This guide contains everything you need to know about modular clean rooms and their uses.
You will learn:
A modular clean room is a pre-engineered space crafted to reduce and control the presence of sub-micron particles. These clean rooms are constructed using prefabricated panels that seamlessly fit into a framework. They can be acquired as a kit for easy self-assembly or professionally built by a skilled technician. Due to their simpler design and budget-friendly components, modular clean rooms are generally more economical than their traditional counterparts.
With their adaptable construction and swift setup, modular clean rooms can be rapidly assembled and operational, offering an excellent solution for urgent project needs.
There are primarily two categories of modular clean rooms, characterized by the types of walls they incorporate: hard and soft. Hard wall clean rooms utilize sturdy panels composed of materials like plastic, aluminum, gypsum, or wood. Conversely, soft wall clean rooms rely on walling systems made from various types of curtains, often plastic or vinyl.
Modular clean rooms are versatile, customizable enclosures engineered to establish controlled environments within any manufacturing or laboratory setting. By utilizing modular construction, clean rooms can be assembled quickly and retrofitted to existing spaces, ensuring regulated air quality, humidity, pressure, temperature, and particulate levels. These flexible cleanroom systems are vital for industries striving to meet stringent contamination control standards, ISO classifications, and GMP (Good Manufacturing Practices) guidelines. As standalone modular units, they deliver exceptionally clean conditions for processes such as product testing, quality control, assembly, packaging, and research.
The advanced design and precision engineering of modular clean rooms create isolated environments that shield sensitive equipment or processes from contaminants including dust, bacteria, microorganisms, airborne particulates, and temperature fluctuations. Modular cleanrooms are widely used in industries like pharmaceuticals, biotechnology, medical devices, microelectronics, semiconductors, aerospace, automotive manufacturing, food processing, and research laboratories. Their scalable, prefabricated architecture supports temporary, mobile, or permanent cleanroom solutions tailored to evolving production needs.
Because modular clean rooms are mobile and rapidly deployable, they play a critical role in emergency response, such as epidemic and pandemic testing. Portable cleanroom modules enable on-site medical diagnostics, sample processing, and biosafety operations in areas that lack permanent laboratory infrastructure. This capability is especially valuable in remote, rural, or improvised locations, ensuring resource-limited regions have access to reliable infection control and rapid contamination assessment during outbreaks or public health emergencies.
For companies experiencing rapid growth or requiring increased production capacity, modular clean rooms deliver a convenient and efficient solution for expanding existing laboratory spaces, manufacturing areas, or quality assurance zones. Their pre-engineered panels can be assembled and made operational in less than a day, minimizing downtime, disruption, and construction costs. This fast-track installation makes modular cleanrooms an ideal choice for facilities adapting to changing workflow requirements, scaling up for new product launches, or meeting elevated regulatory standards without lengthy build times.
Controlling hazardous waste is essential for workplace safety, environmental protection, and regulatory compliance. Modular clean rooms are specifically designed to be rapidly assembled as containment rooms or isolation chambers for safe handling, storage, and disposal of hazardous substances. Cleanroom technology ensures the effective capture of chemical fumes, particulates, and biological agents, mitigating the risks associated with spills, leaks, or cross-contamination. Modular containment rooms are an invaluable solution for industries requiring emergency decontamination, hazardous material remediation, or temporary quarantine spaces.
University professors and educational institutions often require specialized research chambers for student demonstrations and laboratory training. Modular clean rooms offer a flexible, budget-friendly solution for creating controlled environments within teaching labs or research facilities. These enclosed modular labs provide a safe, hands-on learning experience, helping students observe protocols for contamination control, sterile technique, and process validation.
For schools facing budget restrictions, modular cleanrooms present an economical alternative to conventional construction, expediting the approval process and reducing capital expenditure. They also support reconfiguration or relocation as program requirements evolve, contributing to long-term value and utility for STEM education, advanced research, and professional training curricula.
In many manufacturing and industrial environments, situations arise where parts or components demand advanced cleaning procedures exceeding standard protocols. Modular clean rooms serve as convenient, isolated spaces for thorough decontamination, precision cleaning, or final assembly under cleanroom-grade conditions. This is particularly relevant for manufacturers launching short-term projects, producing low-volume specialty items, or responding to unexpected contamination events. Modular deep cleaning rooms are outfitted with HEPA filtration, airlocks, and customizable layouts for maximum process control and operational flexibility.
Even companies that do not routinely operate a cleanroom benefit from the immediate availability and effectiveness of modular clean room rentals or temporary installations. These systems make compliance with customer or regulatory cleaning standards feasible and affordable, protecting product integrity and brand reputation.
