This article contains in depth information about softwall cleanrooms and their use.
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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. They are easy to assemble with lightweight sections and are significantly less expensive than hardwall permanent cleanrooms. Softwall cleanrooms are versatile and adjustable such that they can be expanded to meet changing needs or easily moved for convenient access.
The standard sizes of softwall cleanrooms range from 4 feet by 4 feet up to 24 feet by 36 feet. The flexibility of softwall cleanrooms makes it possible to design and create multiple configurations and sizes depending on customer needs. Aside from the standard sizes, softwall clean rooms can have additions and adjustments that instantly change their size to fit new and unique conditions.
Softwall cleanrooms have multiple uses due to their ability to be portable, small size, and having the capability to fit into confined or limited spaces. They can be disassembled when not needed but be reassembled to meet production needs. The practicality and adaptability of softwall cleanrooms make them ideal for small manufacturers who require controlled conditions or large manufacturers looking for a contaminant free portable environment.
There are multiple factors to consider when designing a cleanroom, which partially includes its International Organization of Standardization (ISO) classification. For example, an ISO 8 cleanroom can be entered without passing through an airlock, while an ISO 5 cleanroom requires the addition of an airlock or two. Additionally, the HVAC system has a great deal of influence on the capabilities of a softwall cleanroom.
The supporting frame of a softwall cleanroom is made of powder coated steel or aluminum uprights, cross sections, and ceiling frames. The frame can support the filtration system, air handling units, light fixtures, and ceiling tiles. The dimensions of the frame are determined by the needs of the customer. With steel tubular framing, the ceiling structure has welded T bars to support the filters.
The ceiling of a softwall cleanroom is a grid system that is supported by lightweight connectors that join the pieces of the grid. The two types of ceiling grids include self supporting and suspended. The design of self supporting ceiling grids requires the use of heavy duty aluminum or steel with the number of posts depending on the height and weight of the ceiling. Standard self supporting ceiling grids are not walkable, which can be adjusted if it is necessary for maintenance personnel to be on the ceiling grid.
Hanging ceiling grids use turnbuckles and steel rods to support the ceiling, lighting, and filters. Though they have the extra support, they are not walkable.
The height of the softwall cleanroom’s ceiling can be from seven to ten feet, with custom sizes being available. A two inch minimum clearance is necessary between the filtration units and the facility ceiling, with the height of the filer units being 16 inches.
Walls for softwall cleanrooms are made of clear, flame retardant, outgassing thick vinyl strips. The vinyl panels are lightweight, easy to install, and easy to clean. The walls of softwall cleanrooms can be made in various colors to match the needs of a process and the frequency of exposure to UV sensitivity. They are made of 40 mil vinyl with door panels made of 80 mil. The panels are hung overlapping to create a barrier against the external environment.
The 40 mil vinyl panels have double the required material, making them tear resistant. They are attached to the support frame with a grip track mounting system to prevent contamination.
The air treatment system is the heart of a softwall cleanroom and is dependent on the airflow pattern, air supply, HEPA filters, and the room's air pressure. The classification of the air treatment system is determined by the air change per hour (ACH), which is used to set the ISO classification. The variations in the air change rate run from 10 times per hour up to 250 times per hour. The higher the air change rate is, the higher the ISO classification.
High efficiency particulate air (HEPA) filters are the industry standard for cleanroom air treatment. Filtered air from a HEPA filter has 99.97% of particulate matter at 0.3 microns removed including dust, pollen, animal dander, bacteria, and various forms of contaminates. They are made of randomly placed fiberglass fibers of varying densities. The diameter and thickness of the fibers is the reason for HEPA filter efficiency.
The density of HEPA filters requires a powerful air circulation system to be able to move air through them.
The HVAC system is designed to control the temperature and humidity in a softwall cleanroom in half ton to two ton capacities. For softwall cleanrooms, HVAC systems need to have a multiple panel design for variable ducting to meet the changing needs of softwall cleanrooms. Condensers can be air or water cooled depending on the needs of the softwall cleanroom.
