First of all, it should be explained that the ethylene oxide (EO) is used for the sterilisation of temperature-sensitive materials, which are very common in medical devices such as syringes, catheters, latex gloves, multi-lumen tubing products, equipment with integrated-electronics and some plastic tubes.
This sterilisation process enables low-temperature sterilisation with an optimum result (without deterioration and damaging of the products to sterilise).
For this reason, this sterilisation process is often requested from many pharmaceutical industries and medical devices manufacturers. Many of these look for turnkey EO sterilisation solutions for their facilities, fulfilling all their requirements and needs.
Medical devices and pharmaceutical industries are looking for turnkey sterilisation solutions
The companies that have to use EO gaz in order to sterilise great quantity (in other words, several pallets), tend to look for full turnkey and comprehensive solutions to install in their facilities.
The EO sterilisation projects are usually major and complex, therefore they should not be taken lightly. Moreover, due to the dangerousness of the EO gas, the safety should be omnipresent in every project.
What does turnkey EO sterilisation project consist of?
It depends on the requirements and necessities of the clients, but generally, a turnkey EO sterilisation solution is composed of several ancillary modules, in addition to the steriliser.
Turnkey EO sterilisation solutions proposed by RSD company
RSD specialises in EO sterilisation and it offers turnkey projects, including:
- Sterilisation chambers – RSD proposes a wide range of standard chambers both under and over-pressure, and can be customised according to customer requirements. The capacity of the company’s autoclaves goes from €4 pallets (10m³ approximately) up to €32 pallets (80,6m³ approximately). They have high technical specifications as standard such as automated doors, safety programmable logic controllers (PLC), high accuracy for instruments, high-quality stainless steel and an efficient jacket system. Many other options are available to meet the client requirements, including all-in-one process, parametrical release, automatic loading and unloading system and jacket cooling systems
- Vacuum pump skids – Liquid ring pumps is the safest process for vacuum, and the best choice to reduce maintenance operations
- Pre-conditioning and degassing cells allow for a reduction of cycle time. The EO process requires a conditioning phase where steam is injected to stimulate the product microorganism’s growth. This phase could be done either inside the chamber or in a preconditioning cell to save time. On the other hand, a degassing phase is necessary in order to take out the EO residual particles from the products that are sterilised. This phase also could be done either inside the chamber or in a degassing cell to save time
- A vaporiser skid is installed either in the chamber or in the gas room. It allows the correct vaporization of EO gas thanks to several instruments installed, to ensure a maximum safety
- An air recirculation system is placed on the top of the chamber. It allows to have an excellent EO concentration and temperature distribution (+/-1ºC)
- A steam generator is necessary to humidify the load in the chamber or preconditioning cell. Then two designs can be proposed: Electrical type or steam/steam heated
- An air purification system allows for the elimination of high and low concentration of EO in the chamber and degassing cells. Catalytic systems or scrubbers can be offered
- The gas room should be separated from the chamber room. A special design allows the automatic changeover of the EO containers, which are placed on weight scales
Any equipment and ancillary modules are designed, manufactured and installed considering ATEX classification, good manufacturing practice (GMP) guidelines, Safety Integrity Level (SIL) compliance, and any current standard.
What does RSD take care of?
RSD takes care of the whole project, from its beginning until its end.
The company designs, manufactures, qualifies, installs and commissions all the equipment and modules of any EO sterilisation projects. It works with some of the best-advanced technologies, and it uses state-of-the-art components to offer comprehensive, safe and reliable EO solutions.
RSD’s team is composed of experts that specialise in each project phase (electrical, mechanical engineering, manufacturing, programming and validation, and commissioning). All of the members of this team also have the Ism-ATEX certificate, delivered by the notified body INERIS.
In addition, RSD’s EO sterilisation solutions are provided with an accurate control system that has been developed by ourselves, based on SCADA technology, and programmed according to our strict HAZOP analysis and SIL definition for each project. Software validation is also performed, which ensures the process and staff safety.
To have a sterilisation process running with optimum conditions, we offer a full package of quality protocols such as design qualification (DQ), FDS, FAT, installation qualification (IQ), operational qualification (OQ) and support for performance qualification (PQ). RSD generates and executes all these protocols during each phase of the projects. In that way, the company ensures that the client is buying a safe and reliable unit.
To work with us is to work with a trusted and unique partner during the whole project.
We invite you to visit our website, to look at our equipment and services. Don´t hesitate to contact us for further information.