Cleanroom controls need to acheive more than initial compliance, says Phillip Godden. To be effective, you need to take a longer perspective…

A surprising number of cleanrooms are designed to achieve compliance at audit and handover but fall short in terms of supporting long-term goals. 

The real test of maintaining relevant environmental controls over the operational life becomes apparent during the months and years of operation. From the first day of operation, it’s key to implement processes and workflows. These must be stringent whilst also allowing evolution over time, new staff, equipment upgrades, and safely containing the vagaries of human behaviour within defined limits. 

Many facilities are configured primarily to achieve compliance at commissioning. However, the most successful cleanrooms are designed to maintain that level of control throughout years of day-to-day use. 

Compliant facilities, operational problems

One of the biggest issues I note is cleanroom engineering being considered too late or being developed around the available space rather than the actual processes taking place within it. A facility can meet the relevant classification requirements on paper, but decisions around airflow, pressure cascades, personnel and material flows, zoning and equipment positioning can introduce unnecessary contamination risks once the space is operational.

Poorly defined user requirements at the beginning of a project can also lead to changes later in the programme, when they become much more difficult and expensive to accommodate.

This is where smarter planning delivers the greatest value. When cleanroom design begins with a detailed understanding of how a facility will function on a day-to-day basis, contamination risk scan often be addressed before they become operational problems. Digital modelling, process mapping and detailed visualisations allow stakeholders to challenge assumptions and identify pinch points early, reducing risk and avoiding costly modifications once construction has begun. 

Early planning is key

The most successful projects are those where the processes are fully documented and understood before the cleanroom is fully specified.  

Mapping the dynamics of the space through detailed renders and walkthroughs identifies how people, materials, waste and equipment will move through the facility. This allows the layout, zoning, airlocks and HVAC strategy to be developed around the specific life science activities.

Through more than 30 years in the industry, I have seen that relatively small decisions made during the early design stages can have a significant impact on how effectively the facility operates. Early collaboration between the client, cleanroom designer and other stakeholders is extremely important.

The real objective is creating an environment that remains effective, adaptable and efficient throughout its lifecycle

Operational friction can lead to difficulties in maintaining standards, but this collaboration stage drills down to details which may otherwise be overlooked, such as pressure differentials lost during material transfers, and checking that airflow is not blocked by lab equipment. 

This collaborative approach also helps projects move more quickly. By involving stakeholders from the outset, potential challenges can be identified and resolved before they affect construction schedules, commissioning activities or validation programmes. Ultimately, investing more time at the planning stage often results in a faster route to an operational facility. 

Creating a cleanroom for long-term success requires an understanding of the entire facility lifecycle. Decisions taken during design affect construction, commissioning, validation, maintenance and future upgrades. A cleanroom may achieve compliance at handover but maintaining contamination control over many years depends on how effectively those lifecycle requirements have been anticipated from the outset. Having visibility across every stage helps identify potential challenges before they become operational or regulatory risks. 

A detailed User Requirement Specification (URS) should take into account future-proofing and evolving research methods. Typically, we work in tandem with a client to develop the URS or guide them through what’s needed. 

A robust URS should look beyond immediate requirements. Research methods evolve, regulations change and organisations grow. Designing flexibility into the facility from the beginning can significantly reduce future disruption and protect the original investment. Whether that means allowing capacity for additional equipment, adapting workflows or accommodating future regulatory requirements, forward-thinking design is about creating a facility that can evolve alongside the organisation it serves. 

Designing for the future: LifeCells NI

A recent project for LifeCells NI is a practical example of designing for future capability rather than immediate compliance. The facility has ambitious plans to cater for life science needs across Northern Ireland and Ireland as well as users from mainland UK and Europe and has been developed with future growth in mind. It is on track to gain a Human Tissue Authority (HTA) licence this year, after which it will look at MHRA status. This will allow the facility to be used for cell therapy, for cancer and diabetes research, CAR-T therapy to drive forward personalised medicine in Northern Ireland.

The cleanroom was designed to support consistent laboratory processes, giving researchers and laboratory staff access to an environment focused on efficiency and control. Critical equipment is integrated seamlessly into the layout, while personnel and material flows have been carefully considered. Environmental systems operate unobtrusively in the background, underpinning day-to-day activities without creating unnecessary complexity.

Importantly, the facility has been designed with safety at its core. Effective contamination control is ultimately about protecting the integrity of research, biological materials and patient outcomes. By carefully controlling people, process environmental interactions, the cleanroom helps minimise risk while supporting the high standards required in advanced healthcare and life science applications. 

Modular benefits 

Modular construction can also underpin contamination control throughout the functional life of a facility. By using pre-engineered, factory-validated modular solutions, laboratories can lock in compliance, ensuring the environment is inherently stable, rather than relying on site-based, "stick-build" variability that may introduce risks during construction.

Bespoke or tailored builds allow the engineering to be precisely tailored, facilitating airflow distribution and recovery to specific zones and outlets, ensuring the right amount of clean air reaches defined areas. With energy costs being a notable budget line, this also helps improve energy efficiency and avoids unnecessary air changes or excessive noise. More importantly, it helps facilities maintain the environmental control needed to support compliance and microbial management throughout their operational life. 

Modular solutions can also support quicker delivery programmes. Factory-controlled manufacturing environments allow systems to be assembled, tested and validated before arriving on site, reducing programme risk and helping customers reach operational readiness sooner. For organisations facing tight commercial or research deadlines, that can be a significant advantage. 

Look beyond the handover

Successful cleanroom projects do not end at handover. Long-term performance depends on continued monitoring, maintenance, training and support. Even the most advanced facility can struggle if operational practices are not maintained or if future changes are introduced without considering their impact on contamination control. 

Delivering a compliant cleanroom is only the starting point. The real objective is creating an environment that remains effective, adaptable and efficient throughout its lifecycle. That means combining smarter planning, quicker delivery, safer operations and a genuine commitment to supporting our customers long after the project has been completed. 

By taking a lifecycle approach from the outset, organisations can create cleanrooms that not only achieve compliance on day one, but continue to support innovation, research and manufacturing excellence for years to come. 

Philip Godden is CEO of Total Clean Air