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, controlled environment that is constructed to limit the presence of sub-micron particulates. These specially designed rooms are assembled using prefabricated panels inserted into a frame. They are purchased as a kit to be assembled or can be constructed by a technician. Modular clean rooms are less expensive than traditional clean rooms because of their basic design and the low cost of the various components.
Modular clean rooms provide flexible design and fast assembly, which allows them to be quickly installed and immediately ready for project processing.
The forms of modular clean rooms are determined by the types of walls used to construct them, which are hard or soft. Hard wall versions have solid panels made from plastic, aluminum, gypsum, or wood. Soft wall modular clean rooms have various types of curtains, such as plastic or vinyl.
Chapter Two – Uses for Modular Clean Rooms
Modular clean rooms can be installed in any type of manufacturing environment to provide controlled uncontaminated conditions for product and equipment testing. They are standalone units that provide exceptionally clean conditions for a variety of processes and functions.
The design and engineering of modular clean rooms create conditions for isolating a piece of equipment or a process from contamination by dirt, dust, air, and ambient temperatures. They are extensively used by pharmaceutical, biotechnological, medical device, and microelectronic industries.
Uses for Modular Clean Rooms
Since modular clean rooms are mobile, they can be constructed in areas that are suffering an epidemic to complete on site testing. This is especially crucial in isolated areas that do not have access to proper medical facilities.
In cases where companies are growing and expanding rapidly, modular clean rooms are an easy and convenient method for increasing testing facilities. They are ideal for such purposes since they can be easily assembled and be available for use within less than a day. A modular clean room brings extra workspace at low cost.
Modular clean rooms are ideal for situations where there is hazardous waste but no means to control it. In those conditions, a modular clean room can be rapidly assembled to deal with the waste material and contain it.
University professors that require a research chamber to offer demonstrations to students, but lack the space, can make use of a modular clean room for its low cost and flexibility. Having an enclosed controlled environment provides the opportunity to give students real world experience without the dangers.
Modular clean rooms for educational purposes meet the strict financial requirements that are a constant problem for professional educators. It is far easier to convince the governing board to purchase a clean room than build a new building.
Situations may arise in manufacturing where a part or component requires a deeper cleaning, beyond the traditional cleaning that is part of production. These conditions may happen for a company that does not normally use clean rooms, which is perfect circumstances for the use of a modular clean room.
The need for a deeper cleaning of parts may be for the same reason as the use of clean rooms for hazardous materials. For some manufacturers, this is not a regular occurrence but requires immediate action.
Pollutant Free Environment
The purpose and design of modular clean rooms is to create an environment where pollutants and contaminants have been removed, and the air is bacteria free. These conditions are created when it is necessary to remove dangerous air particulates that may be contaminating the outside air.
Modular clean rooms have the ability to be immediately setup and ready to operate limiting the amount contaminants that will be released.
Whenever it is necessary to handle volatile substances, manufacturers require the use of a clean space that can be controlled and closely monitored. Though it is possible to use a permanent clean room for such purposes, modular clean rooms are a less expensive and economical way to create the required conditions.
There are certain aspects of assembly operations that require an uncontaminated environment. These types of conditions do not require the strictest types of protocols but benefit from the use of environmentally controlled conditions. Modular clean rooms can be assembled around a production line and offer secure conditions.
CNC clean rooms provide a protected area for CNC machines away from harmful debris and contamination. The use of CNC protection avoids production rejection and lowers overall cost. Modular clean rooms can be installed to cover existing equipment or be a part of new construction.
A CNC clean room enclosure provides a thermal barrier for temperature control, suppresses exterior sounds, and comes in several designs and configurations.
Chapter Three – Types of Modular Clean Rooms
Beyond the different types of walls for modular clean rooms are the different types of modular clean rooms. Much like the standard, permanent clean room, modular clean rooms vary according to the industry they serve. The robust design and ease of installation of clean rooms has made them a dynamic part of several growing industries.
The classification of a clean room is based on the quality of air in it, which is determined by the number of aerosol particles, airborne microbes, dust, and chemical vapors. The air of every modular clean room is tested and graded to determine its classification.
The design and type of a modular clean room is greatly dependent on production, manufacturing, and assembly requirements, which determine the standards of cleanliness required. The components, materials, surfaces, and types of interior are established long before the assembly. The agreed design features are strictly followed at the time of construction.
Types of Modular Clean Rooms
Coordinated Measuring Machines (CMM Clean Rooms)
CMM clean rooms are designed as a protected environment for measuring devices such that X, Y, and Z axis machines provide precise and accurate readings. They have sound and temperature controls as well as protection against fire and possible damage to the measuring equipment. The purpose of CMM clean rooms is to test manufacturing and assembly processes against design intent with precise recordings of X, Y, and Z coordinate target data.
