Thermo Fisher Scientific

In an effort to bolster their response to the ongoing battle against COVID-19 and to prepare for future growth, Thermo Fisher Scientific announced an expansion of its operations in North America and Europe. This strategic move is geared toward accelerating innovation and enhancing productivity for their valued customers.

The Swindon site expansion is a testament to the global demand for sterile pharmaceuticals and will play a vital role in the expedited development of vaccines and treatments for various diseases, including COVID-19. Thermo Fisher Scientific remains at the forefront of the global response to the pandemic, with its Swindon site securing investment from Pfizer, positioning it as a crucial production hub for the worldwide supply of the Pfizer-BioNTech COVID-19 vaccine.

Partnering with Thermo Fisher Scientific in this ambitious project, Area leveraged its end-to-end laboratory design and construction expertise. As a company known for innovation and excellence, we were excited to collaborate with Thermo Fisher Scientific, a partnership that not only supports their evolving operational needs but also involves creating an environment that further solidifies their position as industry leaders. Our aim was to design and build a space that fosters innovation and offers a workspace capable of attracting and retaining top talent.

The Swindon expansion project transforms the existing 300,000 sqft site into a fully equipped commercial manufacturing facility, providing both short and long-term capacity for various pharmaceutical projects, including the pandemic response. This expansion features an 8,000 sqft Chemistry laboratory with facilities for Good Manufacturing Process (GMP) drug substance analysis, in-process and drug product release analysis, stability testing, and raw material testing.

The project also includes the expansion of a 7,000 sqft Microbiology laboratory, offering services for microbiological testing of raw materials and final products, batch disposition, and ongoing stability program support, including endotoxin, bioburden, and growth promotion analysis.

With a mission to accelerate innovation and enhance productivity for its customers and people, investments in capacity and technology extend beyond the laboratory environment, with a new Beyond the laboratory environment, Thermo Fisher Scientific invested in a new 6,000 sqft activity-based working office space, designed to enhance collaboration between senior managers and support services. This modern office space offers various workstations, meeting rooms, soft seating options, booths, and focus areas, promoting flexibility and choice for their employees. The renovation involved extensive changes, including asbestos removal and utility decommissioning, which increased the office footprint by over 20%.

The transformation is striking, with the bright, open-plan workspace in stark contrast to the pre-existing dark and cellular work floor. Light is used as a central design element, with glazed internal partitioning and new furniture, booths, and meeting rooms elegantly framed by light or backlit, creating an inviting and dynamic workspace.

The Chemistry Laboratory, designed to seamlessly blend workspace and laboratory areas, features a central pathway that serves as a thoroughfare between the east and west wings, connecting the office, changing rooms, clean areas, and the dirty/back of house sections. Equipment placement has been meticulously planned to optimise workflow, with custom-built joinery, stainless steel benchtops, and balance benches catering to the laboratory's specific needs. The laboratory accommodates medical facilities, sterile fill and finish lines, cold chain storage for vaccines with ultra-low temperature requirements, walk-in incubators, endotoxin areas, sterility and bioburden labs, PPE changing facilities, and wash-up rooms.

Notable features of the Chemistry Laboratory include:

• PPE changing facilities equipped with handwash stations at both entrances.
• High purity liquid chromatography (HPLC) equipment.
• Thermal area with ovens and ice machines, complete with a dedicated extractor fan.
• A gas chromatography (GC) room with specialised gases.
• Recirculating cabinets and balance enclosures.
• A kitting area with downflow benches.
• Fume hoods for the preparation of potent solvents.
• Various storage rooms, including cold rooms, cold stores, an ambient store, roller racking storage, a freezer room, and an ultra-low freezer room.

Compliant with:

• EudraLex Volume 4: Chapter 3 Premises and Equipment
• ISO 15190: 2020
• MHRA: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017
• Health and Safety at Work (1974)
• Management of Health and Safety at Work (1999)
• COSHH Regulations

The Microbiology Laboratory plays a vital role in the analysis of air and surface samples from Thermo Fisher Scientific's Patheon facility. This facility supports routine and dynamic batch monitoring, including colony-forming unit (CFU) analysis and organism identity testing, as well as testing of utilities like purified water (PW), water for injection (WFI), and process gasses. Additional functions cover water testing, environmental monitoring, sterility testing, sample incubation, diagnostic identification, and media storage.

The Swindon expansion has introduced a commercial manufacturing model (CMO), providing end-to-end capacity for Thermo Fisher Scientific's customers, increasing site stability and growth potential.

Key features of the Microbiology Laboratory include:

• A sample receipt area for production samples, complete with segregation of quarantine, released, and rejected items, with controlled storage at 2-8°C and ambient temperature.
• Walk-in incubation areas at ambient 20-25°C and 30-35°C for sample incubation.
• A dedicated Grade D equivalent controlled environment for in-process bioburden testing, featuring biosafety cabinets and under laminar flow cabinets.
• A changing area with one-way material flow transfer hatches into necessary subsections.
• An endotoxin testing area designed to minimise vibration and disruption.
• A sterility testing area with isolators within a controlled Grade D equivalent background.
• A diagnostic testing laboratory with negative pressure, designed to meet Class 3 Isolates.
• Autoclaves for porous and fluid loads, as well as discard runs.
• A glassware washer and a wash-up area for washing bottles and disposing of biohazard and raw materials.

Compliant with:

• EudraLex Volume 4: Chapter 3 Premises and Equipment
• EudraLex Annex 1: Manufacture of Sterile Products
• ISO 15190: 2020
• MHRA: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017
• Health and Safety at Work (1974)
• Management of Health and Safety at Work (1999)
• COSHH Regulations

The 2,500 sqft changing room facility has undergone a complete refurbishment, with a focus on improving cGMP compliance. This facility now includes personal lockers, storage spaces, gowning rooms, and ablution amenities. It plays a crucial role in accommodating the ongoing growth and expertise investments at Thermo Fisher Scientific, ensuring efficient entry for specialist, supervisory, and control personnel.

For more information on Patheon’s GMP Changing Room Space, view our case study here.