How to Build an ISO 7 Cleanroom: Standards, Design, and Modular Solutions

Maintaining a controlled environment is essential for industries like pharmaceuticals, electronics, aerospace, and advanced manufacturing, where even microscopic particles can compromise product quality or research integrity. An ISO 7 cleanroom provides the balance of cleanliness, flexibility, and cost-efficiency that many modern facilities require.

At Panel Built, Inc., we specialize in modular clean room systems that meet ISO, GMP, and FDA standards, allowing you to create a fully compliant cleanroom quickly and efficiently. In this guide, we’ll explain what an ISO 7 cleanroom is, how it’s classified, common sources of contamination, and how modular construction simplifies the process of building and maintaining a clean, high-performance environment.

An ISO 7 cleanroom—also referred to as a Class 10,000 cleanroom—is a controlled space where airborne particles, temperature, humidity, and pressure are carefully regulated to protect sensitive processes or materials.

According to the ISO 14644-1 standard, ISO 7 cleanrooms allow a maximum of 352,000 particles (≥0.5 µm) per cubic meter of air. This level of control is achieved through advanced HEPA filtration, controlled airflow, and specialized construction materials designed to minimize particle shedding and contamination.

ISO 7 cleanrooms are commonly used in:

• Pharmaceutical manufacturing and packaging
• Electronics assembly and circuit board production
• Aerospace component fabrication
• Medical device manufacturing
• Biotechnology and life sciences research

Even with advanced filtration, contamination can come from many sources. Understanding where it originates is the first step in keeping your cleanroom within compliance.

Primary sources of contamination include:

• Personnel: The single largest source of particles. Humans shed millions of skin cells, hair, and fibers daily, even when stationary.
• Airflow and HVAC systems: Poor filtration or turbulence can circulate unwanted particles.
• Equipment and tools: Machinery, cleaning materials, and garments can shed debris or off-gas contaminants.
• Facility materials: Non-cleanroom-rated surfaces, paints, and papers can release particulates over time.
• Processes: Friction, movement, and static discharge all contribute to airborne contamination.

A single person walking at a normal pace can generate millions of particles per minute, which is why protective apparel and strict entry procedures are so critical in ISO-classified environments.

Traditional cleanroom construction can be time-consuming, disruptive, and costly. A modular clean room offers the same level of performance while significantly reducing installation time and total cost of ownership.

Advantages of Modular Cleanroom Construction

• Faster installation: Prefabricated panels are built off-site and installed quickly with minimal facility downtime.
• Flexibility: Easily reconfigure or expand your cleanroom as operations evolve.
• Compliance built-in: Modular panels meet ISO 7 and other cleanroom classifications right out of the factory.
• Cleanable materials: Non-shedding wall panels, flooring, and ceilings are designed for easy wipe-down and contamination control.
• Cost efficiency: Controlled manufacturing environments reduce material waste and labor expenses compared to traditional builds.

At Panel Built, our modular systems can include integrated airlocks, gowning rooms, pass-through chambers, and fan filter units (FFUs) to maintain consistent particle control and pressure differentials.

Maintaining ISO 7 compliance requires strict attention to how personnel enter, move, and work inside the space.

Recommended Cleanroom Apparel for ISO 7 Environments

Personnel should wear:

• Hair and beard covers
• Frocks or coveralls
• Gloves (nitrile or cleanroom-grade latex)
• Shoe covers or cleanroom boots
• Safety glasses or goggles

Cleanroom Etiquette and Best Practices

• No food, drink, or personal items inside the cleanroom.
• Use sticky mats or air showers at entrances to remove particles from footwear.
• Avoid cosmetics, lotions, or fragrances.
• Move slowly to minimize air disturbance and particle shedding.
• Always sneeze or cough into your arm or a designated corner, away from equipment.
• Keep notebooks, pens, and supplies cleanroom-approved (plastic or metal, not paper or wood).

Even small lapses in protocol can lead to particle buildup, pressure imbalances, or contamination events that compromise quality control.

Cleanrooms are categorized by how many airborne particles they permit per cubic meter of air. The smaller the number, the cleaner the environment.

An ISO 7 cleanroom typically includes airlocks, anterooms, and gowning areas to maintain cleanliness standards during entry and exit.

As a leading modular cleanroom manufacturer, Panel Built designs turnkey systems that meet your exact contamination control and compliance requirements.

Our pre-engineered cleanrooms feature:

• Fully enclosed modular wall systems (available in vinyl, steel, or FRP finishes)
• HEPA filtration and HVAC integration for precise environmental control
• Expandable designs that grow with your facility
• Code compliance with ISO, FDA, and GMP standards

Whether you’re outfitting a new facility or upgrading an existing one, Panel Built makes it easy to build an ISO 7 cleanroom that balances quality, flexibility, and cost efficiency.

Build Your ISO 7 Cleanroom with Panel Built

Contamination control is critical in high-precision industries, and choosing the right cleanroom system is the first step toward maintaining quality and compliance. An ISO 7 modular cleanroom delivers the cleanliness you need without the downtime or disruption of conventional construction, offering a faster path to productivity.

Panel Built has over 25 years of experience designing and manufacturing modular cleanroom systems for industrial and research applications. Whether you’re upgrading to ISO 7 standards or starting from scratch, our team can help you specify, design, and install a cleanroom that meets your exact needs.

Call 1-800-636-3873, email info@panelbuilt.com, or request a quote today to start planning your modular cleanroom project.