Modular clean rooms are specifically engineered to maintain pollutant-free, ultra-clean air environments necessary for sensitive processes in laboratory, industrial, or high-tech production settings. Controlled conditions within modular cleanrooms virtually eliminate airborne dust, bacteria, volatile organic compounds (VOCs), and sub-micron particles that could otherwise jeopardize product quality or process yields. High-efficiency air filtration and positive pressure systems ensure cleanroom classifications range from ISO 5 to ISO 8, meeting customer and compliance requirements for clean manufacturing environments.
The quick installation and operational readiness of modular clean rooms make them indispensable for reducing downtime in critical applications such as semiconductor manufacturing, pharmaceutical preparation, and sterile packaging. By minimizing risk of environmental contamination, they help organizations maintain consistent quality management and audit-readiness.
From laboratory research to large-scale industrial processes, organizations that handle hazardous, corrosive, or volatile chemicals require an environment with strict contamination and exposure control. Modular clean rooms and softwall cleanroom enclosures provide a cost-effective alternative to permanent structures for chemical handling, chemical analysis, and sterile compounding. Their robust construction, customizable airflow management, and easy integration with fume hoods and safety systems ensure a reliable workspace for chemical storage, sample preparation, and quality testing while reducing operating expenses.
Certain industrial assembly operations—including electronics assembly, optics, aerospace components, and food packaging—mandate an uncontaminated, environmentally controlled workspace to ensure proper function and compliance with quality standards. While not all processes require the highest ISO cleanroom standards, modular clean rooms deliver configurable environmental controls, antistatic properties, and flexible floorplans that can be engineered around a specific assembly line or workstation. This adaptability supports just-in-time production, minimizes material handling risks, and allows for easy reconfiguration to support future process changes.
Precision machining applications, such as those involving CNC (Computer Numerical Control) machines, require stringent environmental management to prevent costly production errors, equipment failures, or contamination-related defects. Modular CNC clean rooms are designed to enclose milling equipment, lathes, and routers, shielding them from dust, particulate, temperature changes, and vibration. This protective enclosure not only extends machine life but also ensures higher product yields and repeatability in high-tolerance manufacturing operations.
Modular clean room enclosures for CNC operations are available in a range of ISO classes and can be engineered with sound attenuation, superior temperature control, and easy integration with material handling automation. Whether retrofitting existing facilities or incorporating cleanroom zones into new builds, modular CNC enclosures deliver cost savings, operational efficiency, and improved compliance.
Beyond the specific uses outlined above, modular clean rooms are increasingly being adopted in emerging fields such as nanotechnology, regenerative medicine, 3D printing, and battery manufacturing. Their inherent flexibility, energy efficiency, and compliance with cleanroom standards (including ISO 14644 and USP 797/800) position them as a smart investment for organizations seeking to scale operations, secure grant funding, or accelerate go-to-market timelines. The ability to rent, lease, or purchase modular clean room systems adds further flexibility, making them a preferred choice for R&D startups, contract manufacturers, and companies exploring new product development.
When selecting a modular clean room provider, consider factors such as cleanroom certification, modular wall system specifications, airflow design (laminar or turbulent), seamless integration with existing HVAC, and aftersales technical support. Leading cleanroom suppliers often offer turnkey installation, staff training, and maintenance services to ensure regulatory compliance and uninterrupted operations.
Modular clean rooms come in various types, each tailored to the specific needs of the industry they serve. Like traditional clean rooms, modular clean rooms are designed with robustness and ease of installation, making them an adaptable solution for several rapidly growing sectors.
The classification of a clean room depends on its air quality, which is assessed based on the presence of aerosol particles, airborne microbes, dust, and chemical vapors. Each modular clean room undergoes rigorous testing and grading to determine its classification.
The design and specifications of a modular clean room are guided by production, manufacturing, and assembly requirements, which dictate the necessary cleanliness standards. The choice of components, materials, surfaces, and interior features is established prior to assembly, and these design specifications are meticulously adhered to during construction.
Most modular clean rooms in use today are of the softwall type, characterized by their flexible walls and smaller size compared to traditional hardwall clean rooms. Softwall clean rooms offer a cost-effective solution when space and mobility are key considerations.
Softwall clean rooms are often described using terms such as prefabricated, portable, and tent-like. They share common attributes: affordability, ease of installation, and the ability to be quickly expanded.
