Cleanrooms and laboratories are an increasingly important part of the UK’s infrastructure. The life sciences sector is booming, contributing £94 billion annually to the economy while driving significant advancements in public health and technology.
The reshoring of semiconductor manufacturing and other vital tech components will only add to the growing need for lab space, cleanrooms, and similar facilities.
Huge amounts of investment are being channelled into supporting these sectors. Venture capital funding for pharma and biotech has surged by 77% in the UK, while the British Business Bank reports that life sciences consistently outperforms other sectors in delivering strong investor returns – making it an attractive prospect for future investment.
The government itself has committed to investing £500 million in the sector and hopes to see it create 100,000 new jobs by 2030.
Yet, there is a massive shortage of the facilities that support the work and future growth of these companies. At the start of 2024, one study suggested the demand for lab space in London alone reached 90,500 sqm, while available supply was just 16,700 sqm – the tale is likely to be similar, or even starker, in other parts of the country where access to capital for development can be more difficult to come by.
In short, the UK needs more cleanrooms, labs, and other facilities that can underpin the growth of vast amounts of investment in the life sciences, biotechnology, microelectronics, and related sectors.
Based on our experience of working on a range of projects in this area, this is how we can ensure that cleanrooms are designed, delivered, and validated to the highest standards of quality and compliance.
In short, the UK needs more cleanrooms
A specialised approach
Unsurprisingly, given the nature of the work undertaken in cleanrooms, they require a very different approach to construction than many other types of buildings. In fact, they demand precise engineering and strict adherence to regulatory standards to ensure the facilities meet the sector’s complex needs and regulatory requirements.
While each project will be unique to the intended purpose of the cleanroom, there are a number of phases that underpin the validation and qualification processes used in the likes of life sciences, medical devices, and microelectronics. Each stage ensures that facilities operate reliably, meet stringent industry regulations, and support the production of safe, high-quality products.
Defining the need – URS and DQ
The journey to creating a functional cleanroom begins with defining its exact requirements. A detailed document, known as the User Requirement Specification (URS), outlines the parameters the room needs to operate within, such as temperature control and humidity regulation. Many of these requirements will be determined by the type of product being manufactured.
Cleanroom classifications are also established during the URS phase using the International Standards Organisation (ISO) system. These range from ISO Class 1, the cleanest level with the strictest limits on airborne particles, to ISO Class 9, which allows for a higher concentration of particulate matter.
The Design Qualification (DQ) stage in the validation process verifies whether the new or modified design meets the specified criteria outlined in the URS. Close collaboration with clients is crucial to fully understanding their specific needs and translating them into a clear, actionable plan.
At this stage, it is equally important to establish a clear construction contract. The contract should include validation requirements, placing responsibility on the contractor to meet these standards during the installation and validation processes.
The required classification depends on the sensitivity of the processes or products involved. For example, ISO Class 1 is typically necessary in environments where processes such as the preparation of sterile pharmaceuticals or the processing of ultra fine particulates in electronics take place.
Building to specification – IQ
Once the URS is established, the process moves through a structured sequence to ensure compliance with the agreed specifications. After the design phase, the next steps are on-site installation, followed by Installation Qualification (IQ), and then testing and commissioning.
During IQ, all systems and components – including pipes, valves, and ventilation systems – undergo thorough inspections to confirm proper installation and alignment with the design specifications.
Any deviations identified during this phase must be corrected to ensure the installation aligns with the design and meets the required standards. The purpose of this process is to document and verify that the installation has been executed precisely according to the design specifications.
Meticulous compliance during IQ helps prevent costly delays and ensures functionality by identifying and addressing any issues early. While IQ is a critical step, it is just one part of the overall validation process. Complete assurance that the environment is ready for manufacturing and bringing products to market can only be achieved once the entire validation sequence, including OQ and PQ, is successfully completed.
Meticulous compliance during IQ helps prevent costly delays
Proving performance – OQ and PQ
The Operational Qualification (OQ) stage comes in when the facility actually starts running and tests whether it performs under real-world conditions as intended at the design stage. The phase involves extensive evaluations, including measuring temperature, humidity, air pressure, and particle counts, as well as monitoring airflows to ensure that, where relevant, fumes are properly contained and external air is prevented from entering.
Validation is achieved when the facility demonstrates it can reliably maintain these necessary conditions. For life sciences companies, medical device manufacturers, and biotech firms, validation is critical – not only for regulatory compliance but also for guaranteeing the safety and efficacy of products.
However, OQ is not the final step.
After the facility is handed over, clients typically conduct Process Qualification (PQ) as they begin running their operations within the cleanroom. PQ ensures that the facility consistently supports production under real-world conditions. While this stage is usually the client’s responsibility, it is an important part of the overall validation process.
OQ is not the final step
Futureproofing the UK’s life sciences sector
Addressing the current cleanroom shortage isn’t just about meeting today’s demand; it’s about creating adaptable infrastructure that meets strenuous standards and supports a constantly evolving industry.
Achieving these goals requires collaboration across developers, contractors, and life sciences companies, ensuring expertise is applied at every stage – from design through to operation.
Meticulous attention to detail at each phase is also crucial to avoid delays, costly errors, or the risk of delivering a facility that the client is not authorised to use. Each stage of the build has its own set of checks and documentation to ensure the facility meets the required specifications, operates as it should, and any defects are identified and fixed early on.
The UK’s life sciences sector is thriving, but sustaining and accelerating its growth relies on infrastructure keeping pace. By tackling the cleanroom shortage and delivering cutting-edge, versatile facilities, the UK can cement its position as a global leader in innovation.