Nanotechnology Clean Rooms
The use of nanotechnology clean rooms involves industries that produce semiconductors, medical instruments, and pharmaceuticals. The products from those industries require a highly sensitive environment that is free of particles, gases, and contaminants that could stick to components and affect product quality.
High Bay Modular Clean Rooms
High bay modular clean rooms are specially designed to be used by the aerospace industry. They are constructed under the same stringent standards of other clean rooms but have a very high ceiling and custom designed walls that are constructed in accordance with industry requirements.
Grow and Cultivation Clean Rooms
Grow and cultivation clean rooms are designed for hybrid pollination as well as specially created temperature and humidity conditions for incubation. This type of clean room requires insulated walls that provide a thermal barrier against the encroachment of outside elements.
A necessary feature of grow and cultivate chambers is protection against outgassing and microorganisms that can impede production and damage unique plants. Since the movement of crops may be necessary, large entryways may be necessary.
Coating Clean Rooms
The purpose of coating clean rooms is to prevent any other types of materials contaminating the coating. To avoid the intrusion of unwanted substances, the coating process is completed in a controlled environment that is isolated from other production operations.
An additional factor that necessitates the use of a clean room for the coating process is the potential for combustion since certain coating materials have inflammatory chemicals. The restricted enclosure of a clean room provides safety for the operation and 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
Products can be damaged during production by airborne particles, humidity, and variations in temperature, which can diminish their quality. To ensure products meet quality standards, manufacturers have them produced in a controlled, protected, and exceptionally clean environment, which is provided by a modular clean room.
Machine clean rooms isolate equipment from the wide range of factors that can cause them to be rejected at final inspection. The use of a modular clean room, as part of the production process, can significantly reduce waste and increase profits. Additionally, cross contamination from other equipment is eliminated.
Aseptic Clean Rooms
Aseptic modular clean rooms are free from any form of contaminants and are built for life science, biomedical, and medical device industries. Their interior is completely seamless, durable, and non-shedding to be able to withstand the constant cleaning and sterilization. The design of aseptic clean rooms is to prevent the buildup of contaminants and bacteria.
Chapter Four – How Modular Clean Rooms are Made
The process of constructing a modular clean room begins with the selection of the components, which includes the materials for the frame, walls, ceiling, floor, and air filtration system. The basis for the selection process depends on the desired classification. In order for a clean room to have a higher classification, it has to be manufactured using high quality materials and components.
Modular Clean Room Materials
The first consideration when choosing the type of clean room depends on the types of walls, which can be solid or fabric. Each type, fabric or solid, comes in many varieties that can be custom fit to meet the needs of the manufacturing process or testing needs.
Types of Panels
PVC is highly durable and provides an excellent form of barrier against the outside environment. It is resistant to the effects of chemicals, solvents, and fluids. PVC Softwall panels can be used as a total enclosure or as a covering for the entrance.
Polyethylene Terephthalate Glycol (PETg)
PETg is a thermoplastic that is significantly resistant to chemicals and has excellent durability. The main feature of PETg, that makes it different from other forms of plastics, is its transparency, which allows for close observance of procedures from outside the enclosure.
The main use of PETg in the construction and assembly of modular clean rooms is as observation windows and wall panels.
Other types of Panels
Common categories of modular clean room panels:
- Softwall - plastic, plastic laminate, or vinyl
- Hardwall - fiber-reinforced plastic (FRP), high-density polyethylene (HDPE), aluminum, steel, or vinyl
- Rigidwall - rigid wall panels are similar to hard wall panels but are less expensive and made of clear flat material.
Types of Frames
When steel is used in the construction of a modular clean room, the corners and ceiling are welded. For added cleanliness, the steel has a powder coated finish. The wall panels for a steel frame clean room can be of any type of materials.
The frames for aluminum modular clean rooms are extruded using anodized aluminum. The benefit of an aluminum frame is its flexibility, which makes it easy to place it in difficult to fit locations. The light weight of aluminum and ability to be shaped and formed into any dimensions makes it customizable and easy to install.
Modular Clean Room Construction
Clean Room Walls
The construction of a modular clean room begins with the selection of the wall materials, which is the most important component. The types of walls affect the cleanliness of the room and how easy it will be to clean. There are a wide variety of materials that can be used.
For modular clean rooms, the walls can be moved, shifted, and repositioned to meet the needs of a particular testing, which is one of the reasons for using a modular clean room. A critical factor for clean room wall selection is how easy they can be cleaned and how sanitary they must be to meet certain classifications, such as aseptic requiring exceptional cleaning.
Clean Room Floor
As with the walls, the floor of a modular clean room will have an effect on the room’s classification. It must be able to withstand multiple cleanings from a variety of solvents and cleaners.
The common types of modular clean room flooring are:
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.