In situations where additional isolation is needed within a hardwall clean room, softwall clean rooms can be an ideal solution due to their ease of setup and immediate usability.
These clean rooms typically come in standard sizes ranging from 8’x8� to 12’x24�, with ISO classifications from Class 6 to Class 8. However, manufacturers can customize sizes and designs to meet specific requirements.
Softwall clean rooms are the most budget-friendly option among modular clean rooms. Constructed with a metal frame and transparent panels or curtains, they include HEPA filters and ceiling lights. Air is circulated downward through the clean room, removing unwanted particles and protecting sensitive equipment and processes.
These clean rooms can be integrated into existing spaces, built as standalone structures, or suspended from ceilings. They are commonly used in the medical and pharmaceutical industries, as well as in manufacturing sectors that require high precision, such as aerospace and semiconductor industries.
CMM clean rooms are specifically designed to create a controlled environment for Coordinate Measuring Machines (CMMs), which measure X, Y, and Z axis coordinates with high precision. These rooms are equipped with sound and temperature controls, as well as safeguards against fire and potential damage to the measuring equipment. The primary purpose of CMM clean rooms is to ensure that manufacturing and assembly processes meet design specifications by providing accurate and reliable data on X, Y, and Z coordinates.
Nanotechnology clean rooms are essential for industries such as semiconductor manufacturing, medical instrument production, and pharmaceuticals. These clean rooms provide a highly controlled environment that is free from particles, gases, and contaminants, which is crucial for maintaining the integrity and quality of nanoscale components and products.
High bay modular clean rooms are specifically engineered for the aerospace industry. These clean rooms adhere to the same rigorous standards as other clean rooms but feature exceptionally high ceilings and custom-designed walls tailored to meet industry-specific requirements.
Grow and cultivation clean rooms are specifically designed for hybrid pollination and to maintain precise temperature and humidity conditions for plant incubation. These clean rooms feature insulated walls to create a thermal barrier that protects against external environmental factors.
Essential features of grow and cultivation chambers include protection against outgassing and microorganisms, which can hinder plant growth and damage delicate crops. To accommodate the movement of plants and equipment, these clean rooms often include large entryways.
The purpose of coating clean rooms is to prevent contamination of the coating materials by external substances. By isolating the coating process in a controlled environment, these clean rooms ensure that unwanted materials do not interfere with the application.
Additionally, coating clean rooms are crucial for safety because some coating materials contain flammable chemicals. The enclosed environment of a clean room minimizes the risk of combustion and provides a safer workspace for both the operation and the employees.
The process of coating in a clean room can have a through wall opening that allows a conveying system to enter the enclosure.
Airborne particles, humidity, and temperature fluctuations can damage products during production and compromise their quality. To maintain high standards, manufacturers use modular clean rooms to create a controlled, protected, and exceptionally clean environment for production.
Machine clean rooms are designed to shield equipment from factors that could lead to rejection during final inspection. Incorporating a modular clean room into the production process can significantly reduce waste, increase profitability, and prevent cross-contamination between equipment.
Aseptic modular clean rooms are designed to be completely free from contaminants, making them ideal for life sciences, biomedical, and medical device industries. Their interiors are seamless, durable, and non-shedding, allowing them to withstand frequent cleaning and sterilization. The primary goal of aseptic clean rooms is to prevent the buildup of contaminants and bacteria, ensuring a sterile environment.
Hardwall modular clean rooms feature solid wall panels made from various materials. Unlike softwall clean rooms, these are supported by their walls, with a ceiling grid and roof, offering a more permanent structure. Although they closely resemble traditional clean rooms, their components can be easily replaced.
Designed to provide an extra layer of protection, hardwall clean rooms are ideal for testing and research environments where precise control of temperature and humidity is critical. They offer impact resistance, easy maintenance, excellent lighting, and allow for external staff oversight, ensuring the workspace remains free from airborne contaminants.
Constructing a modular clean room starts with selecting the appropriate components, including materials for the frame, walls, ceiling, floor, and air filtration system. The choice of materials is based on the required clean room classification. To achieve a higher classification, the clean room must be built with high-quality materials and components that meet stringent standards.
Choosing the appropriate materials for a clean room starts with deciding between solid or fabric walls. Each type offers various options that can be customized to suit specific manufacturing or testing needs.
PVC panels are known for their durability and excellent barrier properties against external contaminants. They are resistant to chemicals, solvents, and fluids, making them suitable for use as total enclosures or entrance coverings in modular clean rooms.
PETg is a thermoplastic known for its high chemical resistance and exceptional durability. Unlike other plastics, PETg is transparent, allowing for easy observation of procedures from outside the enclosure.
