This article contains in depth information about softwall cleanrooms and their use.
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A softwall, cleantent, or portable cleanroom is a modular structure with a prefabricated frame usually made from stainless steel or aluminum. Its design allows for rapid and straightforward assembly, depending on the size of the cleanroom. The walls are constructed from clear, flexible vinyl sheets, which may be tinted, opaque, UV filtering, ESD “Static Dissipative,” or low outgassing. The ceiling grid system, typically supported by the frame, incorporates ceiling tiles, light fixtures, and fan-powered HEPA filters similar to those used in stick-built and modular hardwall cleanrooms.
Softwall cleanrooms typically come in sizes ranging from 4 feet by 4 feet to 24 feet by 36 feet. Their flexibility allows for custom configurations and sizes tailored to specific customer requirements. In addition to standard sizes, these cleanrooms can be modified or expanded to accommodate new and unique conditions.
Softwall cleanrooms are more cost-effective compared to stick-built and prefabricated modular buildings and can be delivered and installed much faster. Typically, they require permits only for their electrical and HVAC systems. Assembly can be carried out by as few as two or three individuals. Since these cleanrooms are prefabricated, their assembly causes minimal noise and dust disruption. Depending on the frame design, resizing or reconfiguring a softwall cleanroom can be easily achieved by ordering additional components.
Softwall cleanrooms are highly versatile due to their portability, compact size, and ability to fit into tight or limited spaces. They can be disassembled when not in use and reassembled to meet changing production needs. Their practicality and flexibility make them suitable for both small manufacturers requiring controlled environments and larger manufacturers seeking a contaminant-free portable space.
Most softwall cleanrooms feature hanging, overlapping flexible vinyl panels that extend three to six inches above the floor to allow air from the filters to circulate. However, some modular designs use vinyl materials that are securely attached to the steel frame on all sides. These designs are modular but are not intended to be portable or movable.
When designing a cleanroom, several factors must be considered, including its International Organization for Standardization (ISO) classification. For instance, an ISO 8 cleanroom can be accessed without passing through an airlock, whereas an ISO 5 cleanroom necessitates one or two airlocks. Additionally, the HVAC system significantly impacts the functionality 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 consists of a grid system held together by lightweight connectors. There are two main types of ceiling grids: self-supporting and suspended. Self-supporting ceiling grids are made from heavy-duty aluminum or steel, with the number of posts varying based on the ceiling’s height and weight. These grids are typically not walkable, though adjustments can be made if access is needed for maintenance.
Suspended ceiling grids are supported by turnbuckles and steel rods, providing support for the ceiling, lighting, and filters. Despite their added support, these grids are not designed to be walkable.
The ceiling height of a softwall cleanroom ranges from seven to ten feet, with custom sizes available. A minimum clearance of two inches is required between the filtration units and the facility ceiling, and the height of the filter units is 16 inches.
Softwall cleanroom walls are constructed from clear, flame-resistant, and low-outgassing vinyl strips. These vinyl panels are lightweight, simple to install, and easy to clean. Available in various colors, the panels can be chosen based on process requirements and UV exposure sensitivity. The panels are made from 40 mil thick vinyl, while door panels are constructed from 80 mil thick vinyl. The panels are arranged in an overlapping fashion to provide a barrier against external contaminants.
The 40 mil vinyl panels offer enhanced durability with double the material thickness, making them resistant to tearing. They are secured to the support frame using a grip track mounting system to ensure contamination prevention.
The air treatment system is crucial for a softwall cleanroom, relying on factors such as airflow patterns, air supply, HEPA filters, and the room's air pressure. The system's classification is based on the air change rate per hour (ACH), which determines the ISO classification. Air change rates can vary from 10 times per hour to 250 times per hour, with higher rates corresponding to higher ISO classifications.