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 is flexible and adjustable for the installation of venting, lights, and filters without the need to change the orientation of panels. Since the bottom surface is flush and free of protrusions, the covering for the ceiling can be run at any location without a concern for interfering with the grid.
A key feature of ceiling panels is that they fit tight and snug with the edge of each panel securely engaged to its adjoining panel with a fixed metal spline. Nonprogressive ceiling panels allow for disengagement of the panel for adjustments and removal.
Ceilings are made from large sheets that are treated and cut into tiles. To ensure a tight and secure fit, gaskets or some form of seal may be used. During installation, the tiles are tightly fitted to avoid ambient air from entering the clean room.
Much like the other factors related to a modular clean room, the choice of lighting can have a significant effect on the working conditions and the operation of the room. The variety of types of lighting include incandescent, fluorescent, and LED. Unlike permanent clean rooms, a great deal of thought has to be put into how to incorporate the lighting in a modular clean room.
The influence on the lighting is the coordination with the air supply system to minimize contamination. Since the air supply system is located in the ceiling, the lighting has to be installed around it.
A concern for the lighting system is its cost since it will influence the energy bill as well as have an initial cost at installation. The next consideration is maintenance cost, which is related to keeping the light fixtures clean of contaminants. Since the operations of a clean room involve precision instruments, the foot candle levels need to be very high.
Types of lighting:
- 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 most critical part of a modular clean room is the air filtration system, which circulates pure, filtered air with extremely reduced contaminant particulates. To achieve such extraordinary conditions, clean rooms use high efficiency particulate air (HEPA) filters that remove 99.95% of particulates.
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.
Filtered air enters the room from the overhead fans and passes out through the floor or vents in the floor. Single pass modular clean rooms pull air in through the ceiling and exhaust it out. For recirculating modular clean rooms, the air that exits is pulled back through the filtration system and reenters the room. A negative design of an air flow system keeps the contents of the clean room away from the area outside the clean room.
Laminar air flow systems use laminar hoods that keep air flowing in a single and straight direction. They direct air downward into the room and are made of metals that do not shed or release contaminating particles. Laminar air flow systems are connected to and part of the filtration system.
There are several features that can be added to a modular clean room that increase the control of 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 – Industries That Use Modular Clean Rooms
The unique nature of clean rooms and their capabilities have made them a necessary part of several industries since they provide conditions that cannot be replicated in a production environment. Recently, with the rise for the need for intricate and precise electrical components, modular clean rooms have become an essential part of several industrial processes.
Modern manufacturing has become more concerned about the quality and lifespan of their products . In order to determine the quality of a product, it is necessary to test it in an environment uninfluenced by contaminants to get a true reading of the products strengths and weaknesses. It is for this reason that clean rooms have become so important in providing accurate and precise data.
Industries That Use Modular Clean Rooms
The critical nature of equipment produced for aerospace requires that components be produced free of the dangers of contaminants and particulates. This can only be accomplished in a clean room. The slightest flaw or weakness in a sensitive instrument can result in dangerous conditions and substantial losses.
Small specs of paint, deformities, or contaminated materials can cause equipment and components to fail. To meet these challenges, modular clean rooms for aerospace are individually designed and assembled to precisely fit manufacturer requirements.
The automotive industry makes extensive use of modular clean rooms from the beginning process to the final product. In the initial design phase, prototypes are tested and examined in clean rooms to establish their viability.
The use of clean rooms is used at every step of the supply chain due to the technological innovations and advancements made in automobile design. The major reason for an increased use of clean rooms is because of the ever growing complexity of automobile components. Much like aerospace, the slightest flaw or contaminant can cause component failure.
The demanding regulations and health standards for the production of drugs and medications has made the pharmacological industry a primary user of clean rooms. The industry has a constant concern for any form of bacterial contamination and takes drastic measures to ensure every product is sterile and clean of any possible side effects from production errors.
Every aspect of the production process is controlled in environments that are specially designed for each step of production. The pharmaceutical industry is driven by governmental regulations that require inspections of processes and conformity to standards.
Medical instruments that come in contact with the body have to meet high standards of sterility and cleanliness. Many of the devices produced by manufacturers will be used as implants or surgical instruments. The type of clean room for medical devices is a constrained and controlled environment that has extremely low impurity levels for dust, airborne microbes, aerosol particles, and chemical vapors.
A medical modular clean room is a laboratory used as a part of medical instrument production or research. Modular clean rooms play an important role in ensuring patient and product safety. Medical device manufacturers depend on clean room technology to eliminate airborne particulates and maintain an antimicrobial environment.
Unlike many other clean room processes that can cause flaws in products, errors in medical clean rooms can lead to severe and life threatening illnesses. It is for this reason that medical instrument and equipment manufacturers rely on the safety of clean rooms for their protection and the protection of the public.
