Cleanroom Manufacturer
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CRM - A Professional Cleanroom Manufacturer
CRM is a cleanroom manufacturer dedicated to providing high-standard and tailored cleanroom solutions for industries such as semiconductor, pharmaceutical, medical device, food processing, and biotechnology. With rich engineering experience and technological accumulation, we are capable of providing customers with one-stop, full-process services ranging from the initial consultation, scheme design to construction and acceptance. As a professional cleanroom manufacturer, CRM not only provides high-quality materials and equipment, but also attach great importance to construction management and system integration. We strictly implement quality control and acceptance standards to ensure that every project can be completed as planned and with high quality. Through professional and systematic services, CRM helps enterprises create a safe and reliable clean production environment, improve product quality and create core competitiveness for customers in the field of high-standard manufacturing.
Experiences
Over 25 years of experience as a professional Cleanroom Manufacturer
Certifications
ISO9001 approval company, product comply with international standard
Customization
Rich experience in tailor-made Cleanroom Manufacturing
Delivery
Worldwide delivery and short lead time
What Is a Cleanroom?
A cleanroom is a professional production space that strictly controls particulate matter, microorganisms, temperature, humidity, pressure and other environmental parameters in the air, aiming to provide a stable and reliable production environment for high-precision and high-standard manufacturing and scientific research activities. Compared with ordinary production environments, cleanroom can significantly reduce the risks of air pollution and microbial contamination, ensure product quality and production safety.
As a professional cleanroom manufacturer, CRM not only offers design, manufacturing and construction services for cleanroom, but also ensure that each cleanroom meets the production requirements of industry standards through full-process engineering management, providing a solid guarantee for the high-quality production of enterprises.
Characteristics:
High air cleanliness: Particles and microorganisms in the air are removed through high-efficiency filters.
Precise temperature and humidity control: It can ensure the stability of the production environment and the quality of the products.
Pressure gradient design: This design can prevent external contaminants from entering the clean area.
Strict cleaning and maintenance procedure: Regular cleaning and disinfection are carried out to ensure the continuous cleanliness of the environment.
Working Principle of Cleanroom
Cleanroom minimizes the impact of air particles, microorganisms and other pollution sources on the production process through measures such as air cleanliness control, pressure and flow rate management, temperature and humidity regulation, pollution source management, as well as real-time monitoring and verification. High-efficiency filters and fan filter units continuously purify the air, creating a stable airflow and positive pressure environment to prevent external pollution from entering. A reasonable pressure difference and air flow direction design ensure uniform air flow and constant temperature and humidity, which is conducive to product quality and static electricity control. Meanwhile, cleanroom can always maintain a high-cleanliness environment that meets ISO or GMP standards, providing a reliable guarantee for high-standard production.
Cleanroom System Components
As a trusted cleanroom manufacturer, we specialize in providing cleanroom systems built from core components to maintain precise environmental control.
Air filtration system
It is the core of a cleanroom, used to remove tiny particles and microorganisms from the air. High-efficiency air filter and ultra-high-efficiency air filter can capture micron and sub-micron particles, ensuring that air cleanliness meets standards.
HVAC and air handling system
It is responsible for the air circulation, temperature and humidity control and differential pressure management in the cleanroom. It can achieve stable air flow and precise control of temperature and humidity, preventing external contamination from entering.
Fan filter unit
It is evenly arranged on the ceiling or top of the cleanroom, providing stable laminar or non-laminar airflow. Also, it can independently control the air volume, achieving uniform air distribution in all areas of the cleanroom.
Building envelope system
It is decorated with clean materials to reduce the accumulation of dust and microorganisms and make it easy to clean. The surface material should have low particle release, easy cleaning, anti-static and corrosion resistance properties, playing a significant role in air flow.
Air shower and pass-through window
The air shower is used for the initial purification of personnel before they enter the clean area, while the window is used for the dust-free transfer of materials to prevent cross-contamination caused by the entry and exit of items.
Monitoring and controlling system
Cleanroom relies on sophisticated monitoring and controlling systems to maintain a stable and contamination-free environment. They can continuously track key parameters such as air cleanliness, temperature, humidity.
Cleanroom Classification Standards
Our cleanroom can comply with international and industry standards to ensure a stable production environment, controllable cleanliness and meet regulatory requirements. The commonly used classification standards for cleanroom mainly include the following two categories:
ISO 14644-1 standard: This standard is an internationally recognized classification standard for air cleanliness levels in the cleanroom, which is classified into ISO Class 1 to 9 levels based on the allowable number of particles per cubic meter of air. The lower the value, the higher the cleanliness.
GMP standard: It is used for aseptic production and to define the air cleanliness and microbial control requirements of different areas.
Grade A: It is the key operation area with the highest cleanliness such as filling and sealing operation areas, where particle and microbial indicators are the strictest.
Grade B: It refers to the spatial background environment for Grade A level operations, ensuring clean and stable air in critical areas.
Grade C: It is medium and low-risk operation area with looser cleanliness requirements than the background environment.
Grade D: It is a low-risk operation area with relatively lenient cleanliness standards but air particles and microorganisms still need to be controlled.
