How we used our expertise to design, construct and fit-out a three-storey office, GMP cleanroom and laboratory for one of the UK’s trusted medicine supplier.
Quantum required a high tech principal contractor to design and build their new flagship facility in Burnopfield – they chose Merit!
- Cleanrooms were designed and constructed to ISO 5, 7 and 8.
- Merit provided full design for architectural, structural and M&E from RIBA stage 3.
- Design integrated all services with process systems and manufacturing requirements.
Merit was awarded the contract to design and build the new corporate HQ and GMP manufacturing areas for Quantum Pharma, in Burnopfield, County Durham.
Quantum Pharmaceuticals is a UK based manufacturer and supplier of unlicensed medicines and difficult to find medicines, which include tablets, creams, ointments, ear drops and capsules, to name a few. They are part of the Clinigen group; who are global leading experts in pharmaceuticals and biotech and are the market leaders in unlicensed medicines.
The building is a three-storey (2,200m²) facility comprising of GMP cleanroom suites, warehouse, first floor offices, meeting rooms and open plan areas, and a second-floor plant room. The facility is used for ‘Specials’ manufacturing of personalised medicine. The layout allowed for three Grade B manufacturing suites for Aseptic, Cytotoxic and Antibiotic products, separate products transfer and flow, Grade C and Grade D preparation areas and main gowning. Also within the building were GMP warehousing, product dispatch and a secure drug store.
Merit was issued with an outline concept design by the client, and completely re-designed the structure, the internal layouts and Mechanical and Electrical (M&E) services, as they were inadequate for the intent. Merit also highlighted some fundamental problems with the concept design, such as the building was raised 700mm and the plant room was reconfigured to maximise available warehouse space.
Merit provided revised layouts, personnel and material flow paths that were accepted by the MHRA, upon which the building and services were based on. Furthermore, Merit developed the Validation Master Plan for the project and carried out all of the validation to OQ (Operational Qualification). We also provided a detailed health and safety file for the client at the end of the works.
At Quantum, we used key suppliers for groundworks, steel, AHU, ductwork and flooring. This minimised the programme and quality risks for the project and also substantially reduced the procurement period.
The total project period of 42 weeks represented the full period of the contract including design and validation. We believe that our combined detailed knowledge of building, infrastructure, regulatory compliance and validation was of significant benefit to the client and this was demonstrated by delivery of a fast track project.