These highly controlled environments are engineered to limit airborne particles, temperature fluctuations, and microbial contaminants, making them the backbone of sectors such as biotechnology, semiconductor manufacturing, and medical device production.
So what does it take to design and build these specialised spaces? Our Managing Director, Mark Davey, breaks down the process involved in delivering an operational cleanroom that is fit for purpose and future-proofed.
Cleanrooms don’t just go up overnight. Behind every high-performing facility is a clearly defined process. One that strikes a balance between technical accuracy and practical execution. Most cleanroom design and build processes typically follow five core phases: Planning, Design, Construction, Validation, and Maintenance. Each phase builds upon the last to ensure performance, compliance, and operational integrity.
The process begins with a comprehensive needs assessment and risk analysis. During this phase, project teams define:
• Intended processes and equipment which will drive:
• Occupancy levels and personnel flow
• Regulatory and operational constraints
• Required cleanroom classification, such as ISO 1 to 7 and ballroom or bay and chase styles
These inputs inform the Scope Definition – a foundational document that guides all downstream decisions. Early-stage planning also considers production needs, energy efficiency, and long-term scalability, ensuring the cleanroom remains viable as operations evolve. Planning for the future from the get-go reduces the risk of more costly modifications and manufacturing shutdowns being needed further down the line.
The design phase translates those strategic requirements into technically defined solutions. This includes:
• Zoning and Layout Design: Configured for process flow, contamination control, and accessibility
• Materials Specification: Non-shedding, antimicrobial surfaces and finishes
• HVAC Engineering: Tailored for temperature and humidity control, pressure differentials, airflow patterns, and filtration performance
• Control Systems Integration: Environmental steady state control and monitoring systems, alarms, and digital controls for real-time visibility and data logging.
The goal is to achieve a seamless integration of mechanical, electrical, and architectural systems that can maintain stringent conditions. Each element can’t be considered in isolation, as these solutions have to work together to deliver a cost-effective and operationally flexible environment that maximises uptime and product quality.
Cleanroom construction is executed under tight contamination control procedures. Highly experienced specialist contractors install work package components, such as HEPA terminals, wall and ceiling panels, cleanroom doors and windows. They use specific industry methods that minimise particle generation during the build.
Key aspects of this phase include:
• Sequencing installations – for example, beginning with independently supported fire-rated cleanroom ceilings, then progressing to walling, windows, and doors, and completing with floor screed and anti-static vinyl flooring to minimise damage during construction.
• Maintaining cleanliness standards throughout construction with the mantra ‘build clean, stay clean’.
• Larger items such as ductwork and gravity drains that take priority routing would come next, followed by smaller bore pressurised systems like gases and chemicals that may be able to be more flexible in their routing.
• The key to construction is operability and maintainability to maximise production and quality.
Construction quality directly affects the cleanroom’s ability to pass validation and meet ongoing performance expectations.
Validation ensures that the cleanroom meets defined environmental and operational standards. New and existing cleanroom environments undergo a range of tests, which are often legal requirements. This is particularly the case in heavily regulated industries such as pharmaceuticals and medical devices.
This phase can include:
• Airflow visualisation for laminar or turbulent flow
• HEPA DOP filter leak tests
• Particle count testing for ISO classification
• Temperature and humidity mapping
• Regulation of supply and return ventilation systems to confirm that design parameters are met
Documentation from this phase is critical for both regulatory audits and internal quality assurance.
Cleanrooms are not static environments. Continuous monitoring, preventive maintenance, and periodic revalidation are essential for sustained compliance.
Modern facilities often deploy IoT-enabled sensors and building management systems to track performance metrics in real time, enabling predictive maintenance and minimising unplanned downtime.
Formal training programmes for cleanroom personnel also play a key role in maintaining environmental control and reducing human-borne contamination risks.
Like the industries they support, cleanroom design isn’t standing still. Modular cleanroom systems are reducing construction timelines, while advanced automation and real-time monitoring are improving operational resilience.
As regulatory expectations tighten and product complexity grows, the cleanroom design and build process is becoming a strategic capability – one that requires technical precision, cross-functional collaboration, and a deep understanding of controlled environment science.