Air is pulled into the HVAC system from outside the cleanroom and drawn through prefilters. Next, it goes through the HVAC system and out through the HEPA filters into the room. As the air is pushed into the cleanroom, it is forced vertically downward toward the floor where it exits underneath the vinyl plastic strip walls. In special circumstances, air conditioning may need to be ducted from the HVAC system of the building or some other form.
The HVAC air flow system of a softwall cleanroom is a single pass, which is unlike solid wall cleanrooms that may have single pass or recirculating systems.
The amount of lighting is dependent on the types of processes that will be conducted in the cleanroom. This aspect of a softwall cleanroom installation is determined well in advance to ensure the correct illumination to fit the conditions. The major difficulty with softwall cleanroom design is the placement of the lighting since the major thrust of the design is to ensure proper air movement and filtration.
Some common forms of softwall cleanroom lighting are recessed, surface mount, and teardrop. Of the three, teardrop has issues since it affects the headroom of a softwall cleanroom.
Recessed troffers are designed to fit in the suspended drop ceiling. They fit tightly in place to provide excellent illumination without interfering with the airflow. Recessed troffers fit flat along the ceiling line, leaving plenty of space for the plenum. They are found in the highest classifications of softwall cleanrooms.
Surface mounted softwall cleanroom lighting is only used in lower classifications of cleanrooms due to their interference with the airflow. They are mounted on the ceiling and are not recessed, which is why they interfere with the airflow.
Teardrop lighting hangs below the ceiling to make room for airflow. Their shape is designed to avoid interference with the airflow and not create turbulence. Though teardrop lights do not interfere with airflow patterns, they take up headroom.
Softwall cleanrooms have been increasing in popularity for several years due to their lower cost and flexibility. They are tent like, lightweight, and easy to assemble. Part of their flexibility is their ability to be freestanding or have ceilings suspended from the structure of a building. They are much smaller than hard wall clean rooms and can be adjusted to fit into any space.
There are very few distinctions between softwall cleanrooms since the majority of them have the same features, such as vinyl walls and tubular aluminum or steel frames. Aside from the basic configuration of softwall cleanrooms, there are certain features that can be added to them that can differentiate them.
The ultimate flexibility of a softwall cleanroom is one that is exceptionally portable and placed on casters. This configuration makes it possible to move the cleanroom to any location where it is required. In the case of all types of cleanrooms, especially steel framed ones, casters need to be sturdy, capable of supporting the weight of the frame, self locking, and have sealed bearings.
Ceiling suspended softwall cleanrooms are a very flexible version of softwall cleanrooms that make it possible to easily adjust the dimensions of the cleanroom when needed. They have a significantly lower cost when the potential for constant dimension changes may be necessary.
The ceiling grid for the softwall cleanroom is hung from the joists of a building’s ceiling. The softwalls or curtains are hung from the edges of the softwall cleanroom’s ceiling using hook beads on the tops of the curtains, which makes it possible to slide them in the tracks of their frame. The softwalls of the cleanroom do not have a frame but hang like curtains.
There are two types of frames for softwall cleanrooms: steel and aluminum. Both metals are shaped in tubular form with aluminum tubing being extruded and having a higher per square foot cost. The framing material supports the cleanroom’s softwalls and its ceiling. It defines the shape of the softwall cleanroom and its size.
Aluminum framing is an extruded aluminum alloy with a white powder baked on the coating. It is leveled with padding and fasteners placed at the ends of the tubing to meet the needs of the environmental conditions. The major benefit of aluminum framing is its lightweight, making it easier to disassemble and move. The aluminum tubing makes it possible to easily expand softwall cleanrooms or repurpose them.
Steel framing is made of tubular steel that is formed, welded, and powder coated. To enhance the strength of the steel framing, the tubing is tightly bolted and secured. The bolting allows for adjustments to the size of the cleanroom to accommodate changes to processes or testing needs. Steel framing is heavier and more difficult to move but costs less than aluminum framing.
One of the features of softwall cleanrooms that users enjoy the most is the ability to expand and contract the workspace to fit the needs of technicians. This particular aspect of softwall cleanrooms makes it possible to add to the initial softwall cleanroom to drastically increase its size to potentially match the size of a hardwall built in cleanroom.