In modular clean room construction, PETg is primarily used for observation windows and wall panels, providing both visibility and robust performance.
Common categories of modular clean room panels include:
In modular clean rooms with steel construction, the corners and ceiling are welded for durability. To enhance cleanliness, the steel is often finished with a powder coating. The wall panels in such clean rooms can be made from various materials, depending on the specific requirements of the environment.
The frames for aluminum modular clean rooms are made from extruded anodized aluminum. This material offers flexibility, allowing the frames to fit into challenging spaces. Aluminum's lightweight nature and versatility enable it to be shaped and customized to any dimension, making installation straightforward and adaptable.
The construction of a modular clean room starts with selecting the wall materials, which is crucial for determining the room's cleanliness and maintenance ease. Various materials are available, each affecting the room's hygiene and cleaning requirements.
One of the benefits of modular clean rooms is the ability to move, shift, and reposition walls to accommodate specific testing needs. A key consideration in choosing clean room walls is their ease of cleaning and ability to meet required sanitary standards. For instance, aseptic environments require walls that can be exceptionally cleaned to maintain high levels of cleanliness.
The floor of a modular clean room, like the walls, significantly impacts the room’s classification. It must be durable enough to endure frequent cleanings with various solvents and cleaners.
Common types of modular clean room flooring include:
Perforated raised flooring is designed to allow for contaminants and particulates to be removed from the room by the air circulation system as well as manage the heat load. The use of a perforated raised floor creates a more efficient environment for the air flow system.
There are several factors that govern a modular clean room ceiling since they must be capable of supporting a variety of equipment, which includes the lighting, air flow system, sprinklers, and various forms of small equipment. Ceilings for modular clean rooms consist of suspended panels that are locked or bolted together.
The ceiling material of a modular clean room is designed to be flexible and adjustable, accommodating the installation of venting, lighting, and filters without requiring changes to the orientation of the panels. The flush, smooth bottom surface allows for ceiling components to be installed anywhere without interfering with the grid.
A key feature of ceiling panels is their precise fit, with each panel securely connected to its adjoining panel using a fixed metal spline. Non-progressive ceiling panels are designed for easy disengagement, allowing for adjustments and removal as needed.
Ceilings are constructed from large sheets that are treated and cut into tiles. To ensure a tight seal, gaskets or other sealing methods may be used. During installation, the tiles are fitted closely to prevent ambient air from entering the clean room.
Just like other factors affecting a modular clean room, the choice of lighting plays a crucial role in the room's working conditions and overall operation. Lighting options include incandescent, fluorescent, and LED. In modular clean rooms, careful consideration must be given to how lighting is integrated, unlike in permanent clean rooms.
Lighting placement must be coordinated with the air supply system to minimize contamination. As the air supply system is installed in the ceiling, lighting fixtures need to be positioned around it to avoid interference.
Cost is an important consideration for the lighting system, as it impacts both the initial installation and ongoing energy expenses. Additionally, maintenance costs are a factor, since keeping light fixtures free of contaminants is essential. Clean room operations often involve precision instruments, which require high foot candle levels to ensure adequate illumination.
Types of lighting include:
The air filtration system is the most crucial component of a modular clean room, responsible for circulating highly purified air with minimal contaminant particulates. To maintain such stringent conditions, clean rooms utilize high-efficiency particulate air (HEPA) filters, which can remove 99.95% of airborne particles.
All the air that enters a clean room passes through one or more HEPA filters. For clean rooms that require greater efficiency, ultra-low particulate air (ULPA) filters are used that capture particles as small as 0.12 microns, which is one millionth of a meter.
In modular clean rooms, filtered air is introduced from overhead fans and exits through the floor or floor vents. In single-pass systems, air is drawn in through the ceiling and expelled outside. Conversely, recirculating clean rooms pull exhaust air back through the filtration system to be cleaned and reintroduced. A negative pressure design helps prevent contaminants from escaping the clean room and affecting external areas.
Laminar airflow systems utilize laminar hoods to maintain a steady, unidirectional airflow. These hoods direct air downward into the room and are constructed from non-shedding metals to avoid introducing contaminants. Laminar airflow systems are integral to the clean room's overall filtration setup.
Various features can be incorporated into a modular clean room to enhance control over contaminants and harmful particulates.
Pass Through Chambers � To avoid the need for workers to be constantly dressing and undressing to enter a modular clean room, pass through chambers are added that allow people outside the chamber to pass items to people on the inside. These are tightly sealed and only remain open for an instant.
