Pharmaceutical Cleanroom Design

Pharmaceutical cleanroom design is essential for maintaining product integrity, ensuring regulatory compliance, and enabling safe pharmaceutical production. At KeyPlants, we design and deliver cleanroom environments that meet the highest GMP standards, tailored to your specific process, facility, and scalability needs.

What we deliver in pharmaceutical cleanroom design

GMP-Compliant Cleanroom Design

We deliver cleanrooms that meet global GMP standards, supporting safe, compliant, and high-quality pharmaceutical production.

Modular Cleanroom Design & Delivery

Our prefabricated cleanrooms reduce timelines and enable fast deployment with minimal disruption to your ongoing operations.

ISO Classification & Zoning Strategy

We define ISO classes, zoning, and pressure regimes to maintain strict environmental control tailored to your process requirements.

HVAC & Environmental System Design

We integrate HVAC, temperature, humidity, and pressure control to ensure stable, validated, and energy-efficient cleanroom conditions.

Contamination Control & Process Flow

Our layouts are designed to minimize contamination through optimized flows for personnel, materials, and waste management.

Fully Integrated Design & Engineering

We manage the full scope of cleanroom design - from initial concept through detailed engineering and documentation.

GMP-Compliant Solutions

Cleanroom Design for Critical Environments

We specialize in pharmaceutical cleanroom design for advanced, regulated environments. Our expertise spans from CNC and Class D spaces, through to aseptic production and high-containment cleanrooms, always tailored to meet GMP and FDA/EMA requirements. Every design ensures precise airflow control, temperature and humidity stability, and minimized contamination risk - supporting the highest levels of product and patient safety.

Pharma facility design
Process-Driven Layouts

Tailored Solutions for Every Manufacturing Process

We understand that no two manufacturing processes are identical. That’s why our cleanroom designs are fully adapted to your production flow, spatial constraints, and regulatory framework. Whether you need unidirectional personnel and material flow, zoning strategies, or scalable layouts for future expansion, we collaborate closely with your team to ensure a cleanroom that fits both your operations and long-term strategy.

Process driven layout
End-to-End Alignment

Seamless Integration with Facility & Process

Our cleanroom solutions are never designed in isolation. We align cleanroom layouts with the full facility design and production process to ensure functionality, compliance, and cost-efficiency. This integrated approach simplifies engineering, speeds up project delivery, and reduces on-site risks - whether the cleanroom is part of a greenfield facility or integrated into an existing production environment.

End-to-end alinment
Fast, flexible, future-ready

Explore our modular cleanroom pods

Our pre-manufactured cleanroom pods combine the same GMP-design expertise you rely on, with a modular platform built for rapid deployment, scalability and reuse. Whether you’re expanding capacity, adapting to new processes or entering a new market, our pod solutions install within weeks, integrate seamlessly with existing infrastructure and minimise downtime.

Read more about Cleanroom pods
Cleanrooms

FAQ

What is pharmaceutical cleanroom design?

Pharmaceutical cleanroom design involves creating controlled environments that meet strict cleanliness and environmental standards for drug manufacturing. This includes regulating temperature, humidity, air pressure, and particle levels in compliance with GMP and ISO classifications.

What cleanroom standards does KeyPlants design to?

KeyPlants designs cleanrooms in compliance with international standards such as EU GMP Annex 1, ISO 14644, and FDA cGMP. Our solutions are tailored to meet the specific regulatory requirements of your production processes and target markets.

Can cleanrooms be designed for both new and existing facilities?

Yes. We offer cleanroom designs for both greenfield and brownfield projects. Our modular approach makes it possible to integrate new cleanrooms into existing buildings with minimal disruption and high design flexibility.

How does KeyPlants ensure contamination control in cleanroom design?

We implement proven zoning strategies, unidirectional flows, HEPA filtration systems, and proper material/personnel segregation to ensure contamination risks are minimized throughout the cleanroom environment.

Does KeyPlants offer turnkey delivery of cleanroom facilities?

Yes. In addition to design, KeyPlants provides complete turnkey delivery — from engineering and prefabrication to installation and commissioning. This ensures speed, cost control, and quality throughout the entire cleanroom lifecycle.

Why choose KeyPlants?

Holistic Process Approach

We provide full-spectrum process engineering solutions, covering everything from concept to execution. Our expertise ensures compliance, efficiency, and sustainability in pharmaceutical and biotech manufacturing.

Multidisciplinary Expertise

We offer our clients the flexibility to choose their own equipment, whether they've decided on conventional construction, or they're taking advantage of KeyPlants’ modular manufacturing capabilities. 

Modular & Scalable Solutions

Rapid deployment of prefabricated, high-tech facilities ensures manufacturers can quickly adapt. Our modular approach reduces construction time, lowers costs, and enhances scalability for expanding or launching new facilities.

Client-Centric Innovation

We create tailored process solutions to meet unique business needs. By focusing on flexibility, digital automation, and compliance, we help clients build future-proof manufacturing systems.

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