How do you support clients with FDA and MHRA regulatory requirements?
As experts in cleanroom and laboratory constructions, we understand the regulatory standards and requirements that have to be met. Our processes are aligned to meet such standards – in Wockhardt’s case this was FDA and MHRA.
- 38 week programme from design to handover.
- We devised a number of value engineering solutions including the reuse of existing building controls, HVAC, steam system and chillers and the reuse of existing equipment.
- Merit successfully procured and integrated the clients’ process equipment into the overall project.
Merit was awarded the works as Principal Contractor for the turnkey design and build refurbishment of the compression suites within the existing Wockhardt Building 4 and 5 facilities.
Wockhardt is one of the largest generic pharmaceutical companies in the UK and specialise in the manufacture and supply of generic medicines, with a growing protfolio of over 350 product lines. They work as a leading supplier to the hospital and retail pharmacy sectors, and manufacture their own label products for supermarkets, multiple retailers, pharmacy chains and wholesale customers.
The works took place at Wockhardt’s Wrexham based head office – home of their FDA and MHRA approved sterile injectable manufacturing facility, which has been established for over 60 years. The scope of works included the refurbishment of the existing facility including the remodelling of internal space of 1,500m² to provide QC laboratory, analytical laboratory, associated offices, circulation area and entrance area.
Merit’s scope of works included modifications to the existing build to create a new cleanroom area, ground works, civils, M&E and process services, process systems and internal architecture. Both labs were constructed on a raised access floor with services running below the floor providing special gases, power and water to the new lab benching. The labs were unclassified but still required to meet GMP standards. Merit was responsible for the validation of the labs.
The client made a number of changes to the scope including the additional of a new area of works on the ground floor. Merit worked with the client to amend the design and determine the cost of the changes. Merit also undertook all recalculations associated with the changes and installed further DB boards to deal with additional loads. We also installed specialist gas systems including acetylene, helium and nitrogen which were brought in at the rear elevation of the building from purpose built gas cages.