November 25, 2025
Cleanroom: definition, standards, and essential equipment
A cleanroom, also known as a white room, is a controlled environment where every particle counts: temperature, humidity, and pressure are regulated to protect the most sensitive processes. Used in healthcare, industry, and research, they guarantee product quality and safety.
With over 50 years of expertise in France, Medicom supports professionals by combining industrial know-how, local production, and sustainable innovation. It is this unique combination that makes the difference.
What is a cleanroom?
A cleanroom is an enclosed space where particle concentration is strictly controlled to reduce any risk of contamination. Unlike a so-called “clean” room, which simply aims to limit dust, a cleanroom complies with standardized norms and requires rigorous monitoring.
To give you an idea, outdoor air contains several million particles per cubic meter. In an ISO 7 cleanroom, there are fewer than 352,000; in an ISO 5 cleanroom, the threshold drops to just 3,520. These figures reflect the extreme requirements of this type of facility.
The objective remains the same: to protect products and processes. And, by extension, to protect users and patients in sectors where sterility is not an option but an essential requirement.
How does a cleanroom work?
The operation of a cleanroom is based on a simple principle: continuously controlling air circulation and quality. Thanks to high-efficiency filters (HEPA or ULPA), almost all particles, bacteria, and microorganisms are removed from the incoming air.
There are two possible approaches: positive pressure, which prevents outside air from entering the controlled space, and negative pressure, which is used to prevent sensitive substances from escaping. In both cases, temperature, humidity, and pressure are continuously monitored to maintain an optimal balance.
This system is not only technical: it directly affects the purity of the environment and the quality of the products manufactured. This is why cleanrooms have become a strategic tool for all sensitive industries.
Applicable ISO and GMP standards
The design and use of cleanrooms are based on specific international standards. The best known of these, ISO 14644, defines nine cleanliness classes, from ISO 1 (the strictest) to ISO 9 (close to ambient air). Each level corresponds to a maximum number of particles allowed per cubic meter of air. For example, an ISO 5 room must not exceed 3,520 particles of 0.5 microns, while an ISO 7 room tolerates up to 352,000.
In addition to ISO, Good Manufacturing Practices (GMP) impose specific requirements for the pharmaceutical and medical industries. They regulate air flow management, cleaning methods, staff behavior, and process traceability.
Compliance with these standards is mandatory to ensure patient safety and regulatory compliance. It is also a key factor in building trust with partners and health authorities.
Criteria for cleanroom design
The design of a cleanroom cannot be improvised. The materials used must be non-contaminating: no fibers or particles should detach from the surfaces. This is why the walls, floors, and ceilings are often covered with specific coatings that are easy to clean and resistant to disinfectants.
Corners and joints must be rounded to prevent dust accumulation, while pipes are routed outside to limit risk areas. Finally, a decontamination chamber always separates the cleanroom from conventional spaces, creating an additional barrier against particle intrusion.
In short, everything is designed to control contamination and ensure an environment that complies with ISO standards.
Essential equipment for cleanrooms
To operate effectively, a cleanroom must be equipped with appropriate devices that ensure both process safety and personnel protection. Air handling systems, with their HEPA or ULPA filters, are at the heart of the system: they ensure constant circulation and impeccable purity levels.
The furniture—tables, storage units, and flooring—is designed to be non-contaminating, smooth, and easy to disinfect. But the equipment doesn't stop there: operators must wear appropriate PPE such as masks, disposable gloves, coveralls, and shoe covers to prevent the introduction of particles or microorganisms.
At Medicom, the range extends from respiratory protection to sterile clothing and low-shedding shoe covers. Manufactured in France and incorporating recycled materials, this equipment combines safety, comfort, and sustainability. It guarantees a cleanroom that is both high-performance and responsible.
Discover our cleanroom equipments
Because a cleanroom tolerates no compromise, the choice of equipment is crucial. With over half a century of expertise, Medicom offers certified solutions that are manufactured in France and environmentally friendly.
Masks, gloves, coveralls, or shoe covers: each product is designed to protect your teams and your processes.
Protocols and role of staff
Even with sophisticated equipment, the main source of contamination remains the staff. Each operator must follow a strict protocol: dressing in the airlock area, putting on PPE in a specific order, following procedures, and limiting movement.
These rituals may seem restrictive, but they are essential for maintaining sterility. The sterile clothing, masks, and single-use gloves provided by Medicom significantly reduce the risks associated with particles emitted by humans.
Ultimately, the cleanroom is only as effective as the rigor of those who work in it. Discipline and equipment form an inseparable duo.
Areas of application for cleanrooms
Cleanrooms have become indispensable in a variety of sectors, each with its own purity requirements. The pharmaceutical and medical industries use them to manufacture medicines, vaccines, and sterile devices. The cosmetics industry uses them to ensure that its sensitive formulations are free of impurities.
In electronics, they enable the assembly of semiconductors and microscopic components, while the food industry uses them for the packaging of sensitive products. The aerospace industry requires controlled environments for the development of critical equipment.
Research, optics, and advanced chemistry: the list grows as innovations continue to emerge. Every sector finds the same promise in these technologies—consistent quality and impeccable safety.
Why invest in a cleanroom today?
Investing in a cleanroom is not just a matter of regulatory compliance. It is also a strategic choice to improve product quality, secure processes, and strengthen customer and authority confidence.
The global market is growing at an estimated annual rate of nearly 7%, demonstrating the growing importance of these controlled environments in all sensitive sectors. Increased productivity, reduced contamination risks, and a reputation for reliability: the benefits are numerous.
In short, cleanrooms are a competitive advantage.
FAQs about cleanrooms
What equipment is mandatory in a cleanroom?
Masks, gloves, coveralls, shoe covers, and sometimes hairnets: all of this appropriate PPE is essential for limiting human contamination.
How is a cleanroom certified?
An audit based on the ISO 14644 standard measures the concentration of particles in the air, according to the target class. Regular checks then ensure that the required level is maintained.
Which sectors use cleanrooms?
Pharmaceuticals, electronics, cosmetics, agri-food, aerospace, and scientific research: each field has its own purity thresholds.
