Cleanrooms are critical for industries where even the smallest contamination can disrupt processes, compromise research, or damage products. From pharmaceuticals and biotechnology to electronics, healthcare, and food production, organisations rely on controlled environments to maintain precision, safety, and compliance.
This raises two essential questions:
What goes into Cleanroom Design & Construction?
And why is ISO certification so critical?
At Lab Fit, we provide end-to-end cleanroom solutions across the UK — from design and construction to ISO certification and ongoing support. This guide explains the fundamentals of cleanroom design, the role of ISO standards, and how tailored solutions ensure safety, compliance, and efficiency.
What Is Cleanroom Design & Construction?
Cleanroom design and construction is the process of creating a controlled environment where airborne particles, temperature, humidity, and pressure are regulated to precise standards.
These environments reduce contamination risks and support sensitive operations such as:
- Pharmaceutical manufacturing
- Biotechnology research and testing
- Medical device production
- Electronics and semiconductor assembly
- Healthcare and food facilities
Designing and constructing a cleanroom requires careful planning of airflow, filtration, materials, and workflow to meet strict industry and ISO 14644 standards.
Why ISO Certification Matters
ISO 14644 defines the allowable levels of airborne particles in cleanrooms, ensuring global consistency in cleanliness and safety.
- ISO Class 5 – sterile pharmaceutical production and semiconductor manufacturing
- ISO Class 7 – biotechnology and research laboratories
- ISO Class 8 – less sensitive but still controlled environments
Working with an ISO-certified provider ensures your cleanroom is validated against industry standards, giving confidence to regulators, partners, and clients.
Key Requirements of Cleanroom Design & Construction
When planning a cleanroom, several factors determine effectiveness and compliance:
1. Airflow and Filtration
- High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA) filters remove contaminants.
- Positive or negative pressure is maintained depending on the process.
- Laminar airflow reduces turbulence and contamination risks.
2. Zoning and Layout
- Graded zones (ISO 8 through to ISO 5) with airlocks and gowning rooms.
- Clear zoning minimises cross-contamination and protects critical workflows.
3. Materials and Surfaces
- Walls, ceilings, and floors must be smooth, non-porous, and easy to clean.
- Common choices: PVC cladding, stainless steel, and epoxy coatings.
4. Utilities and Services
- HVAC, lighting, power, and data systems must integrate seamlessly without compromising the controlled environment.
5. Validation and Testing
- Before handover, particle counts, airflow rates, and environmental parameters are tested.
- Certification confirms compliance with the required ISO class.
Benefits of ISO-Certified Cleanrooms
Investing in ISO-certified cleanroom design and construction provides long-term advantages:
- ✅ Compliance with regulatory and industry standards
- ✅ Improved product quality and reduced contamination risk
- ✅ Enhanced reputation for meeting ISO benchmarks
- ✅ Efficient, tailored layouts for maximum productivity
- ✅ Scalability and adaptability for future growth
Typical Cleanroom Applications
Our team has delivered cleanroom projects across multiple sectors:
- Pharmaceuticals – sterile manufacturing with ISO 5 classification
- Biotechnology – modular cleanrooms for scalable research
- Electronics – controlled ISO 7–8 environments for microchip assembly
- Healthcare – cleanrooms for diagnostics, medical devices, and hospitals
Each project demonstrates how tailored cleanroom design supports specific industry requirements.
Cost Considerations in Cleanroom Projects
So, how much does cleanroom design and construction cost?
Pricing depends on several factors:
- Required ISO classification
- Size and complexity of the space
- Choice of materials and finishes
- HVAC and utility specifications
- Validation and certification requirements
ISO Class 8 cleanrooms are generally more affordable, while ISO Class 5 environments with advanced systems require higher investment. Early consultation with a specialist ensures accurate budgeting and realistic timelines.
Frequently Asked Questions on Cleanroom Design & Construction
- What does Cleanroom Design & Construction involve?
It covers planning, materials selection, airflow management, HVAC integration, and ISO validation. - Why are ISO standards important?
They ensure your cleanroom meets international cleanliness benchmarks, protecting processes and compliance. - How long does it take to build a cleanroom?
Timelines vary — a few weeks for modular cleanrooms, several months for large-scale permanent facilities. - Can existing spaces be upgraded to ISO standards?
Yes. Specialist refurbishment can transform older labs or production spaces into ISO-certified facilities. - Which industries need cleanrooms most?
Pharmaceuticals, biotech, healthcare, electronics, and food production. - What’s the difference between modular and permanent cleanrooms?
Modular cleanrooms are faster and more flexible; permanent cleanrooms offer greater durability and scalability.
Final Thoughts
Cleanroom design and construction requires more than technical expertise — it demands a deep understanding of ISO standards, industry regulations, and future adaptability.
At Lab Fit, we deliver bespoke ISO-certified cleanroom solutions as part of our wider laboratory fit-out services. From consultation and design through to validation and aftercare, we create controlled environments that help businesses thrive.
Planning a cleanroom project? Contact us today to discuss your requirements, or download our Cleanroom Design Checklist to get started.
