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Ethylene Oxide (EO) Sterilization Consulting Services
RSD Engineering Solutions SL provides expert consulting services in ethylene oxide sterilization, leveraging extensive experience with global companies in navigating stringent international standards. The company holds Ism-ATEX level 1 and 2 certificates for the design and maintenance of installations in explosive environments, accredited by INERIS, a French notified body. RSD's consulting services are targeted at pharmaceutical companies operating in GMP environments, focusing on delivering optimized process solutions. With a proven track record, they have successfully partnered with industry leaders like Bbraun, Merck Millipore, and Becton Dickinson. RSD is committed to offering efficient, confidential advisory services, aiming to help clients achieve excellence in EO sterilization processes, equipment design, and pharmaceutical project execution.
- EO Cycle optimization;
- Cycle validation for ethylene Oxide process (ETO);
- Maintenance of sterilizers / sterilization units;
- Installation and verification services;
- Protocol redaction and performance (FDS, DQ, FAT, IQ, OQ and PQ);
- EO sterilization plant sizing, according to customer requirements;
- Utility calculations (N2/CO2, EO, chilled water, steam,…), needed for the running of a EO sterilization installation;
- Safety audit to fulfill the ATEX 2014/34/UE directive;
- Existing installation upgrade to be conformed to ATEX directive;
- Parametrical release implantation on existing sterilizers;
- Flammability calculations;
- ROI calculations for a sterilization project investment;
- Expertise and advices for technological, strategic and operative problems;