In the example below, an 8x8x8 cleanroom is doubled in size by the addition of an 8x12x8 expansion.
Free standing horizontal airflow softwall cleanrooms have horizontal airflow provided by laminar flow built into the sides of the clean room. Air is pulled through the back of the unit and pushed through the HEPA filters. The horizontal design places the workspace closer to the filtered airflow. It offers improved environmental conditions for certain applications.
Horizontal free standing airflow softwall cleanrooms are used by life sciences, medical instrument manufacturers, pharmaceutical companies, and electronics manufacturers.
Gowning rooms are typically found in hardwall or modular cleanrooms. With softwall cleanrooms, they can be an additional feature for higher classification softwall cleanrooms. Gowning room curtains are attached to the ceiling grid system to provide a separate enclosed space for technicians to prepare for entering the uncontaminated cleanroom.
There are a variety of choices for the walls of a softwall cleanroom with Polypropylene, vinyl, and Polyvinyl Chloride (PVC) being the most common ones. The purpose of the types of soft plastic walls is to insulate the cleanroom environment from the intrusion of contaminants. They can be easily attached and detached as required to fit the testing conditions.
Vinyl, which can be made in different colors to meet the needs of a process, is lightweight and easy to install and clean. The different types of vinyl strips are 40 mil with door panels being heavier and sturdier. The vinyl panels are overlapped when they are hung for extra protection of the cleanroom environment. The thick vinyl strips of the walls are exceptionally thick to prevent tearing and are attached to the frame with a grip track mounting.
PVC is one of the most recommended materials for cleanrooms and areas that are sensitive to contaminants. The properties and characteristics of PVC make it easy to clean and capable of being kept contaminate free.
PP is used when purity, strength, and rigidity are required. It is resistant to chemical leaching and corrosion as well as being resilient against impact and damage from freezing. The versatility of PP makes it possible to fuse it to other materials without needing to be glued. Its exceptional resistance to heat makes it ideal for conditions where autoclaves or heat tests are performed.
High density polyethylene is impact and abrasion resistant with a low friction coefficient and is FDA approved. It is an ideal fabric for softwall cleanrooms due to its high durability and resilience. When woven as a fabric, polyethylene has exceptional tensile strength and tear resistance with a Class 1 flammable rating.
As with the other materials for use as softwalls, VCP has a very high tear and abrasion resistance, making it ideal for a wide variety of applications. It is 100% polyester with a smooth, even polyvinyl chloride coating. The application of the coating gives the polyester a fire retardant, anti-fungal, and UV stabilizer. The resilience and strength of VCP make an ideal material for the rigors of the work performed in a softwall cleanroom.
Vinyl, PVC, and PP make it possible to choose the exact material to fit the conditions, applications, and work performed in a softwall cleanroom.
As with hard rigid walled cleanrooms, softwall cleanrooms have a selection of different types of entrances with overlap, plastic strip curtains, sliding, automatic rolling doors, and hinged swing doors being the most common. The style of the entrances significantly affects the classification of a softwall cleanroom since it determines the number of contaminants that enter the room. It is for this reason that high classifications have pass throughs or gowning rooms to limit the number of contaminants.
Vertical airflow softwall cleanrooms are the most common types with a laminar flow system located in the ceiling of the softwall cleanroom. The HVAC system pulls air from the surrounding environment and forces it through the HEPA filters down into the workspace where it exits underneath the softwalls just above the floor.
The most important criteria softwall cleanrooms have to meet are the requirements for their ISO classification. The design of softwall cleanrooms does not make it possible for them to meet the highest ISO standards since they are not capable of the type of tight seal found in rigid and hardwall cleanrooms.
Regardless of their disadvantages, softwall cleanrooms can meet some of the stringent stipulations of the ISO and are classified as ISO 5 up to ISO 8. This meets the needs of a wide range of industrial applications.
Cleanrooms are classified according to the cleanliness levels of the air inside the room. The classifications are based on the quantity and size of the particulate matter in one cubic meter of air. There are two systems used to classify cleanrooms, which are the United States Federal Standard 209E (FS 209E) and the International Organization of Standardization (ISO). Both forms of classification are widely used by manufacturers to designate the cleanliness of their cleanrooms.
