Merit

TEVA

Expanding GMP Manufacturing Capacity.

south

Fast track project. Turnkey design and build. 90,000 man hours worked.

Merit was appointed Principal Contractor for the turnkey design and build of the new product warehousing, cold rooms, GMP Ophthalmic cleanrooms (Grade C) and plant areas; totalling 6,730m² footprint

  • Included GMP manufacturing areas and three floors of GMP cleanrooms (Grade C).
  • Merit self-performed M&E, process and cleanroom services.
  • Validation was taken through DQ, IQ and OQ.

TEVA is a leading international supplier of generic and specialist medicines. Based in Runcorn, the TEVA operation in the UK provides products to the NHS and specialist providers.

TEVA approached Merit to expand their UK manufacturing operations. Merit secured the role of Principal Contractor for the turnkey design and build of a new product warehouse, cold rooms, GMP Grade C cleanrooms and plant areas, totalling 6,730m².

The warehouse building was single storey with a 4,000m² footprint including loading docks and a full height GMP cold room. A new 2,700m² 3 storey building for GMP manufacturing was also created – including cleanrooms on the ground and first floors and plant areas on the second floor. Further areas of cleanroom were fitted out in the existing building and the whole contract finally integrated the new construction with the existing facility.

Initially, Merit was issued outline drawings equivalent to Stage 2 from which we produced a cost plan. Following on from this we worked with the client to develop the design to Stage 4 and at the same time fix the price to a lump sum. The structural engineers were novated to Merit from the client, the M&E design was developed in-house by Merit.

Our team worked with TEVA's QA department to utilise the client systems to develop a validation plan such that IQ, DQ & OQ protocols could be completed as part of Merit's scope of works. Merit integrated the validation and commissioning teams early on in the design processes to ensure there was a focus on the successful commissioning of the facility from the outset. In accordance with the validation requirements, Merit provided full commissioning and testing of the building with the manufacturing equipment in place and handover of all documentation to achieve OQ. Merit then provided comprehensive training for the building systems, as well as ongoing support as required.

Works were delivered in a complex, operational environment. No disruption to the daily activities and production was experienced throughout the project. All targets and budgets were met, despite a very aggressive schedule.