Improving healthcare for all

SOLSTEO, ethylene oxide sterilization for medical devices

The French start-up SME designs, manufactures, installs, and maintains ethylene oxide (EO) sterilization equipment

9 Nov 2021

Active since 2000 in ethylene oxide sterilization, SOLSTEO targets medical device manufacturers and EO sterilization contractors, helping them to provide reliable, secure, and innovative solutions. The French company manufactures custom sterilizers from 1 m3 to 150 m3, i.e., 1 to 32 pallets, and gas treatment systems that meet customer requirements and current standards. 

EO sterilization is the final step in the medical device manufacturing process: the boxes of products are placed on pallets which are themselves exposed to the sterilizing gas in the sterilizer. Ethylene oxide, injected in gaseous form into the tank, penetrates to the core of the products through the packaging, thus sterilizing the entire pallet in a few hours. 

SOLSTEO supports its customers from design to maintenance. Under the organizational model used by SOLSTEO, design and engineering activities are centralized in Paris, and bespoke metal fabrication is done in Angers (France). This is a 100% French manufacturing business model.

Once manufacturing is complete, the equipment is fully assembled and tested in the factory, in a process that reproduces how it will eventually be installed at the customer’s site. The company is then responsible for installing and certifying the equipment in the customer’s factory, providing a 15-year manufacturer’s warranty.

SOLSTEO’S NUMBER 1 PRIORITY: SAFETY

Safety is paramount to SOLSTEO. The company has extensive knowledge of the ATEX European Directive (relating to Explosive Atmospheres) and participates in the ISO working groups on the ISO 11135 standard.

“The properties of ethylene oxide are perfectly suited to meet the standardization requirements for sterilizing medical devices. But let’s not forget that EO is also a dangerous gas, because of its flammability and its toxicity to humans, hence the need to strictly control exposure to it,” explains Pierre Bouché, co-founder of SOLSTEO.

New in 2022: SOLSTEO is preparing to market an infra-red gas analyzer capable of measuring the concentration of EO in sterilizers in real time. The result of R&D work carried out with VAISALA, a major European manufacturer of measuring instruments, this new analyzer will benefit from ATEX zone 0 certification issued directly by the manufacturing plant. It will thus be the first ATEX zone 0 infra-red analyzer available on the market! 

This innovation will enhance machine safety and improve the reliability of the reproducibility of the sterilization process.

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