Though dairy products have the same potential of being contaminated as other products, the requirements for dairy clean rooms are not as stringent as those for pharmaceutical, medical, and electronics. The regulations for dairy manufacturing vary depending on the type of product being produced.
The rules for clean room use for milk are less stringent than those for yogurt where bacterial activity is a part of the production process. Clean rooms for dairy have the same concerns as medical and pharmaceutical producers, which is contamination by bacteria, yeast, and mold. The design of dairy clean rooms concentrates on keeping the air in the production area clean and contaminant free.
The production of e-cigarettes necessitates clean rooms that meet the same standards that are applied to medical and pharmaceutical products. The basic concern is chemical vapors that can contaminate the products and make them dangerous. To meet this challenge, clean rooms for e-cigarettes meet the most severe of the International Organization of Standardization (ISO) requirements. Even the slightest amount of contamination can be harmful.
E-cigarette manufacturers are required to meet the Class 7 and higher requirements for their clean rooms. This means that the allowed particulates cannot exceed 0.5 microns.
Modular clean rooms for the electronics industry are less expensive and more flexible than traditional clean rooms. The design of modular clean rooms allows for expansion and modification of the clean room depending on the needs of production.
All of the adjustments and changes allows producers to change the goals of the clean room at minimal expense. Since modular clean rooms can be changed, stored, and relocated, they become a reusable asset that can fit into any requirements. Components can be disassembled and used in a variety of locations.
For the electronics industry, modular clean rooms ensure the stability and performance of their products by producing them in contaminant free environments. The manufacturing space must be extremely clean and clear.
Precision engineering designs machines, fixtures, and structures of extremely high tolerances that must remain stable over time. The sensitive and technical nature of the parts produced requires a controlled and secure environment to protect the demands of precision engineered products.
Modular clean rooms for precision engineering are ultra clean and self contained for maximum protection from damaging pollutants and pathogens. By maintaining such conditions, manufacturing, testing, and production of extremely small components proceeds flawlessly. The constant concern is the slightest minute contagion can radically alter the success of a product.
Though some printing processes involve the use of large machines that use ink as a part of the printing medium, there are artistic and fragile printing processes that require great precision and controlled conditions. Those forms of printing are screen and digital or computer assisted printing.
In the printing of delicate and precise products, the slightest form of dust, spec, or breeze can destroy and ruin a workpiece. To avoid such intrusions, screen and digital printers use cleanrooms where they can control the conditions and ensure the uniformity of the environment.
Chapter Six – Modular Clean Room Classifications
The main organization for the classification for clean rooms is the International Organization of Standards (ISO), which was founded in 1947. The purpose of the organization is to publish international standards covering scientific research and various industrial practices.
Though membership in the ISO is voluntary, the standards established by the organization are the foundational guidelines used by every industry that uses clean rooms. Since its beginnings, the ISO has published 20,000 standards and guidelines for chemicals, the handling of volatile materials, and sensitive instrument testing.
Clean room classifications are determined by the level of cleanliness that is measured by the size and quantity of particulates in a cubic volume of air. ISO classifications start with ISO 1 as being the strictest with ISO 9 being the lowest and least clean classification. The majority of clean rooms are between 7 and 8.
Though the ISO is the most recognized clean room classification system, the United States has the Federal Standards 209 (FS209E) clean room classification system that was replaced by the ISO but is still used by many producers. FS209E has six classes with Class 1 being the cleanest and 100,000 being the dirtiest. In the ISO system, a FS209E classification 1 is equal to an ISO classification 3 with ISO classification 8 being equal to a FS209E classification 100,000.
The two systems can be seen in the charts below.
Though the ISO and FS209E are recognized as significant classification systems, the United Kingdom has their set of standards as well as the European Union. Regardless of the many types of standards and classifications, most countries and manufacturers use the ISO system as the guideline for classification.
Maintaining Clean Room Classification
Though a cleanroom may have been classified as being in accordance with the specified standards, it can easily lose its classification by having a poor air filtration system, which depends a great deal on the number of filters required and the efficiency of the air flow system. Modular clean rooms are regularly checked to ascertain their compliance and classification.
The guiding factor in maintaining a classification rating is the filtration system, which is the most significant part of a clean room. The types and number of filters greatly influence the particulate count and modular clean room efficiency. Every modular clean room has a maintenance schedule as well as established practices regarding checking and changing HEPA or ULPA filters.
The biggest problem with clean rooms has little to do with the mechanism or filters. Much of the difficulty involves the people who work in a clean room and their practices. Regardless of the amount of coverings and methods, most of the contamination of a clean room comes from workers and employees. This aspect of the process is closely monitored and examined by manufacturers to avoid losing the integrity of their clean room.
- 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.