Our Services for Cleanroom Manufacturing
CRM provides one-stop services from cleanroom design to construction, validation to maintenance to ensure that every cleanroom project is safe, efficient and in compliance with standards. Our six major service modules include:
Design
We deliver complete design solutions including CAD and BIM modeling, airflow calculations, pressure differentials and layout optimization. Customized designs are developed based on production requirements, product types and industry standards to achieve optimal cleanroom performance and efficiency.
Fabrication
It is carried out in our in-house factory, producing panels, fan filter units, cleanroom doors and windows and other components with strict quality control. Every component undergoes rigorous inspection to ensure low particle release, durability and compliance with ISO and GMP standards.
Installation and construction
We provide professional construction teams and turnkey project management from basic construction to full system installation. All work strictly follows design specifications and the contamination risks are controlled. Also, safety and project schedules are closely monitored.
Validation
This stage includes comprehensive cleanroom verification such as airflow measurement, pressure differential checks and temperature and humidity verification. These services ensure the cleanroom meets ISO, GMP or industrial requirements with detailed testing reports for compliance and regulatory approval.
Transportation and delivery
We carefully arrange transportation and delivery of the cleanroom, ensuring all components arrive safely and on schedule. After delivery, we inspect the cleanroom setup to confirm it is ready for installation and production requirements and then complete the final project handover to the customer.
Maintenance and upgrades
We offer regular maintenance, filter replacement, system calibration and overall upgrades. These services keep the cleanroom operating consistently within design standards and prevent performance decline due to aging or system changes. Tailored upgrade plans optimize efficiency and extend the lifespan of cleanroom.
Cleanroom Installation Cases
Why Choose Our Cleanroom Manufacturing Services?
As a leading cleanroom manufacturer, we have many years of experience in the design, manufacture, construction and validation of cleanroom and are familiar with international and industry standards such as ISO and GMP. Whether it is the pharmaceutical, electronic, medical device or food industry, we can provide clean solutions that meet strict standards. Also, we have our own factory and professional construction team, ensuring that every cleanroom component is of reliable quality and the construction is precise and efficient. Each project undergoes strict quality control and verification testing.
Moreover, based on the customer’s production process, product type and cleanliness level requirements, we tailor design plans and construction schedules to flexibly meet the needs of cleanrooms of different scales and uses. Regular maintenance, system upgrades, technical training and after-sales support are provided to ensure the long-term stable operation of the clean workshop. We not only deliver products but also help customers achieve an efficient and safe production environment.
Applications of Our Cleanroom
Semiconductor Manufacturing
Pharmaceutical Manufacturing
Food & Beverage Manufacturing
Medical Device Manufacturing
Battery Manufacturing
Biotechnology Manufacturing
Aerospace Defence Industry
Optics Manufacturing
Cosmetic Manufacturing
FAQ of Cleanroom
How often should a cleanroom be cleaned?
It usually depends on its cleanliness level and usage intensity. Daily basic cleaning of the floor and frequently touched areas should be carried out. Deeper cleaning of the walls, the outer surfaces of equipment and corners is required every week. Monthly cleaning usually covers a thorough cleaning of the ceilings and hard-to-reach areas.
Can I expand the cleanroom in the future?
Yes. A cleanroom can be expanded in the future. However, whether it can be expanded depends on the original structure, purification level and process requirements. If expansion space and flexible HVAC system interfaces are reserved in the initial design stage, it will be relatively easy to adjust the layout.
What is not allowed in a cleanroom?
In a cleanroom, it is not allowed to carry or use any items that may cause particle, microbial or chemical contamination such as uncleaned personal items, ordinary clothing, food, beverage, cosmetic. All personnel and items entering the cleanroom must undergo strict cleaning, disinfection and protective measures.
What is the most common source of contamination in a cleanroom?
The most common source of contamination in a cleanroom is the human personnel, including skin, hair, respiratory microorganisms and dust particles from clothing. Therefore, strict personnel management and protective measures are the key to maintaining a high level of cleanliness in a cleanroom.
How many people are allowed in a cleanroom?
There is no fixed standard for the number of people allowed to enter a cleanroom. It mainly depends on the grade of the cleanroom, the air handling capacity, the room area and the process requirements. The overall principle is to ensure that the air cleanliness, pressure difference and air flow organization remain within the compliant range under the given number of people.
How are cleanrooms classified?
It is mainly determined based on the concentration of particulate matter in the air and the requirements for microbial control. Internationally, the ISO14644 standard is commonly used to classify cleanrooms into class 1 to class 9. The GMP standards classify cleanrooms into four grades from A to D. The grade of a cleanroom is determined by a combination of parameters.
What products are commonly manufactured in a cleanroom?
A cleanroom is typically used for the production of products with extremely high requirements for environmental cleanliness, including pharmaceuticals and biological products, electronic and high-tech products and aerospace parts. Meanwhile, some foods, cosmetics and laboratory reagents with high cleanliness requirements are also often produced in a cleanroom.
What is the difference between positive and negative pressure in cleanrooms?
It lies in the relative level of the indoor air pressure to the external environment. The indoor pressure of a a positive pressure cleanroom is higher than that of the external environment, allowing air to flow out of the room. A negative pressure cleanroom is one where the indoor pressure is lower than that of the external environment, allowing air to flow in from the outside.