Gowning Room � Though this may be listed as an extra component, gowning rooms are a common part of the clean room process since anyone who enters a clean room has to be properly covered and cannot get covered in the clean room. The gowning room is a controlled space for workers to put on their clean room gear.
Air Showers � An advanced and technologically innovative addition to modular clean rooms is an air shower, which is normally added to the airlock system. When a worker enters the air lock, a burst of filter air is blown at the employee to remove any potential contaminants that can be shaken off by a burst of air.
An essential aspect of clean rooms is the provision of a pollutant free environment with a low possibility of contaminants. All equipment, cleaning products, utensils, clothing, and any other materials must meet specific standards to keep the clean room’s ISO classification. To ensure a clean room is up to standards, there are certain tests that are performed to determine the effectiveness of the air handling unit and the seal of the room.
Clean rooms are designed to perform sensitive material testing with exceptionally low levels of pollutants. Such conditions are crucial for specific manufacturing, pharmaceutical, and scientific research needs. Despite being mobile, modular clean rooms must still adhere to ISO standards. Testing these clean rooms involves engineering simulations to ensure they meet the required specifications.
Computational Fluid Dynamics (CFD) is a technique for mathematically modeling fluid flow and related physical phenomena. Building and testing a physical prototype of a clean room can be costly and time-consuming. Instead, engineers use CFD to simulate and analyze the clean room's components without needing the actual product.
CFD analysis involves studying fluid flow based on physical properties such as velocity, pressure, temperature, density, and viscosity—all of which are crucial for clean room performance. CFD software allows for the simultaneous examination of these factors to produce accurate data about the clean room's behavior and effectiveness.
Key aspects analyzed by CFD software for clean rooms include:
– Air Change Effectiveness: This simulation assesses the circulation patterns of air within the clean room and identifies areas that may be challenging to ventilate effectively.
– Contaminant Distribution: CFD analysis predicts how contaminants will disperse within a clean room and allows for tracking their movement. This data helps in forecasting potential risks to materials and personnel.
– Air Flow Efficiency: Proper air flow is crucial in clean room design as it can lead to significant issues if not managed correctly. CFD software helps identify air flow velocity, allowing engineers to adjust the room’s design to ensure uniform air distribution throughout the space.
Another important method for testing air flow in a clean room is through smoke studies, which help visualize airflow patterns. By introducing smoke into the clean room, its movement reveals the air flow dynamics. Smoke studies, also known as dynamic air visualization, are crucial for the qualification, maintenance, and ongoing monitoring of a clean room to ensure it remains free from contamination.
Smoke studies confirm that the air flow is properly directed through the high-efficiency particulate air (HEPA) or Ultra Low Particulate Air (ULPA) filters. Expertly trained professionals carefully select the type of smoke used in the test, as the physical properties of the smoke significantly impact the study results and the clean room’s qualification.
The specialized capabilities of clean rooms have made them indispensable across various industries, as they offer conditions that are otherwise unattainable in typical production settings. With the growing demand for intricate and precise electrical components, modular clean rooms have become crucial in numerous industrial processes.
As modern manufacturing increasingly focuses on product quality and longevity, testing in an uncontaminated environment is essential for accurate assessment. Clean rooms play a pivotal role in this by providing a controlled setting that ensures precise and reliable data on a product's strengths and weaknesses.
In the aerospace industry, the precision of equipment production is paramount, and components must be free from contaminants and particulates. Clean rooms are essential for achieving this level of cleanliness, as even the smallest flaw or weakness in sensitive instruments can lead to serious risks and significant losses.
Minor imperfections such as paint specks, deformities, or contamination can lead to equipment failures. To address these challenges, modular clean rooms for aerospace are custom-designed and assembled to meet the specific requirements of manufacturers.
The automotive industry relies heavily on modular clean rooms throughout the entire production process. From initial design to final product, clean rooms are used to test and validate prototypes, ensuring their viability.
As automotive technology advances and components become increasingly complex, clean rooms are employed at every stage of the supply chain. Similar to the aerospace sector, even minor flaws or contaminants can lead to component failures, making clean rooms crucial for maintaining quality and reliability.
The pharmaceutical industry, governed by stringent regulations and health standards, is a major user of clean rooms. The industry’s focus on preventing bacterial contamination drives rigorous measures to ensure that every drug and medication is sterile and free from production-related defects.
Each stage of production is conducted in specialized environments tailored to maintain cleanliness and sterility. Adherence to strict governmental regulations mandates regular inspections and compliance with established standards, underscoring the critical role of clean rooms in pharmaceutical manufacturing.
