Co-ordinated solution for pioneering biopharma plant

WH Partnership’s recently completed facility for Oxford BioMedica called for innovative and co-ordinated solutions to meet both the client’s needs and the regulator’s GMP requirements

Oxford BioMedica’s new cleanroom is used in the production of gene-based medicines

WH Partnership (WHP), one of the UK’s leading providers of integrated process and cleanrooms, designed and built Oxford BioMedica’s (OXB) new cleanroom production facility in Yarnton, Oxford. The plant, which manufactures unique gene-based medicines for its own clinical programmes and for some of the world’s largest pharmaceutical companies, develops pioneering products for diseases that currently have no treatment.

Constructed to comply with stringent UK Good Manufacturing Practice (GMP) regulations, the 560m2 of additional cleanroom space took less than a year from concept to completion and creates extra capacity for OXB and its existing and potential customers. The facility was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on first application to manufacture bulk drug material for Investigational Medicinal Products (IMPs). Crucially, this meant that OXB could begin manufacturing as soon as possible.

Overcoming challenges

OXB’s project managers Thomas & Adamson appointed WHP at Stage C design on a design and build contract. While there was an existing User Requirement Specification (URS) and outline design, WHP worked closely with OXB to co-ordinate fully hooked-up cleanroom structural and services elements and develop the best solution.

WHP’s specialist knowledge and expertise were well used during the complex installation of the ductwork system and in commissioning multiple pressure regimes

The WHP team faced several challenges as the project progressed. There were nine separate air handling units in the plan, each of which required its own ventilation system. This meant that WHP’s specialist knowledge and expertise were well used during the complex installation of the ductwork system and in commissioning multiple pressure regimes.

During the build it was necessary to bring in a new power supply. This required a detailed co-ordination exercise to ensure the cables could be incorporated into the proposed new structure. The walls posed a particular design challenge. HEPA filtration was required at low level in the cleanroom areas, in addition to mezzanine columns and all of the services, including utility gases. The wall structure and specification were re-designed and a double wall panel system with internal service voids installed. WHP used its design expertise, alongside in-house CAD and modelling to resolve this tricky issue.

Inside-out approach

WHP recognises that the integration of operational plant and equipment into a cleanroom is key to meeting client expectations. It adopts an ‘inside out’ approach, starting with the manufacturing or process needs, rather than the constraints of the building. Different concept ideas are then presented so that the implications for time, money and the impacts on facility operation can be fully considered before deciding on the most appropriate solution. In OXB’s case, the facility was to be completed in three phases, so this needed to be considered carefully in the initial design. The need to future-proof the facility for future scale-up in production processes and volumes was also of paramount importance.

Process-led knowledge

WHP’s process-led knowledge was invaluable in constructing a first-class facility that was completed on time and to budget as well as meeting the expectations of the regulatory bodies. Its core team of qualified and experienced staff allowed for maximum flexibility in responding to the needs of OXB.

Using a buildings information management (BIM) system to illustrate and manipulate designs in progress enabled real-time engineering

Its in-house engineering expertise was central to the project team’s ability to respond to the significant changes in specification and programme. Using a buildings information management (BIM) system to illustrate and manipulate designs in progress, enabled real-time engineering, which saved valuable time in realising the project.

WHP’s Managing Director, Nigel Hall, said: ‘We have gained a strong reputation for our cleanroom design and construction in the biotechnology industry and the number and quality of projects that we have in the pipeline continue to grow. We are delighted to have brought our wealth of expertise in stringently-regulated sectors to OXB’s facility and look forward to supporting them in any future expansion plans.’

Technical specifications

The WHP team installed a steel frame mezzanine deck with a loading of 5.7KN/m2 to accommodate a plant area for nine air handlers and ductwork, a compressor package, new switchroom and new boiler room, along with all associated control systems. The Variable Air Volume (VAV) system serving each room includes supply and extract HEPA filtration using constant volume boxes and motorised dampers to maintain the correct volumes under varying pressures. The Building Management System (BMS) and Facility Management System (FMS) control and monitor the facility.

On the ground floor 560m2 of cleanroom facility was constructed using metal panels, a metal ceiling grid system and a resin flooring system. A bespoke Vaporised Hydrogen Peroxide sterilising chamber was developed and installed to provide automated materials sanitisation into the cleanroom. The cleanroom areas were fully commissioned and validated to ISO 14644-1 Class 7.

The ground floor was constructed using metal panels, a metal ceiling grid system and a resin flooring system

Externally, a new plant enclosure was constructed to house a Dieselec 700kw generator, an SSE transformer and two new Daikin chillers (360kw). Bottle stores, with auto-changeover are also in the external plant areas, with stainless steel supply pipework feeding the gas stations within the facility. A new office space was created, with meeting rooms, kitchen area and breakfast bar. A new lift was installed to satisfy building regulations Part M. LED lighting was used and a central PC-based emergency testing facility installed.

Open and honest approach

Richard Graham, WHP’s project manager for the Yarnton project, believes that the company’s open and honest approach to project management was key in fostering an excellent working relationship. He added: ‘This approach, together with the range of in-house skills that we were able to fully utilise on this project, contributed greatly to the successful completion of the facility.’

The WHP team worked closely and collaboratively with a small team of OXB in-house experts throughout the project

James Miskin, Chief Technical Officer of OXB, said: ‘OXB is delighted with the recent completion of its new GMP cleanroom production facility in Yarnton. The WHP team worked closely and collaboratively with a small team of OXB in-house experts throughout the project, and WHP’s specific expertise, from detailed design to engineering solutions, was absolutely critical in completing this high quality facility in such a short period of time. This was a very successful construction project which meets with OXB’s exacting quality and technical expectations, and is a testament to the quality and attention to detail within the WHP team.’

Bespoke cleanroom system

WHP’s clients include multinational corporations, research and development companies and smaller-scale entrepreneurial companies. It works extensively with SMEs and start-up companies and provides specialist design expertise in NCL Capital’s incubation programme based at Discovery Park, in Kent. It also has its own Technical Centre, where it manufactures and tests equipment in a clean environment.

The company is constantly seeking more efficient and cost-effective ways to deliver appropriate solutions for clients. Not content with conventional cleanroom panel systems, it has been working with global provider Kingspan to develop a bespoke new cleanroom system. This system is now being installed successfully by WHP’s own trained in-house team.

Another current trend which it is developing includes the introduction of the cleanroom ‘pod’. This is a fully autonomous cleanroom, which offers a flexible, multi-purpose and mobile solution: ideal for a start-up enterprise, it can easily be scaled up or relocated with little disruption to production.

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