How to Plan a Cleanroom Project Around Live Production

Unlike new-build facilities, projects within operational environments must balance construction activities alongside ongoing manufacturing processes.

The risks are significant:

• Production downtime impacting revenue.
• Increased contamination risks.
• Operational disruption for staff.
• Regulatory and validation concerns.
• Restricted access and working hours.
• Health and safety considerations.

A successful project isn't simply about building the new space; it's about protecting the environment that already exists.

The first step is understanding exactly how the facility functions today.

This means assessing:

• Critical production activities.
• Shift patterns and staffing levels.
• Areas with the highest contamination sensitivity.
• Equipment that cannot be taken offline.
• Material and personnel flows.
• Existing cleanroom classifications.
• Validation requirements.

Developing a comprehensive understanding of operational constraints allows the project team to design a programme that works around the business rather than against it.

Early stakeholder engagement is essential to avoid costly surprises later in the process.

Every live production environment has boundaries that cannot be compromised.

Examples may include:

• Zero interruption to specific manufacturing lines.
• Maintaining ISO classifications throughout works.
• Preserving temperature and humidity conditions.
• Protecting ongoing research activities.
• Ensuring uninterrupted utility supplies.
• Meeting GMP compliance obligations.

Documenting these requirements within the project brief helps align all parties from the outset and minimises the risk of scope creep.

A clearly defined User Requirement Specification (URS) provides the foundation for successful delivery.

One of the most effective ways to minimise disruption is through phased delivery.

Rather than attempting to complete all works simultaneously, projects can be broken into manageable stages.

This may include:

Phase 1: Enabling Works

• Temporary service diversions.
• Site segregation measures.
• Temporary access routes.
• Installation of protective barriers.

Phase 2: Construction Activities

• Strip-out works.
• Structural modifications.
• Mechanical and electrical installations.
• Cleanroom envelope installation.

Phase 3: Testing and Validation

• Commissioning activities.
• Environmental monitoring.
• Air balancing.
• Certification and qualification.

Phased delivery allows production teams to adapt while reducing operational risk.

Contamination management should remain at the centre of every decision.

Construction activities generate dust, particles and movement that can threaten sensitive environments.

Control measures often include:

• Temporary hoarding systems.
• Negative pressure construction zones.
• Dedicated contractor routes.
• Controlled waste removal procedures.
• Enhanced cleaning protocols.
• Sticky mats and gowning requirements.
• HEPA-filtered extraction equipment.
• Environmental monitoring throughout the programme.

The objective is to create clear separation between operational areas and construction zones without compromising productivity.

Flexibility is often the difference between project success and failure.

Many live cleanroom projects benefit from working patterns such as:

• Weekend working.
• Evening shifts.
• Planned shutdown periods.
• Seasonal production downtime.
• Out-of-hours service isolations.

Close collaboration between operational teams and project managers ensures critical manufacturing activities remain protected.

Construction should adapt to production - not the other way around.

In some situations, temporary solutions can maintain production continuity while refurbishment works progress.

These may include:

• Modular cleanroom installations.
• Temporary laboratories.
• Decant areas.
• Portable containment systems.
• Interim welfare facilities.

Although not suitable for every project, temporary environments can provide valuable operational resilience during extensive upgrades.

Validation should never be treated as an afterthought.

Bringing validation specialists into the planning stages helps identify potential compliance risks before construction begins.

Typical considerations include:

• Installation Qualification (IQ).
• Operational Qualification (OQ).
• Performance Qualification (PQ).
• Airflow visualisation studies.
• HEPA integrity testing.
• Particle counting.
• Pressure differential verification.
• Temperature and humidity testing.

Planning these activities early reduces delays during handover and accelerates the return to full operational status.

Delivering a cleanroom project around live production requires more than technical capability. It demands an understanding of how operational facilities function and the ability to coordinate numerous moving parts without compromising compliance.

Turnkey delivery models often provide greater confidence because responsibility remains with a single point of contact throughout design, construction, commissioning and handover. This approach can significantly reduce project risk and improve coordination between disciplines.

Upgrading or refurbishing a cleanroom while maintaining live production is undoubtedly challenging, but with the right planning, sequencing and expertise, it can be achieved successfully.

By understanding operational constraints, implementing robust contamination controls and maintaining clear communication throughout the programme, organisations can improve their facilities without sacrificing productivity.

At ParkLaine, we help clients deliver cleanroom design, fit-out and refurbishment projects within operational environments across the UK. Our integrated approach enables businesses to enhance critical spaces while keeping their operations moving.

Planning a Cleanroom Upgrade?

If you're considering a cleanroom refurbishment or expansion within a live production environment, our team can help you develop a strategy that protects both your operations and your investment.

Get in touch to discuss your requirements and discover how ParkLaine can support your next cleanroom project.