Medical instruments that come into contact with the body must adhere to stringent standards of sterility and cleanliness. Many of these devices, including implants and surgical tools, require manufacturing in environments with extremely low levels of dust, airborne microbes, aerosol particles, and chemical vapors.
Medical modular clean rooms serve as controlled laboratories essential for the production and research of medical instruments. These clean rooms are critical in ensuring both patient and product safety. Medical device manufacturers rely on clean room technology to eliminate airborne particulates and maintain an antimicrobial environment.
Errors in medical clean rooms can lead to severe, life-threatening consequences. Therefore, manufacturers of medical instruments and equipment depend on the rigorous standards of clean rooms to safeguard both their products and public health.
While dairy products can be contaminated like other products, the clean room requirements for dairy are generally less stringent compared to those for pharmaceuticals, medical devices, and electronics. Regulations for dairy manufacturing can vary based on the specific product being produced.
For example, the clean room standards for milk are less rigorous than those for yogurt, where bacterial activity is integral to the production process. Despite these differences, dairy clean rooms still focus on preventing contamination by bacteria, yeast, and mold. The design of dairy clean rooms emphasizes maintaining clean and contaminant-free air in the production area.
The production of e-cigarettes requires clean rooms that adhere to standards similar to those for medical and pharmaceutical products. The primary concern is chemical vapors that could contaminate the products and pose safety risks. To address this, clean rooms for e-cigarettes must comply with stringent International Organization for Standardization (ISO) requirements, ensuring minimal contamination.
E-cigarette manufacturers are obligated to meet at least Class 7 clean room standards, which means that particulates must not exceed 0.5 microns in size.
Modular clean rooms offer a cost-effective and adaptable solution for the electronics industry compared to traditional clean rooms. Their design allows for easy expansion and modification based on production needs.
These clean rooms can be adjusted, stored, and relocated, making them a versatile asset. Components can be disassembled and repurposed in different locations, providing flexibility at minimal expense.
In the electronics industry, modular clean rooms help maintain product stability and performance by ensuring a contaminant-free environment. The manufacturing space must be exceptionally clean and clear to meet industry standards.
Precision engineering involves designing machines, fixtures, and structures with extremely high tolerances that must remain stable over time. The sensitive nature of these parts necessitates a controlled and secure environment to meet the demands of precision engineering.
Modular clean rooms for precision engineering are designed to be ultra-clean and self-contained, providing maximum protection from pollutants and pathogens. Maintaining these conditions ensures that manufacturing, testing, and production of minute components proceed without issues. Even the smallest contamination can significantly impact product success.
While some printing processes involve large machines that use ink as part of the printing medium, artistic and delicate printing methods, such as screen and digital (computer-assisted) printing, require greater precision and controlled conditions.
For these sensitive and intricate printing processes, even the smallest amount of dust, speck, or air disturbance can damage or ruin a workpiece. To prevent such issues, screen and digital printers utilize clean rooms to maintain controlled conditions and ensure a uniform environment.
The primary organization for clean room classification is the International Organization for Standardization (ISO), founded in 1947. ISO's mission is to publish international standards for scientific research and various industrial practices.
Although ISO membership is voluntary, its standards serve as the foundational guidelines for industries using clean rooms. Since its inception, ISO has published over 20,000 standards covering topics such as chemicals, volatile materials, and sensitive instrument testing.
Clean room classifications are based on the level of cleanliness, measured by the size and quantity of particulates in a cubic volume of air. ISO classifications range from ISO 1, the strictest, to ISO 9, the least clean. Most clean rooms fall between ISO 7 and ISO 8.
While ISO is the most widely recognized clean room classification system, the U.S. previously used the Federal Standards 209 (FS209E) system. Although FS209E has been replaced by ISO standards, it is still used by some producers. FS209E has six classes, with Class 1 being the cleanest and Class 100,000 being the dirtiest. In the ISO system, FS209E Class 1 corresponds to ISO Class 3, and FS209E Class 100,000 corresponds to ISO Class 8.
