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Introduction
This guide contains everything you need to know about modular clean rooms and their uses.
You will learn:
What is a Modular Clean Room?
How Modular Clean Rooms are Used
Industries that Use Modular Clean Rooms
The Standards for Modular Clean Rooms
And much more ….
Chapter One – What is a Modular Clean Room?
A modular clean room is a prefabricated environment designed to control and minimize the presence of sub-micron particulates. Constructed from pre-made panels that fit into a framework, these clean rooms can be purchased as a kit for self-assembly or built by a technician. Their straightforward design and cost-effective components make modular clean rooms more affordable compared to traditional clean rooms.
Offering flexible design and rapid assembly, modular clean rooms can be quickly installed and put into use, making them ideal for immediate project processing needs.
Modular clean rooms come in two main forms, distinguished by the type of walls used in their construction: hard or soft. Hard wall clean rooms feature solid panels made from materials such as plastic, aluminum, gypsum, or wood. In contrast, soft wall clean rooms use various types of curtains, including plastic or vinyl, for their walls.
Chapter Two – What are the uses for modular clean rooms?
Modular clean rooms can be installed in any manufacturing environment to ensure controlled, uncontaminated conditions for product and equipment testing. As standalone units, they offer exceptionally clean conditions for a range of processes and functions.
The design and engineering of modular clean rooms create environments that isolate equipment or processes from contaminants such as dirt, dust, air, and temperature fluctuations. They are widely used in industries like pharmaceuticals, biotechnology, medical devices, and microelectronics.
Uses for Modular Clean Rooms
Epidemic Testing
Because modular clean rooms are mobile, they can be rapidly deployed to areas experiencing an epidemic for on-site testing. This capability is particularly valuable in remote or isolated regions lacking adequate medical facilities.
Expansion
For companies experiencing rapid growth, modular clean rooms offer a convenient and efficient solution for expanding testing facilities. They can be assembled and operational in less than a day, providing additional workspace at a low cost. This makes modular clean rooms an ideal choice for quickly adapting to increased demands.
Hazardous Waste
Modular clean rooms are perfect for managing hazardous waste in environments lacking adequate control measures. They can be quickly assembled to handle and contain hazardous materials, providing an effective solution for immediate waste management needs.
Educational Research
University professors in need of a research chamber for student demonstrations can benefit from modular clean rooms due to their cost-effectiveness and flexibility. These enclosed, controlled environments allow for practical, hands-on learning experiences while ensuring safety.
Modular clean rooms address the financial constraints often faced by educational institutions. They offer a more feasible alternative to constructing new facilities, making it easier to secure approval from governing boards for their purchase.
Deep Cleaning
In manufacturing, there are times when a part or component requires a more thorough cleaning than the standard procedures allow. This is particularly relevant for companies that do not typically use clean rooms, making a modular clean room an ideal solution.
Such instances may arise due to the need for enhanced cleaning, similar to requirements for handling hazardous materials. While not a regular occurrence for all manufacturers, these situations demand immediate and effective action.
Pollutant Free Environment
Modular clean rooms are designed to create environments where pollutants and contaminants are minimized, and the air is free of bacteria. These controlled conditions are essential for removing harmful air particulates that could contaminate the surrounding environment.
One of the key advantages of modular clean rooms is their ability to be quickly set up and put into operation, effectively limiting the release of contaminants.
Chemicals
When handling volatile substances, manufacturers need a controlled and closely monitored clean space. While permanent clean rooms are an option, modular clean rooms offer a more cost-effective and economical solution to achieve the required conditions.
Assembly Processes
Some assembly operations need an uncontaminated environment, though not necessarily the strictest protocols. Modular clean rooms provide an adaptable solution by offering environmentally controlled conditions that can be assembled around a production line, ensuring a secure and controlled workspace.
CNC
CNC clean rooms offer a controlled environment for CNC machines, shielding them from harmful debris and contamination. This protection helps prevent production rejections and reduces overall costs. Modular clean rooms can be installed around existing equipment or integrated into new constructions.
A CNC clean room enclosure provides a thermal barrier for effective temperature control, reduces external noise, and is available in various designs and configurations to suit different needs.
