How to Plan a GMP Cleanroom Project

Planning a GMP-compliant cleanroom is one of the most critical investments a pharmaceutical or biotech company can make.

Whether you’re manufacturing sterile injectables, advanced therapies or diagnostic reagents, your cleanroom must meet strict regulatory and operational requirements and be designed for long-term performance, flexibility and compliance.

At Dalkia Cleanrooms, we’ve delivered GMP environments across the UK for both large-scale and specialist pharmaceutical producers. Here’s a step-by-step guide to help your team plan effectively from day one.

1. Define Your GMP Classification Needs

Start by confirming the GMP grade (A–D) required for your intended process. This will shape every part of your design from airflow patterns to materials and environmental controls.

Tip: Early involvement from your QA/validation team can reduce costly redesigns later.

2. Identify Process Flows and Layouts

Map out your personnel, product, waste and material flows. Avoid cross-contamination risks by maintaining clear separations between clean and dirty zones, sterile and non-sterile areas, and high- and low-grade zones.

A process-led layout ensures regulatory compliance and optimised operational efficiency.

3. Choose the Right Construction Method

For GMP cleanrooms, modular systems are often preferred due to ease of cleaning, speed of build, and proven compliance. Prefabricated panel systems allow for quicker deployment and scalable upgrades over time.

Dalkia offers full architectural, mechanical and electrical integration for GMP builds.

4. Integrate Environmental Controls

GMP cleanrooms must control temperature, humidity, airflow and pressure differentials within tight parameters. Specify HEPA or ULPA filtration, airlock designs, and dedicated HVAC systems early in the planning stage.

Environmental control is not just about comfort — it’s a compliance essential.

5. Plan for Validation and Lifecycle Compliance

Build with validation in mind. This means using GMP-compliant materials, designing for easy maintenance, and ensuring every system (HVAC, pressure, access control) can be monitored and documented.

Dalkia Cleanrooms supports clients through full DQ, IQ, OQ and PQ processes.

6. Engage an Experienced Design & Build Partner

Your partner should speak both GMP and engineering. Dalkia Cleanrooms provides turnkey cleanroom delivery — from concept and design through to commissioning and validations supported by in-house MEP expertise and decades of experience in regulated sectors.

Ready to Plan Your GMP Cleanroom?

Dalkia Cleanrooms delivers compliant, high-performance cleanrooms for the UK’s leading pharma and biotech businesses.

Speak to our team today about your next GMP project.