Comparative charts for the two systems are provided below.
| ISO Cleanroom Classifications | |||||||
|---|---|---|---|---|---|---|---|
| ISO 14644-1 and ISO 14698 | |||||||
| Class | maximum particles/m3 | FED STD 209E equivalent |
|||||
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥1 μm | ≥5 μm | ||
| ISO 1 | 10b | d | d | d | d | • | |
| ISO 2 | 100 | 24b | 10b | d | d | • | |
| ISO 3 | 1,000 | 237 | 102 | 35b | d | • | Class 1 |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83b | • | Class 10 |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | d,e,f | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | ⁃ | ⁃ | ⁃ | 352,000 | 83,200 | 2,930 | Class 10,000 |
| ISO 8 | ⁃ | ⁃ | ⁃ | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
| ISO 9 | < | < | < | 35,200,000 | 8,320,000 | 293,000 | Room air |
| US FED STD 209E | ||||||
|---|---|---|---|---|---|---|
| Class | Maximum particles/ft³ | ISO | ||||
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥5 μm | Equivalent | |
| 1 | 35 | 75 | 3 | 1 | 0.007 | ISO 3 |
| 10 | 350 | 75 | 30 | 10 | 0.07 | ISO 4 |
| 100 | 3500 | 750 | 300 | 100 | 0.7 | ISO 5 |
| 1000 | 35000 | 7500 | 3000 | 1000 | 7 | ISO 6 |
| 10000 | 350000 | 75000 | 30000 | 10000 | 70 | ISO 7 |
| 100000 | 3.5x108 | 750000 | 300000 | 100000 | 700 | ISO 8 |
In addition to the ISO and FS209E classification systems, the United Kingdom and the European Union have their own set of standards. Despite the variety of classification systems available, the ISO system is widely adopted globally and serves as the primary guideline for clean room classifications across most countries and manufacturers.
Even if a cleanroom initially meets the required standards, it can quickly lose its classification if the air filtration system is inadequate. The performance of this system is heavily influenced by the number of filters used and the efficiency of the airflow. Regular inspections are conducted to ensure that modular clean rooms continue to meet compliance and maintain their classification.
The effectiveness of a clean room’s classification largely depends on its filtration system, which is a critical component. The type and number of filters used significantly affect particulate levels and overall clean room performance. To ensure continued compliance, modular clean rooms adhere to a strict maintenance schedule that includes regular checks and replacements of HEPA or ULPA filters.
While equipment and filters are crucial, the biggest challenge often comes from human factors. Despite the best systems and practices, contamination frequently arises from the individuals working in the clean room. Manufacturers closely monitor and manage personnel practices to maintain the integrity and cleanliness of the environment.
The demand for sterile environments has surged with advancements in technology, necessitating controlled and monitored conditions for the production of sophisticated instruments. While traditional clean rooms are crucial for handling sensitive materials, their permanent installation can be costly and may not be necessary for all scenarios.
Modular clean rooms offer a practical solution by bridging the gap between permanent clean rooms, which require extensive structural modifications, and temporary setups like plastic tents. These modular systems can be quickly and easily installed with minimal disruption, making them ideal for temporary or short-term applications where long-term commitment is not required.
The primary appeal of modular clean rooms lies in their rapid setup and construction. The installation process starts with a durable frame that supports prefabricated and custom-designed panels, allowing the clean room to be assembled in just a few hours. This efficiency means that a team can quickly access a controlled and monitored environment to start their projects. Equally impressive is the ease of dismantling: the clean room can be removed just as swiftly, leaving no trace of its presence.
Cost is often the primary concern when considering changes to manufacturing or testing processes. Typically, these adjustments involve significant mechanical and operational modifications that can be costly, require extensive planning, and disrupt workflow. In contrast, modular clean rooms offer a cost-effective solution. They are efficient, compact, and affordable to install and operate, avoiding the major expenses and disruptions associated with more permanent changes.
Maintaining equipment to ensure optimal performance can be costly and complex. For traditional brick-and-mortar clean rooms, any damage or issues typically require a shutdown for repairs and reclassification, which can be both time-consuming and disruptive.
In contrast, modular clean rooms offer a more flexible solution. If a component is damaged, it can be swiftly removed and replaced with minimal disruption to operations. Modular clean rooms feature moisture control, air filtration, and durable components that are easily replaceable and adaptable, ensuring continued efficiency and performance.
Manufacturers are increasingly focused on minimizing their environmental impact by implementing sustainable practices and policies. Modular clean rooms align with this goal by being fully reusable and adaptable. Each component of a modular clean room can be employed, removed, and repurposed without the need for new construction. Once installed, a modular clean room operates as an isolated environment, leaving no footprint on its surroundings.
When a modular clean room is no longer required, it can be dismantled and removed completely, leaving no trace of its previous presence.