High-efficiency particulate air (HEPA) filters are the industry standard for cleanroom air treatment. HEPA filters remove 99.97% of particulate matter at 0.3 microns, including dust, pollen, animal dander, bacteria, and various contaminants. They consist of randomly placed fiberglass fibers of different densities, with the fiber diameter and thickness contributing to their efficiency.
The dense construction of HEPA filters necessitates a powerful air circulation system to effectively move air through them.
The HVAC system for a softwall cleanroom is designed to manage temperature and humidity within capacities ranging from half ton to two tons. These systems require a multi-panel design for flexible ducting to accommodate the varying needs of softwall cleanrooms. Depending on the requirements, condensers may be air or water-cooled.
Air is drawn into the HVAC system from outside the cleanroom and passes through prefilters before moving through the system and exiting through HEPA filters into the room. The air is directed vertically downward towards the floor, where it exits beneath the vinyl plastic strip walls. In certain cases, air conditioning might need to be routed from the building's HVAC system or another source.
The HVAC airflow system in a softwall cleanroom is a single-pass system, unlike solid wall cleanrooms which may use either single-pass or recirculating systems.
The level of lighting required is based on the types of processes performed within the cleanroom. This aspect must be planned well in advance to provide the appropriate illumination for the conditions. A significant challenge in designing a softwall cleanroom is positioning the lighting to avoid interfering with air movement and filtration.
Common types of lighting for softwall cleanrooms include recessed, surface mount, and teardrop. Among these, teardrop lighting can be problematic as it impacts the headroom within the cleanroom.
Recessed troffers are designed to fit into the suspended drop ceiling, ensuring a tight fit that provides excellent illumination without disrupting airflow. They sit flush along the ceiling line, allowing ample space for the plenum. Recessed troffers are commonly used in the highest classifications of softwall cleanrooms.
Surface-mounted softwall cleanroom lighting is typically used only in lower classifications of cleanrooms because it interferes with airflow. These lights are mounted directly on the ceiling and do not sit recessed, which causes disruption to the airflow.
Teardrop lighting hangs below the ceiling to allow for proper airflow. Their design avoids interfering with airflow and minimizes turbulence. However, while they do not disrupt airflow patterns, teardrop lights occupy headroom space.
Softwall cleanrooms have gained popularity in recent years due to their affordability and versatility. They are tent-like, lightweight, and easy to assemble. Their flexibility allows them to be freestanding or have ceilings suspended from a building's structure. Compared to hard wall clean rooms, they are significantly smaller and can be adapted to fit various spaces.
There are minimal differences among softwall cleanrooms as most share common features such as vinyl walls and tubular aluminum or steel frames. However, additional features can be incorporated to distinguish them beyond their basic configurations.
Some design considerations for softwall cleanroom customers include:
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 highly adaptable, allowing for easy adjustments to the cleanroom's dimensions as needed. They are cost-effective, especially when frequent changes in size may be required.
The ceiling grid for these cleanrooms is suspended from the joists of a building's ceiling. The softwalls or curtains are attached to the edges of the ceiling using hook beads, enabling them to slide along the tracks of their frame. These softwalls do not have a rigid 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 consists of tubular steel that is formed, welded, and powder-coated. To increase its strength, the tubing is tightly bolted and secured. This bolting allows for adjustments to the cleanroom's size to accommodate changes in processes or testing needs. While steel framing is heavier and more challenging to move, it is generally less expensive than aluminum framing.
One of the most appreciated features of softwall cleanrooms is their flexibility to expand and contract according to the needs of technicians. This allows users to enlarge the initial softwall cleanroom, potentially matching the size of a hardwall-built cleanroom.
For example, an 8x8x8 cleanroom can be expanded to double its size by adding an 8x12x8 extension.
Free-standing horizontal airflow softwall cleanrooms feature horizontal airflow provided by laminar flow built into the sides of the cleanroom. Air is drawn through the back of the unit and filtered through HEPA filters. This horizontal design positions the workspace closer to the filtered airflow, offering enhanced environmental conditions for specific applications.
