EtO sterilization, a proven process leading to ethylene oxide autoclaves ever more innovative
With more than 50 years of existence, the ethylene oxide sterilization process for medical devices is one of the most used method in the word, thanks to its very good results and efficacy for thermos-sensitive products.
This process has had to evolve during all these years in order to offer a technology more and more efficient, safe and reliable. In addition, the introduction of innovative MD design and materials has led to develop new ways to sterilize, and to adapt the EO sterilization equipment to those new demanding products.
That’s the reason why RSD proposes tailor-made large sterilizers and turnkey EtO solutions with advanced technology including a high level of safety for its industrial autoclave design in order to meet any demanding requirement from the medical device manufacturers.
Our ETO sterilization autoclave
Our ethylene oxide autoclaves are specifically developed for Medical device industry, and are based on a state-of-the-art industrial autoclave design.
Below, the main characteristics of our EtO industrial sterilizer machine:
- High-efficiency equipment.
- Optimization of energy consumption and cycle time.
- Excellent EtO concentration and temperature uniformity.
- ATEX certified equipment (2014/34/UE).
- Well-proven components and materials to guarantee a long lifetime.
- ONYX+, our SCADA Control system programmed according to a strict HAZOP and SIL definition.
- 15-year warranty for pressure vessels.
- CE marked.
- Accurate and reliable instrumentation.
- Fulfilment of the stringent international regulations: 21 CFR Part11, EN1422, ISO11135... cGMPs guidelines are also followed.
- A reliable air purification system, especially designed for EtO treatment and meeting the stringent regulations for EO emissions like the TA-LUFT (<0.5mg/m³).
- A large range of options for our industrial autoclaves: automatic conveyor system, cooling jacket system, vertical sliding door, preconditioning and degassing cells, EtO monitoring system, parametric release, …
Our EtO solutions: Bespoke and turnkey
RSD offers bespoke and turnkey industrial projects, adapted to any customer’s requirements and needs at every project stage.
“Our aim is to offer the best technical and economical solutions to our customers, yielding a high level of safety, reliability and productivity.”
As our motto says, “the difference between a good job and an excellent job is the detail”. For this reason, we take care of every single detail of the projects we work on.
We qualify and validate our equipment thanks to a full package of quality protocols such as DQ, FDS, FAT, IQ and OQ, demonstrating that the project has been correctly designed and manufactured according to the customer’s requirements and applicable regulations.
Also, we are in charge of the installation and commissioning at the client site.
Our purpose is to offer complete solutions in which the innovation and safety are always present. Actually, they are incorporate from the beginning with the design, and during all the project phases.
Some relevant safety aspects of our industrial autoclave design:
- Reliable instruments to ensure a trustable control.
- ATEX certified equipment.
- In-depth risk analysis, based on several HAZOP and FMEA studies.
- Safety PLC with advanced components (SIL certified according IEC 61508).
- Well-proven and validated SCADA control system: ONYX.
It is obvious that a special know-how on the EtO sterilization is essential to develop this kind of complex equipment, especially to ensure the process safety thanks to proper operations.
RSD, expert in EtO sterilization process and EtO sterilization equipment manufacturing, takes care of your ethylene oxide sterilization projects from the beginning to their finalization.
We are a pharmaceutical autoclave manufacturer, exclusively dedicated to the ethylene oxide sterilization process.
Don’t hesitate to contact us in order to talk about your EtO sterilization project, or any other project related to EtO sterilization.