Ethylene Oxide Sterilization: Well-Proven Process with Innovative Equipment - Pharmaceutical Technology
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Ethylene Oxide Sterilization: Well-Proven Process with Innovative Equipment

With more 50 years of existence, the ethylene oxide sterilization process still has huge importance in the industry, as it is used for more than 50% of the medical devices in the world.

However, some recent environmental issues in the US during 2019 pushed the FDA to find alternatives or improvements to this process. It is not the first time that the EO process is boxed into a corner, as it is the same deal for many years now. Its efficacy and simplicity for the sterilization of sensitive products make a big challenge to find another option.

Some ETO equipment manufacturers are working to improve this technology, first to meet more and more specific client’s requirements, but also to ensure a reliable and safe process with added value. The ETO sterilization process and equipment are constantly evolving, and it is still considered as one of the best solutions for the sterilization of a large number of medical devices.

RSD company proposes an advanced technology to meet any demanding requirement from the MD manufacturers.

The ETO sterilization equipment by RSD, a state-of-the-art

Our ETO sterilizer, as well as all the ancillary equipment necessary to have a complete ETO sterilization installation, are designed and manufactured exclusively for Medical devices and pharmaceutical industries, integrating advanced technologies and high-quality materials and components.

The main characteristics of our ethylene oxide sterilizers are:

  • High-efficiency equipment, optimizing energy consumption and cycle time.
  • Excellent ETO concentration and temperature uniformity.
  • ATEX certified equipment (Explosion Risk, 2014/34/UE) for optimum safety.
  • Well-proven components and materials, offering reliability and high quality, to guarantee a long lifetime and to make maintenance operations easier.
  • Our SCADA Control system ONYX+, programmed according to a strict HAZOP and SIL definition, for every single project.
  • 15-year warranty for pressure vessels like chamber, doors, vaporizer.
  • CE marked in agreement with European normative.
  • Accurate and reliable instrumentation.
  • Equipment that fulfils stringent international normative and regulations like 21 CFR Part11, EN1422, ISO11135… cGMPs guidelines are also followed.
  • Integration of a reliable air purification system, specially designed for ETO treatment. Such a technology reaches the stringiest international regulation for EO emissions, the TA-LUFT (<0.5mg/m³).
  • A large range of options: Automatic conveyor system, cooling jacket system, Vertical sliding door, preconditioning and degassing cells, EtO monitoring system, Parametric release.

Bespoke and turnkey ETO sterilization installation

RSD offers to Medical device and pharmaceutical industries bespoke and turnkey projects, adapted to customer’s requirements and needs.

Our aim is to offer the best technical and economical solutions to our customers, yielding a high level of safety, reliability and productivity.

We offer totally qualified equipment with a full package for quality protocols such as DQ, FDS, FAT, IQ, OQ and support for PQ. These protocols prove that the equipment has been designed and manufactured according to the customer requirements and applicable regulations.

In addition, we take care of the installation and commissioning of our ETO sterilization equipment.

The innovation key player of safety

The innovation has an important role in the design of equipment and should be considered as well for the process safety. The know-how in the ETO sterilization process is essential and primordial to guarantee the safety and the correct process operations. In other words, innovation has to go hand in hand with good process control to ensure a high level of safety.

Some relevant safety aspects of RSD design:

  • Reliable instruments to prevent hazardous situations.
  • Certified ATEX equipment.
  • In-depth risk analysis, based on several HAZOP and FMEA.
  • Safety PLC with advanced components (SIL –certified) limiting failure probabilities.
  • Well-proven and validated SCADA control system.

As ETO sterilization equipment manufacturer and expert, we offer comprehensive ETO sterilization solutions with advanced technology, based on a high level of safety.
Being aware of the delicate situation that the Ethylene Oxide is constantly facing, we aim to propose adapted solutions and top-level in terms of safety.

For more information, please fill out the enquiry form attached to this page.

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