Leading Manufacturers and Suppliers
Chapter Three – What are the different types of modular clean rooms?
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.
Coordinated Measuring Machines (CMM Clean Rooms)
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
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
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
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.
Coating Clean Rooms
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.
Machine Clean Rooms
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 Clean Rooms
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
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.
Chapter Four – How Modular Clean Rooms are Made?
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.
Modular Clean Room Materials
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.
Types of Panels
PVC Panels
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.
Polyethylene Terephthalate Glycol (PETg)
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.
Other types of Panels
Common categories of modular clean room panels include:
Rigidwall - rigid wall panels are similar to hard wall panels but are less expensive and made of clear flat material.
Types of Frames
Steel Frame
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.
Aluminum Frame
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.
Modular Clean Room Construction
Clean Room Walls
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.
Clean Room Floor
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.
Seamless vinyl flooring is a cost effective solution for modular clean rooms where there isn‘t a requirement for weight load. It can be either static dissipative or conductive resistant and comes in tiles or sheets. The sheet form is extended up the wall to form the coving. The type of seamless flooring used is commercial grade and wax less for ease of cleaning. It significantly reduces the ability for contaminants and particulates to collect in the seams of the floor.
Epoxy paint on concrete creates an easy to clean surface that is scuff resistant and has a smooth even light texture. It has aesthetic appeal as well as offering excellent protection. For this form of flooring method to work, the concrete substrate has to be in perfect and exceptional condition with minimal spalling or cracking. A major benefit of epoxy paint is that it can be cleaned and sterilized but still have excellent durability.
Rubber flooring has extraordinary wear resistance, has static dissipative grounding, is highly durable, and is cost effective as well as easy to maintain. It is installed in sheets and cold welded. Rubber flooring is designed for heavy wear and comes in several colors. Designers enjoy including rubber flooring because it meets many operational requirements.
Ceiling
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.
Lighting
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:
Panels – Light panels come in LED and fluorescent types. They are dust, corrosion, and water resistant. Since light panels fit seamlessly and tightly into the structure of the room, they prevent contaminants and dust from entering.
Strips – Light strips come with LED lights and meet the airflow requirements of a modular clean room. When installed, they follow the ceiling grid and are out of the way of the filtration system preventing them from blocking the airflow.
Teardrop – Unlike light panels and light strips, teardrop lights hang from the ceiling. Their placement allows for easy airflow around them. They are primarily used due to their affordability.
Air Flow Through – Air flow through lights are directly connected to the filtration system. They allow air to pass over and around them and do not block circulation. This form of lighting is designed for full coverage filter systems where there is limited space for light fixtures.
Filtration System and Air Circulation
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.
Additional Components
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.
Air Locks – The obvious main concern for modular clean rooms is the prevention of contamination, which can be caused by workers entering and leaving. To control this from happening, air lock systems can be attached to the clean room, which is a passageway that people go through before being allowed to enter.
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.
Chapter Five -How is testing conducted for modular clean rooms?
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.
Testing of Modular Cleanrooms
Computational Fluid Dynamics (CFD)
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.
Smoke Studies
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.
Chapter Six – Which industries use modular clean rooms?
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.
Industries That Use Modular Clean Rooms
Aerospace
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.
Automotive
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.
Pharmaceutical
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
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.
Dairy
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.
E-Cigarettes
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.
Electronics
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
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.
Printing
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.
Chapter Seven – What are the classifications of modular clean rooms?
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.
Maintaining Clean Room Classification
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.
Chapter Eight - What are the benefits of modular clean rooms?
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.
Modular Clean Rooms Benefits
Construction
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
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.
Maintenance
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.
Operating Green
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.
Performance
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.
Certification
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.
Tax Advantage
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.
Conclusion
A modular clean room is a prefab controlled environment that is constructed to limit the presence of sub-micron particulates.
Modular clean rooms provide flexible design and fast assembly, which allows them to be quickly installed and immediately ready for project processing.
Modular clean rooms can be installed in any type of manufacturing environment to provide controlled uncontaminated conditions for product and equipment testing.
Much like the standard, permanent clean room, modular clean rooms vary according to the industry that they serve.
The main organization for the classification for clean rooms is the International Organization of Standards (ISO), which was founded in 1947.
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