What Is a Cleanroom? Definition, Process, and Modular Solutions
Cleanrooms are essential for industries where even microscopic contaminants can compromise safety, accuracy, or compliance. From medical device production to aerospace engineering, cleanrooms create controlled environments that protect sensitive processes and products from airborne particles, temperature fluctuations, and other variables.
In this guide, we’ll define what a cleanroom is, explain how the cleanroom process works, review key cleanroom components, and show how Panel Built’s modular cleanroom systems deliver fast, flexible, and compliant solutions for manufacturing and laboratory applications.
What Is a Cleanroom?
Definition of a cleanroom:
A cleanroom is a controlled environment where the concentration of airborne particles is regulated to specific standards. Airflow, temperature, humidity, and pressure are maintained within strict parameters to protect sensitive manufacturing or research processes.
Cleanrooms are used in sectors such as:
- Medical device manufacturing (medical clean rooms)
- Pharmaceutical production
- Food processing
- Aerospace and semiconductor manufacturing
- Biotechnology and life sciences
These environments are often required to meet FDA, ISO, or other regulatory standards, making them a critical investment for compliance and quality control.
How the Cleanroom Process Works
Cleanrooms operate by filtering, circulating, and pressurizing air to remove airborne contaminants and maintain a stable environment.
Key Cleanroom Components
- Cleanroom Envelope – A sealed space, often built inside a larger facility, that physically separates the cleanroom environment from surrounding areas.
- HEPA Filters – High-Efficiency Particulate Air filters trap at least 99.97% of particles ≥0.3 microns, including dust, pollen, mold, and bacteria.
- Cleanroom Ventilation – Air is supplied from ceiling-mounted filters and returned through low-wall returns or integrated wall chases for continuous recirculation.
- Positive Pressure Systems – In most cleanrooms, the air pressure inside is higher than outside, pushing filtered air outward when doors open to prevent contaminants from entering.
- Anterooms & Buffer Zones – Transitional spaces that reduce particle transfer between areas.
The International Organization for Standardization (ISO) defines nine cleanroom classes based on the maximum allowable particle count per cubic meter of air.
|
ISO Class |
Federal Standard (FED-STD-209E) |
Max Particles ≥0.5µm per ft³ |
Example Use Case |
|
ISO 8 |
Class 100,000 |
100,000 |
General manufacturing clean rooms |
|
ISO 7 |
Class 10,000 |
10,000 |
Pharmaceutical compounding |
|
ISO 5 |
Class 100 |
100 |
Semiconductor manufacturing |
Note: ISO 9 is equivalent to normal room air, while ISO 1 is so clean it’s rarely achieved outside of specialized research facilities.
Contamination Control: People Are the Biggest Risk
Surprisingly, people are the number one source of cleanroom contamination. Walking into a cleanroom can introduce dust, dirt, fibers, and even food particles.
To minimize contamination, protocols may include:
- Full-body gowns, gloves, boots, and respirators
- Specialized cleanroom footwear
- Strict entry/exit procedures in gowning rooms
- Air showers or air curtains in high-level cleanrooms
The higher the cleanroom classification, the more rigorous the gowning process and contamination control measures.
Benefits of Modular Cleanroom Systems
Building a cleanroom from scratch (stick-built construction) can be time-consuming and disruptive. Panel Built’s modular cleanroom systems provide a faster, more flexible, and cleaner alternative.
Advantages of Modular Clean Rooms
- Speed of Installation – Prefabricated panels are manufactured off-site and installed quickly with minimal disruption to your operations.
- Custom Design – Layouts tailored to your exact process and classification requirements.
- Scalability – Easily expand, reconfigure, or relocate your cleanroom as needs change.
- Reduced Waste – Pre-manufactured components mean less material waste and on-site debris.
- Regulatory Compliance – Designed to meet ISO and FDA cleanroom requirements.
Why Choose Panel Built for Your Cleanroom Project
For over 25 years, Panel Built, Inc. has designed and installed modular cleanroom systems for clients across the United States and internationally. We provide:
- Turnkey Solutions – From design and manufacturing to shipping and installation.
- Custom Materials – Non-porous, cleanable FRP or other specialized wall facings.
- Industry Expertise – Collaboration with leading cleanroom technology providers.
- Proven Performance – Cleanroom environments tailored to your classification level and process needs.
Making the Right Choice for Your Cleanroom Needs
Cleanrooms are essential for protecting products, processes, and people in high-precision industries. Whether you need an ISO 8 manufacturing clean room or a high-grade ISO 5 cleanroom environment, understanding the components, processes, and classifications will help you make an informed investment.
With Panel Built’s modular cleanroom systems, you get speed, flexibility, and compliance without the headaches of traditional construction.
Design Your Ideal Cleanroom
Ready to design a cleanroom that meets your exact specifications? Contact Panel Built today to discuss your cleanroom project, request a custom quote, or learn more about our modular solutions. Call us at 800.636.3873, email info@panelbuilt.com, or connect via LiveChat on our website. Let’s build the cleanroom environment that will power your success.