The classification systems run from ISO 1 to ISO 9 for the ISO system, while the FS 209E system runs from Class 100,000 to Class 1. There are further standards that are industry specific as well as international standards such as EU GMP and USP.
The nature of softwall cleanrooms makes it impossible for them to reach classifications below ISO 5 or FS 209E Class 100. For the majority of industries, these classifications are sufficient for their purposes. The more restrictive classifications are required by exceptionally sensitive and highly technical industries.
To reach ISO 5 cleanliness standards requires the use of an ISO 8 anteroom followed by an ISO 7, ISO 6 before entering an ISO 5 cleanroom. Though this is the theoretical model, it may not be practical for an ISO 5 softwall cleanroom. To overcome the rigorous requirements, two or three additional softwall cleanrooms can be added to the ISO 5 cleanroom.
There are specific standards regarding the airflow for an ISO 5 softwall cleanroom, which is a major factor in accomplishing its classification. The standard is that the airflow must be unidirectional from a set of HEPA filters located in the ceiling grid. This type of airflow requires the consumption of much more air. If the size of the room is less than eight meters, then horizontal airflow is permitted. The number of filters and air handling units make the airflow required much more expensive.
The air exchange rate for an ISO 5 softwall cleanroom is 240 to 360 changes per hour.
For a softwall cleanroom to be able to reach a classification of ISO 6, it requires one or two airlocks prior to entry. The number of airlocks depends on the room’s size, the types of processes being completed, and the number of people in the room. Though unidirectional airflow is recommended, it is not necessary if the room is less than four to six meters wide. The air exchange rate for an ISO 6 softwall cleanroom is between 90 to 180 changes per hour.
The ISO 7 is the most common class of cleanroom. They are widely used in an assortment of industries including clinical manufacturing, electronic components, and the nutraceutical industry. An ISO 7 softwall cleanroom has an air exchange rate of 30 to 60 per hour with 352,000 particles per cubic meter at sizes of 0.5 μm.
An ISO 8 softwall cleanroom does not require the entering of an airlock or previous chamber before entering the workspace. Some ISO 8 softwall cleanrooms may have a gowning room depending on the applications and type of work being completed. ISO 8 cleanrooms have an air exchange rate of 15 to 25 air changes per hour. The less restrictive nature of ISO 8 cleanrooms makes them flexible enough to be used for certain pharmaceutical manufacturing, medical device manufacturing, and the automotive industry.
The chart below shows the ISO standards for softwall cleanrooms as well as their FS 209E equivalents.
Softwall cleanrooms have become the norm for many industries due to their low cost and the elimination of the need to restructure the existing space. From pharmaceuticals to aerospace, softwall cleanrooms are an essential part of assembling, testing, examining, and certifying crucial components and systems.
Cleanrooms are a major part of the production and perfecting of pharmaceuticals for general use. Pharmaceutical companies have hardwall or modular cleanrooms for the testing and mixing of ingredients. Under certain conditions, it is necessary to have a special environment to act as mixing labs that do not necessarily require a classification lower than ISO 7. The wall consistencies of softwall cleanrooms are ideal to fit the requirements with their easy to install filtration systems and mobility.
The demands of the plastic industry can change rapidly, whether it is producing poly bags or manufacturing medical devices. The flexibility of softwall cleanrooms makes it possible to quickly shift the focus of production to meet the increased demand. Softwall curtains make it possible to expand the workspace of a softwall cleanroom and reconfigure it to meet the needs of a project.
The small footprint of softwall cleanrooms makes it possible to fit them into a limited workspace and be streamlined to fit the needs of the work to be completed.
With the legalization of cannabis use, the federal government has established standards for the production and synthesizing of cannabis in controlled conditions. A central aspect of the process is the use of softwall cleanrooms that provide an environment for the manufacture of medical grade cannabis. The FDA has stipulated that softwall cleanrooms for the manufacture of cannabis must meet an ISO 5 or ISO 7 classification. These classifications ensure that manufacturing processes meet the necessary quality and safety certification requirements including the safety of workers.