Horizontal free-standing airflow softwall cleanrooms are utilized by life sciences, medical instrument manufacturers, pharmaceutical companies, and electronics manufacturers.
Gowning rooms are commonly found in hardwall or modular cleanrooms. In softwall cleanrooms, they can be an additional feature for higher classification setups. Gowning room curtains are attached to the ceiling grid system, creating a separate enclosed space for technicians to prepare before entering the uncontaminated cleanroom.
There are several options for the walls of a softwall cleanroom, with polypropylene, vinyl, and polyvinyl chloride (PVC) being the most common. These types of soft plastic walls are designed to insulate the cleanroom environment from contaminant intrusion. They can be easily attached and detached as needed to suit testing conditions.
Vinyl, available in various colors to suit different processes, is lightweight, easy to install, and clean. The vinyl strips come in different thicknesses, with standard panels being 40 mil and door panels being heavier and more durable. When hung, the vinyl panels overlap for added protection of the cleanroom environment. The thick vinyl strips are highly resistant to tearing and are secured to the frame with a grip track mounting system.
PVC is highly recommended for cleanrooms and areas sensitive to contaminants due to its properties and characteristics, which make it easy to clean and maintain a contaminant-free environment.
PP is chosen for applications where high purity, durability, and rigidity are essential. It resists chemical leaching and corrosion effectively and stands up well to impacts and freezing conditions. Its adaptability allows it to bond with other materials without adhesives. Additionally, its superior heat resistance makes it suitable for environments requiring autoclaving or heat treatments.
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.
Similar to other softwall materials, VCP boasts exceptional resistance to tearing and abrasion, which makes it suitable for a range of uses. This material is composed of 100% polyester and features a uniform polyvinyl chloride coating. This coating endows the polyester with properties such as fire resistance, anti-fungal protection, and UV stability. VCP's durability and strength make it a perfect choice for the demanding environment of a cleanroom equipped with softwalls.
The selection of materials like vinyl, PVC, and PP allows for tailoring to the specific conditions, uses, and tasks within a softwall cleanroom environment.
Just like rigid-walled cleanrooms, softwall cleanrooms offer various types of entry options, including overlap doors, plastic strip curtains, sliding doors, automatic rolling doors, and hinged swing doors. The type of entrance plays a crucial role in the cleanroom's classification because it impacts the level of contamination that can enter the space. To maintain higher cleanliness standards, many high-classification cleanrooms incorporate pass-throughs or gowning areas to minimize the introduction of contaminants.
Vertical airflow softwall cleanrooms are prevalent and feature a laminar flow system positioned in the ceiling. The HVAC system draws air from the external environment, channels it through HEPA filters, and then directs it down into the workspace. The filtered air exits beneath the softwalls, just above the floor level.
Softwall cleanrooms must adhere to specific ISO classification standards, which are crucial for determining their suitability. Due to their design, softwall cleanrooms cannot achieve the same level of tight sealing as rigid or hardwall cleanrooms, which limits their ability to meet the highest ISO standards.
Despite these limitations, softwall cleanrooms can still satisfy various ISO requirements, ranging from ISO 5 to ISO 8. This makes them suitable for a diverse array of industrial applications.
Cleanrooms are categorized based on the cleanliness of the air within them. This classification depends on the concentration and size of particulate matter found in one cubic meter of air. Two primary systems for cleanroom classification are the United States Federal Standard 209E (FS 209E) and the International Organization for Standardization (ISO). Both systems are commonly employed by manufacturers to indicate their cleanroom's cleanliness level.
The ISO classification system ranges from ISO 1 to ISO 9, while the FS 209E system spans from Class 1 to Class 100,000. Additionally, there are specific standards tailored to various industries, such as the EU GMP and USP guidelines.
