Référence
University Research Facility
Our client specialise in stem cell research, with a Regenerative Medicine centre based at a UK University dedicated to the study and development of new regenerative treatments for human diseases. Their facility contains laboratory and support space, incubator units and a clinical translation unit containing high grade GMP cleanrooms, which facilitate the receipt of embryos from IVF clinics.
B, C & D
Cleanroom Grade
HVAC
systems
MHRA
compliant
The Regenerative Medicine Centre is the first large-scale, purpose-built facility of its kind in the UK and was the first laboratory building in Scotland to receive a BREEAM “Excellent” rating. Bouygues Energies & Services were appointed as the preferred contractor for the design, construction, commissioning and validation of all GMP areas, associated services and clean utility systems. The client required:
- Optimisation of the proposed design
- Construction of the GMP areas and installation of all associated specialist equipment including autoclaves, isolators, MBSCs, services and clean utilities
- Commissioning of HVAC Systems and associated utilities serving the GMP areas
- Validation of the clean rooms, services and utilities within the GMP areas
- Validation of equipment within the GMP areas
- Project management of the overall validation programme
Our Solution
Bouygues Energies & Services’ turnkey solution encompassed the design, construction, fit-out, commissioning and validation of the client’s high grade cleanroom, including EU GMP Grade B, C and D areas, with local Grade A environment in isolators and MBSCs.
The facility required a high level of services through mechanical and electrical plant, and as such the plant was located on a dedicated plant floor, sandwiched between the two research floors. All equipment and services were designed in order to facilitate access for operability and maintenance, without risking any compromise to the control measures required in GMP environments.
The internal fit-out and integration included the installation of autoclaves, process gas systems, and environmental monitoring system in line with current regulatory requirements, cryostorage facilities, and a walk-in cold room.
Bouygues Energies & Services in-house comprehensive regulatory compliance and validation support was provided to the client, including arranging a design review meeting with the MHRA. We provided a full validation service which included the generation of a Validation Master Plan and final Validation Summary Report. We were also awarded the Facilities Management contract for the planned maintenance and revalidation of the GMP areas of the facility.
Client Benefits
Single Point of Accountability
Providing detailed design, architectural, construction, procurement, installation, process engineering, mechanical & electrical services, commissioning and validation to offer seamless engineering solutions to the challenges facing our client.
Assurance of Compliance
A fully validated facility with successful HTA and MHRA inspections.
Value for Money
Bouygues Energies & Services’ holistic approach means that sub-contracting and external sourcing costs were minimised, as we took ownership of budget and cost overruns. It also meant we were able to deliver the project within a smaller time frame than competitors, ensuring the project was completed to time and economic constraints.
Optimised Usability
Access for operability was a full incorporated aspect of the design, ensuring optimal usability for the client.
Knowledge and Experience
Bouygues Energies & Services had the in depth knowledge of the facility to be able to provide a fully compliant Facilities Management package which included the requirements for facility revalidation.
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