CLEANROOMS
Case study: MNC CDMO based in North London The challenge
A multinational pharmaceutical manufacturer needed to rapidly expand its GMP-grade production capacity to meet growing project demand. The existing site had tight access, limited floor space, and a live manufacturing environment where unplanned downtime was unacceptable. A traditional construction programme would have taken up to a year, causing noise, dust, congestion, and operational disruption – far too slow for the client’s global pace. They required a compliant, high-performance GMP space delivered quickly and with minimal impact on ongoing operations.
The solution The client chose a fully off-site manufactured, turnkey GMP cleanroom solution. Structural and technical elements – walls, ceilings, doors, HVAC, filtration, controls, and services – were built in TCA’s controlled facility. Key advantages included:
n Ninety-five per cent of construction completed off-site, avoiding site congestion. n Only one week of on-site installation and commissioning. n Factory-controlled production ensuring quality, traceability, and compliance with EU GMP and ISO cleanroom standards. n A turnkey package covering environmental control, pressure regimes, filtration, monitoring, and full qualification. n The manufacturer and client collaborated on the design reviews, risk assessments, and GMP alignment. The environmental control strategy – including AHU design, airflow, HEPA filtration, and pressure cascades – ensured stable, predictable GMP performance and supported long-term scalability. Our project team managed logistics, cranage, mechanical and electrical interfaces, airflow commissioning, and validation without interrupting production.
Results The cleanroom was delivered on time, fully validated, and with just one week of site disruption – a transformative improvement over the expected year-long traditional build. The client gained a stable, energy-efficient, GMP-compliant facility seamlessly integrated into existing operations, with flexibility for future expansion.
Phillip Godden
Phillip Godden, chief executive of Total Clean Air Limited, brings almost three decades of hands-on expertise in clean air, controlled environments, and advanced containment and has established himself as one of the UK’s foremost authorities in the field. Phillip leads a company recognised for engineering excellence, technical depth, and a relentless commitment to quality and compliance across the pharmaceutical, life sciences, healthcare, and manufacturing sectors.
Balancing flexibility with compliance While flexibility is a key driver in modern cleanroom design, it must always be balanced against the need for strict regulatory compliance. Reconfigurable or modular systems must be designed in such a way that any changes can be implemented without compromising validated states or introducing contamination risks. This places greater emphasis on robust design principles, clear documentation, and well-defined change control processes. Cleanroom suppliers that can provide standardised yet adaptable systems, supported by comprehensive validation protocols, are increasingly valued by organisations operating in highly regulated environments. In practice, this means designing cleanrooms with future
change in mind. Examples include allowing space for additional air handling capacity, incorporating modular wall and ceiling systems that can be reconfigured with minimal disruption, and ensuring that control systems are scalable and compatible with future technologies.
Sustainability as a competitive differentiator Beyond compliance and cost savings, sustainability is increasingly becoming a competitive differentiator. Organisations are under growing pressure from investors, customers, and regulators to demonstrate measurable progress against environmental, social, and governance (ESG) targets. Given their high energy intensity, cleanrooms represent a significant opportunity to deliver tangible improvements. Reductions in energy consumption, carbon emissions, and waste can all contribute to broader corporate sustainability goals, while also enhancing brand reputation and stakeholder confidence. Furthermore, organisations that invest early in sustainable cleanroom solutions are often better prepared for future regulatory changes, avoiding the need for costly retrofits or upgrades. In this sense, sustainability is not just about meeting current
160 Health Estate Journal October 2026
requirements, but about building resilience and future- proofing operations in an increasingly complex and demanding landscape.
A strategic investment for the future Ultimately, investing in a sustainable cleanroom is a strategic decision, particularly where delayed delivery can directly impact revenue, compliance and competitiveness. n For research-intensive and R&D organisations, deadlines are frequently linked to funding and innovation cycles. Failure to meet a funding milestone can jeopardise funding or delay reporting obligations. Beyond that, time to drug release may significantly affect our global population. As we have seen over the last few decades with Swine Flu, Ebola, and COVID, outbreaks are no longer confined to narrow regions, with active global threats on the horizon for Avian Influenza, Mpox, and Dengue Fever.
n In testing and analytical laboratories, cleanrooms are essential for delivering accurate, accredited results. Commercial labs may depend on fast classroom installation to meet additional contract demands and key performance indicators.
n In the manufacturing field, fast delivery of new cleanroom facilities or expansion of current, directly impacts production scale-up and supply chains. In the health sphere, this is critical in fields from pharmaceuticals to biotech. Inability to meet deadlines can affect product launches, validation batches, and regulatory submissions.
n Contract Manufacturing Organisations (CMOs) / Contract Drug Manufacturing Organisations (CDMOs) tend to work in a just in time environment, speedily gearing up cleanroom capacity when they win a new client, and depending on dedicated modular facilities to allow separation between projects. Faster speed of expansion or delivery of new cleanrooms means faster start-time on the contract, along with competitive advantage during contract negotiations.
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