Due to their design, softwall cleanrooms cannot achieve classifications below ISO 5 or FS 209E Class 100. However, these levels of cleanliness are generally adequate for most industries. More stringent classifications are typically necessary for industries that require extremely precise and controlled environments.
Achieving ISO 5 cleanliness standards typically involves passing through multiple stages of progressively cleaner environments, such as an ISO 8 anteroom, followed by ISO 7 and ISO 6 areas before entering the ISO 5 cleanroom. While this theoretical approach is ideal, it may not always be feasible for softwall cleanrooms. An alternative solution is to incorporate two or three additional softwall cleanrooms leading into the ISO 5 cleanroom to meet the stringent requirements.
Airflow is a critical factor in meeting ISO 5 standards for softwall cleanrooms. The standard mandates unidirectional airflow provided by HEPA filters installed in the ceiling grid. This configuration requires a high volume of air to maintain cleanliness. For rooms smaller than eight meters, horizontal airflow can be used as an alternative. However, the necessary number of filters and air handling units significantly increases the cost of maintaining the required airflow.
The recommended air exchange rate for an ISO 5 softwall cleanroom is between 240 and 360 changes per hour.
To achieve an ISO 6 classification, a softwall cleanroom generally needs one or two airlocks before entry. The specific number of airlocks required can vary based on the room’s dimensions, the types of processes conducted, and the number of occupants. While unidirectional airflow is ideal, it may not be mandatory for rooms smaller than four to six meters in width. The air exchange rate for an ISO 6 softwall cleanroom typically ranges from 90 to 180 changes per hour.
ISO 7 cleanrooms are among the most frequently used classifications across various industries, such as clinical manufacturing, electronics, and nutraceuticals. An ISO 7 softwall cleanroom typically has an air exchange rate ranging from 30 to 60 changes per hour and maintains a particle count of up to 352,000 particles per cubic meter for particles of 0.5 μm in size.
ISO 8 softwall cleanrooms generally do not require an airlock or preceding chamber for access to the main workspace. However, some may include a gowning room depending on the specific applications and work being conducted. ISO 8 cleanrooms typically have an air exchange rate of 15 to 25 changes per hour. The more lenient standards of ISO 8 allow for their use in various sectors, including certain pharmaceutical and medical device manufacturing, as well as the automotive industry.
The chart below provides a comparison of ISO standards for softwall cleanrooms alongside their FS 209E equivalents.
| ISO Cleanroom Standards and The FS 209E Equivalent | ||||||||
|---|---|---|---|---|---|---|---|---|
| ISO Class | Maximum Particles/m3 | Particles/ft3 | FS 209E Equivalent | |||||
| ≥0.1μ | ≥0.2μ | ≥0.3μ | ≥0.5μ | ≥1μ | ≥5μ | ≥0.5μ | ||
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | 100 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | 1000 | Class 1,000 |
| ISO 7 | 352,000 | 83,200 | 2,930 | 10,000 | Class 10,000 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | 100,000 | Class 100,000 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 | |||||
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.
As it applies to controlling particles, softwall cleanrooms are flexible, controlled environments that can be used anywhere hardwall cleanrooms are used, which cannot be said of hardwall cleanrooms.
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.
There are several industries where softwall cleanrooms are used in place of hardwall cleanrooms including:
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.
Softwall cleanrooms are designed to meet the same particle levels of hardwall cleanrooms. It is believed that since the vinyl wall panels hang loose from the frame, it is hard for softwall cleanrooms to meet static pressure requirements of more than 0.009 inch. It is assumed that the vinyl panels slightly bellowing out from the air pressure allows air to escape under the curtains and allow unclean air in. After testing, the velocity of the air exiting under vinyl panels does not allow for unfiltered air to enter a softwall cleanroom.
It is errantly believed that softwall cleanrooms have a single pass design where 100% of the air being introduced into the room through the filters immediately exits the room at the floor and controlling the temperature and humidity is more difficult and expensive than a partial recirculating system.
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