EN1422 among other regulations
- Accurate instrumentation
- 15-year warranty for the EtO chamber and any pressure vessel
Your comprehensive EtO sterilisation facility supplier
RSD offers complete services for EtO sterilisation projects. We can take care of any aspect of the project, from the feasibility study to the equipment commissioning.
Working with us on the design of your EtO sterilisation facility, you will have a trusted partner at your side that will provide you with customised services based on a wide experience.
We also specialise in providing turnkey EtO sterilisation projects that can be fully bespoke. The following equipment can be proposed to you for a ready-to-use facility:
- EtO chamber
- Vacuum pump skid
- Gas room
- Steam generator
- Vapouriser skid
- Pre-conditioning and degassing cells
- Air purification system
- EtO monitoring system (LEL, PPM)
All the equipment is designed, manufactured, controlled, qualified and commissioned by RSD.
Please also note that we propose several options, including but not limited to:
- Modulating pneumatic valves
- Automatic conveyor system
- Backvent
- Cooling jacket system
- Parametric release
- Preventive maintenance
We commit ourselves to provide turnkey solutions fully adapted to our customer’s needs, giving a high level of safety, reliability and productivity.
Thanks to the combination of our extensive experience and our specific EtO know-how, we provide optimal solutions for the most demanding customers worldwide.
Have a look at our EtO sterilisation equipment catalogue and contact us for further information.