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Ethylene Oxide Sterilizers - ETO Sterilizers

Ethylene Oxide Sterilizers - ETO Sterilizers

Ethylene Oxide Sterilizers - ETO Sterilizers

Product catalog summary
Introduction: RSD is a Spanish company specializing in ethylene oxide (ETO) sterilization solutions for medical devices. They offer comprehensive services from design to installation, ensuring high safety, reliability, and productivity.
Specifications: RSD designs and manufactures ETO sterilizers that comply with cGMPs, EMEA, FDA, and ATEX standards. Their equipment features advanced technology, including Safety PLCs, 3D technology, and SCADA control systems. The chambers are fully insulated and offer excellent ETO concentration and temperature uniformity.
Design and Customization: RSD provides modular designs to suit customer requirements, including options for preconditioning and degassing cells. The chambers can be customized in size and feature automated doors and high-quality materials.
Safety and Quality: Safety is a priority, with ATEX-certified designs and extensive risk analysis. RSD offers a full package of quality protocols (DQ, FDS, FAT, IQ, OQ, PQ) to ensure compliance with regulations.
Control System: The control system is based on SCADA technology, fulfilling GAMP 5 and 21 CFR Part 11 standards. It includes features like flexible recipes, interlock management, and user-level access.
Product Range: RSD offers a range of ETO sterilization models with varying chamber sizes and capacities, customizable to customer needs.
Conclusion: RSD provides turnkey ETO sterilization solutions with a focus on safety, quality, and customer-specific customization, supported by a qualified team and advanced technology.
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Catalog excerpts

Ethylene Oxide Sterilizers - ETO Sterilizers-1

STERILIZATION SOLUTIONS Your partner for comprehensive ETO Sterilization solutions.

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Ethylene Oxide Sterilizers - ETO Sterilizers-2

WHY WORK WITH RSD: Expert in ETO sterilization process, from design to validation. Flexible design, based on several modules. High-efficiency equipment, optimizing energy consumption and cycle time. Excellent ETO concentration and temperature uniformity (+/1°C). 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 long-term equipment viability. Use of well proven technology for the SCADA control system. Compliant with 21 CFR Part...

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Our turnkey ETO sterilization facilities, a complete solution. We deliver full sterilization units with their ancillary modules. The RSD design is focused on safety; therefore, we propose a modular design in order to divide the potential explosion risks and to suit the plant layout of our customers. Our design, manufacturing and qualification are in accordance with GMP standards, ATEX zone classification and all applicable regulations. These projects are customizable as we offer a very flexible design that is based on the customer’s requirements. Our chambers are suitable for working either with...

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MODULAR DESIGN: Chamber: A wide range of pressure chambers is available and can be customized. Automated doors are offered, and high quality stainless steel is used for the chamber, the door and the piping. The jacket system is highly efficient, allowing fast heating and cooling time. An all-in-one process can be chosen, and accurate and reliable instrumentation ensures safe cycles. Air recirculation: On the top of the chamber, an air recirculation system with a high rating ensures excellent ETO concentration and temperature distribution (+/-1ºC) to make the validation easier. The stable process...

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Safety is not an option, it is a priority. FOR RSD, SAFETY FOR PROCESS AND PERSONNEL IS A PRIORITY. FOR THIS REASON, RSD PROPOSES: One of the safest equipment on the market, always based on an ATEX design. Several safety instruments like flame arrestors and other instruments to prevent hazardous situations. A qualified team that is Ism-ATEX certified by the INERIS notified body. In-depth risk analysis based on several HAZOP and FMEA. Safety PLC (Siemens/Allen Bradley) with advanced components, SIL-certified as per IEC 61508. CONTROL SYSTEM: RSD has developed its own control system, based on SCADA...

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* Dimensions could be adjusted according to customer's requirements. RSD Engineering Solutions, S.L. C/ Horts d’en Mateu, 26 - 08450 Llinars del Valles (Barcelona) - SPAIN Phone: +34 938 55 35 55 [email protected] | www.rsd-engineering.com

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.