Due to the new technology and development of new materials in medical device companies, various products cannot be sterilised with the traditional methods, as per steam sterilisation. For many years, the ethylene oxide (ETO) sterilisation process has become one of the most used technologies for these kinds of products.
Its good results in terms of efficiency make this process an optimal sterilisation solution for all temperature-sensitive products such as syringes, catheters, sutures, latex, bandages and plastic articles.
RSD specialises in the ETO sterilisation process and turnkey pharmaceutical projects. Its great international experience and specific know-how make it a leader for ETO equipment.
ETO steriliser manufacturer
RSD designs, manufactures, installs and commissions ETO sterilisation equipment, fulfilling stringent international standards and good manufacturing practice (GMP) guidelines.
Through its knowledge and wide experience in this sterilisation process, the company offers optimal equipment and fulfils customer’s requirements. RSD understands the challenges that its customers’ have to face, as well as their need to increase productivity and to have a process that is both efficient and safe.
RSD’s ETO sterilisation equipment is designed for the pharmaceutical and medical device industries. The company proposes a modular design to divide the risk areas and reduce the probability of having a potentially explosive atmosphere. State-of-the-art materials and components are used to ensure an extended lifetime of the equipment.
Custom ETO sterilisers
RSD proposes industrial sterilisers with a minimum capacity of €4 pallets (10m3). Thanks to its flexible design based on several modules, the company can develop and manufacture tailor-made equipment for the purpose of satisfying the customer’s needs and demands. Furthermore, its ETO chambers are prepared to work either with an all-in-one cycle or with preconditioning and degassing cells.
The firm’s modular design comprises:
- Gas rooms
- Vaporiser skids
- Vacuum pump skids
- Control rooms
Chamber capacity ranges from €4 pallets (10m3) up to €32 pallets (80.6m3), with single-line or dual-line according to the chamber dimensions.
Turnkey ETO sterilisation solutions
To meet the customer’s expectations, RYD offers comprehensive ETO sterilisation plants based on reliable and safe solutions and adapted to industry demands. The company offers a large range of options. Its goal is to offer optimal solutions, based on advanced technology and innovation.
Some of RSD’s options include:
- Vertical sliding doors
- Parametric releases
- Modulating pneumatic valves
- Colling jacket systems
- Automatic loading and unloading systems
- ETO Monitoring systems
- Preconditioning and degassing cells
- Catalytic systems/scrubbers
- Pure steam generators
- Preventive maintenance
- Spare parts
RSD handles any project steps ranging from conceptual design to equipment commissioning, including manufacturing, programming, qualification and installation. It is a comprehensive, reliable and efficient ETO sterilisation project that is delivered and installed in the customer’s facility.
Safety is our priority
ETO sterilisation is not a process to be taken lightly. RSD is aware that ETO gas is dangerous (inflammable toxic, mutagenic and carcinogenic) and the company attaches importance to safety. Safety features include:
- The equipment is always based on an ATEX design
- Several safety instruments are installed such as flame arrestors, temperatures, pressures, level switches, and more than three redundant safeties for critical operations
- A qualified team that is Ism-ATEX certified by the notified body INERIS
- In-depth risk analysis based on several HAZOP and FMEA studies
- Safety PLC (Siemens/Allen Bradley) with advanced components, SIL certified as per IEC 61508
RSD control system
RSD has developed its own control system based on Supervisory Control and Data Acquisition (SCADA) technology, and programmed it based on the HAZOP analysis and SIL definition for each project. This reliable control system fulfils 21 CFR Part 11, and allows for example to create flexible recipes, to display synoptic, graphs, alarms.
The safety aspect has to be present in each development phases in order to ensure the total security of equipment and its process. We generate and execute a full quality protocols package such as DQ, FDS, FAT, IQ, OQ, including support for PQ. With those meticulous protocols, we give strong guarantees to the customer that his equipment has been designed and manufactured according to his requirements and the applicable regulations.
- Expert in EO sterilisation process, from design to validation
- Flexible design, based on several modules
- A single partner to manage all project aspects and to give support to any customer’s doubts and questions
- High-efficiency equipment, optimising energy consumption and cycle time
- Excellent EO concentration and temperature uniformity (+/1ºC)
- Use of Safety PLC, with safe modules (SIL 2 certified)
- Use of advanced 3D technology
- 100% of the chamber insulated
- High level of safety, ATEX-certified
- Use of state-of-the-art components and materials, to guarantee a long-term equipment viability
- SCADA technology for control system
- 21 CFR Part 11, ATEX 2014/34/UE, ISO11135 compliance
- RSD staff Ism-ATEX certified by a notified body
- Accurate instrumentation
- 15-year warranty on the chamber
RSD offers turnkey projects based on custom solutions to meet the customer’s needs and to ensure the safety of the personnel and the process, not forgetting the productivity and reliability.
The company believes that the difference between a good job and an excellent job is detail. For this reason, it carefully analyses each project, always considering the customer’s URS in order to give added value solutions.
Contact RSD to receive more details regarding our ETO comprehensive solutions.