While cost, construction, maintenance, and environmental impact are important factors in choosing a modular clean room, the primary benefit lies in its ability to create a controlled, contamination-free environment for observing, testing, and studying sensitive materials. Modular clean rooms start with a HEPA filtration system to maintain air purity. Their flexibility allows them to be easily adapted, modified, and reconfigured to meet evolving needs and conditions.
Labeling a modular structure as a clean room implies that it meets specific standards and certifications, including ISO certification, FDA approval, and EU regulations. Manufacturers of modular clean rooms strive to ensure their products comply with the stringent requirements set by major certification bodies. Maintaining the integrity of these standards is crucial, as the term "clean room" is reserved for environments that adhere to rigorous codes of cleanliness and operational precision.
Permanent buildings added to a facility depreciate over time, with their cost typically amortized over forty years. In contrast, modular clean rooms qualify for accelerated depreciation under IRS Section 179, allowing companies to amortize their cost over just six to seven years. This provides a significant tax advantage compared to permanent clean rooms, which spread their depreciation value over forty years. Despite offering comparable capabilities, modular clean rooms offer a more favorable depreciation schedule, making them a cost-effective choice for companies.
A cleanroom is a specially designed enclosed space where airborne particulates have been limited or removed by a highly sophisticated filtration system. They are used by industries that require a highly controlled and monitored environment for the production...
Cleanroom products are specially designed and engineered to prevent the contamination and pollution of highly sensitive cleanroom environments. For a cleanroom to receive its level of classification, it is required to be cleaned, constructed, and sanitized to meet a list of qualifying conditions and standards....
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A softwall cleanroom is a confined controlled space with a metal frame, clear panel walls, an entrance, high efficiency particulate air (HEPA) filters, and exceptional lighting that is designed to provide a contaminant and particulate matter free workspace...
A cleanroom is a specially designed and configured room that has been constructed to eliminate dust particulates and atmospheric contaminants. They are commonly used for scientific research, pharmaceutical production, and other industries that produce products that can be damaged by unsanitary or polluted conditions...
An altitude chamber is a test chamber that is designed to simulate the altitude, vacuum, and temperature of environmental conditions at heights that match the flight patterns of all forms of aircraft, from commercial to military...
A climate chamber is an enclosed space that provides a controlled set of circumstances for testing the impact of various environmental and climatic conditions on industrial goods, commercial products, electronic devices, materials, and biological matter...
A cold room is a temperature controlled environment that is capable, through refrigeration, to create conditions for storage, experimentation, and preservation of foods, equipment, and medical supplies. The types of cold rooms are...
An environmental chamber is an enclosure used to test the effects of a variety of conditions on a product, component, part, or assembly. These highly technical pieces of equipment are capable of simulating the types of conditions a product may face while in use...
A HEPA filter is a high efficiency pleated air filter capable of capturing extremely small particulate matter down to particles that are the size of a micron (µ), or a micrometer, which is 1/1000th of a meter...
A humidity chamber is a mechanism that examines how products react when exposed to variations in humidity. This type of environmental testing is used by manufacturers to test the various parameters of their products in the harshest of conditions...
Modular buildings are buildings made up of standardized sections, called "modules," manufactured in a controlled environment of a factory away from the building's future location. The common factory-made, standard modules include walls...
A portable office is a mobile workspace that can be easily assembled and placed to provide a quiet and convenient location for meetings, completing paperwork, or examining plans. They are built using...
Prefabricated buildings, or prefabs, are buildings with components (walls, roof, and floor) that are manufactured in a factory or manufacturing plant. These components can be fully or partially assembled in a factory which is then transferred at the construction site...
Stability chambers and rooms are climate-controlled environments that provide stable conditions for testing and storage. These specialized environmental chambers offer a precise, raised temperature or humidity to ascertain whether a...
A temperature chamber is a controlled environment capable of producing conditions that a product will encounter during its use. These highly controlled technical tools are able to produce the types of hazards, uses, and atmospheres a product may endure...
A test chamber is a managed and controlled environment used to test the endurance, stability, and practicality of equipment, products, and chemicals. They are a controlled enclosure that mimics the effects of environmental conditions that a product may encounter during its usage...
Thermal shock chambers are climatic chambers for thermal shock testing that are utilized to put the material to serious shocks. This is accomplished through the repeated and sudden passage to low temperature areas from...
A vacuum chamber removes air and pressure from a confined enclosure to test the effects of a vacuum on parts, materials, components, and assemblies. It can also be used to test the performance of applications for manufacturing operations...
The purpose of an environmental testing chamber is to examine the effects of a variety of climactic, physical, and other unique conditions on a product. They are designed to create environments that a product may encounter during its use...