safe and compliant chemical sterilisation capacity
To meet the client’s requirements, Equans Sci-Tech* defined, designed and delivered a modern, compliant sterilisation facility to streamline operations and support the future growth of our client.safe and compliant chemical sterilisation capacity
To meet the client’s requirements, Equans Sci-Tech* defined, designed and delivered a modern, compliant sterilisation facility to streamline operations and support the future growth of our client.
Key figures
Key figures
Overview
Our client, a global leader in medical devices for aortic and peripheral vascular disease, engaged Equans Sci-Tech to scale up and modernise their facility. The client sought a new state-of-the-art Ethylene Oxide (EtO) sterilisation suite and upgraded cleanrooms. The facility is enhancing capacity and operational space while ensuring complete compliance and uninterrupted production.
Technical mastery
We applied our in-house expertise to develop a strategic master plan that seamlessly integrated the new manufacturing facility and warehouse with the existing building. We defined the optimal process, and people flows and delivered the concept through to detailed design. A standout feature is the central atrium - a unifying space that connects the entrance, production areas, and offices under one roof.
We designed and delivered a modern sterilisation facility with key support areas including a control room, preparation room, aeration area, QC lab, and final packing zone. The project modernises operations and future-proofs capacity, while upgrading infrastructure within a live facility. It was carefully managed to minimise disruption and ensure safe, compliant delivery.
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ATEX-compliant project with M&E systems and process equipment.
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Safety features: emergency power, gas dispersion modelling, gas detection, and alarm systems, with the design reviewed through a comprehensive Hazard and Operability (HAZOP) and Layers of Protection Analysis (LOPA) safety studies.
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Validated equipment and environment for biological indicator preparation, final packaging, and label verification.
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Full commissioning & validation delivered (URS, FATs/SATs, IQ, OQ) in alignment with client quality framework.
Benefits
The sterilisation facility provides a modern, high-capacity suite that meets strict safety and compliance standards. With three fully validated sterilisers and integrated HVAC and abatement systems, the facility enhances both operational resilience and environmental performance.
Advanced control and monitoring systems ensure full compliance with 21 CFR Part 11, GAMP 5, and SEPA regulations. Designed and delivered for scalability, the facility was upgraded to the latest regulations.
Key results:
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EtO emissions <1ppm through advanced abatement systems.
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Validated for 6+ product types across multiple cycle profiles.
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Automated SCADA system with full traceability and manufacturing execution system (MES) integration.
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Compliant with ISO 11135:2014 ethylene oxide sterilisation process for medical devices and ATEX regulations.
Future-ready infrastructure completed with zero incidents during the COVID-19 pandemic, despite the challenges posed by a demanding timeline.
Explore our full range of capabilities.
At Equans Sci-Tech, we specialise in mission-critical environments where precision is non-negotiable. Whether you are launching a greenfield development or repurposing existing building services, our fully integrated team provides a single point of contact to Define, Design, and Deliver your most complex requirements.
* Formerly known as Bouygues Energies & Services
Ready to discuss your project?
From initial feasibility to high-precision delivery, we provide the end-to-end expertise and technical leadership you need to move forward with confidence. Get in touch to discuss how we can bring your next mission-critical project to life.Ready to discuss your project?
From initial feasibility to high-precision delivery, we provide the end-to-end expertise and technical leadership you need to move forward with confidence. Get in touch to discuss how we can bring your next mission-critical project to life.