E-liquid and e-cigarette manufacturing needs federal regulations regarding their production processes. The American E-Liquid Manufacturing Association has established a set of standards regarding the manufacturing of e-liquids that specifies the use of food preparation requirements. The FDA stipulates that e-cigarettes be manufactured using cleanrooms.
Since the demand for e-liquids is rapidly changing, softwall cleanrooms are an ideal environment for processing the raw materials for the safety of workers and the quality of the product. The fact that e-liquid production only necessitates an ISO 7 or ISO 8 environment makes softwall cleanrooms the right choice.
The semiconductor industry requires flexible space for the assembly and testing of its products. In many instances, the necessary workspace can spread across the assembly floor to provide the needed workstations and part storage. The many processes require cleanrooms with an ISO 5 to ISO 7 classification to meet the particulate count needed to create the exceptionally clean working environment.
As part of the special conditions for semiconductor construction, special dark curtain areas are necessary for UV inspections. The flexibility of softwall cleanrooms makes it possible to turn any space into a UV examining area with the addition of dark curtains.
The traditional image of a cleanroom is a secluded part of a technical, medical, or pharmaceutical company that is restricted to qualified and trained personnel. In most cases, this conceptualization involves a sealed hardwall room with a single entrance that is hygienically clean. Though this is a traditional view, such cleanrooms are very expensive and require detailed planning for their construction.
Many industrial operations would enjoy the convenience of such well-constructed facilities, but their cost is prohibitive and may not be necessary for a company’s operations. In the majority of cases, a controlled workspace with specific standards is sufficient to meet the demands of production.
Softwall cleanrooms are widely used and contaminant free environments that have to be carefully chosen. During the selection process, it is essential to check industry standards and recommended practices for an application, practice, or process to ensure the proper use and implementation of a softwall cleanroom.
Softwall cleanrooms have rapidly become an essential part of industrial operations that require a clean workspace but not one that has exceptionally high particulate requirements.
Softwall cleanrooms require fewer materials and tools to construct. In a short time, a small crew of workers can have a softwall cleanroom up and operable, which further lowers its cost. Though softwall cleanrooms can be produced quickly and assembled just as fast, they still have the capabilities to provide a controlled environment without compromising quality or integrity.
As a company’s budget requirements change, softwall cleanrooms can be maintained and configured to meet the shift in costs and demands. Since softwall cleanrooms have the architectural design and engineering completed in advance of installation, their costs are substantially less.
Though softwall cleanrooms have softwalls and tube supports, they still have the same durability that is required of heavy equipment that is part of production. The alloyed aluminum or steel supports are rugged and capable of withstanding the demands of a highly efficient production operation. The clear plastic walls are made of materials that resist contaminants and are easily cleaned. The strength of the materials are not damaged by temperature or humidity and meet the stringent standards required of all cleanrooms.
This aspect of softwall cleanrooms is one of the reasons that they are enjoying such popularity. A softwall cleanroom can be configured to fit into any space regardless of the size of the space. Softwall cleanrooms can be as small as 4x4x8 with all of the necessary components to meet ISO requirements.
Additionally, as the demands of a company’s applications and production changes, softwall cleanrooms can be expanded or contracted to meet the changing conditions.
When space is limited, it is necessary to have a compact and flexible cleanroom that can adapt and fit the conditions. A softwall cleanroom is a fit anywhere and go anywhere type of equipment that can easily accommodate any environment. As a company grows, its softwall cleanrooms will grow with it.
When a hardwall cleanroom is being planned, it requires a team of experts, technicians, designers, and construction workers to install all of the elements to meet the room’s ISO classification. In the case of softwall cleanrooms, a company can provide a cleanroom manufacturer with the necessary dimensions and configuration and have a softwall cleanroom installed in a few hours. All of the planning and preparation has been completed by the manufacturer. They simply take the existing conditions and adapt the softwall cleanroom to fit them.
Although there may be variations between softwall cleanrooms, every softwall cleanroom is guaranteed to perform up to its established standards regardless of the circumstances. The factor of dependability is one of the major selling points for softwall cleanrooms. Every manufacturer stands behind the quality of their products and the ISO classifications of their softwall cleanrooms designs.
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