What are Softwall Cleanrooms and How Do They Work?

According to Polaris Market Research, in 2020, the global cleanroom technology market was worth USD 5.08 billion, and it is anticipated to increase at a compound annual growth rate (CAGR) of 5.0% throughout the projection period.

The demand for cleanrooms is being driven by the need for safe and high-quality healthcare products as well as environmental concerns. Additionally, the rising demand for sterilized pharmaceutical products, as well as the safety and hygiene of personnel working in the industry, is boosting the cleanroom technology market.

Softwalls are a type of cleanroom wall that uses less material than traditional walls but still has the same level of containment and is capable of achieving higher cleanliness levels. This means that softwall cleanrooms can help you save money on construction costs while still providing the same level of protection from contamination as other types of walls.

Let’s take a look at how softwall cleanrooms work and why they’re so effective.

Definition and Types

Softwall cleanrooms are constructed using flexible materials like vinyl or polyurethane and are characterized by their modular and adaptable design. T

A softwall cleanroom assembly can come in many types, including portable cleanrooms, freestanding cleanrooms, and modular cleanrooms. Portable cleanrooms can be moved around easily and are typically used for small-scale applications, while freestanding cleanrooms are self-supporting and can be customized to meet specific requirements. Modular cleanrooms are the most versatile and can be easily expanded or modified to accommodate changing needs.

According to American Cleanroom Systems, a provider of cleanroom technology, Softwall cleanrooms are simple to assemble, as they generally do not require flooring, electrical or AC installation, or connection to an existing building. Additionally, smaller softwall cleanrooms can be fitted with casters, allowing for easy movement around a factory or other space.

Contamination Control

According to Cleanroom Technology, cleanroom classification ratings vary depending on the number and size of particles allowed per volume of air and range from 1 to 100,000. However, industries such as semiconductors, microelectronics, and medical device/pharmaceutical manufacturing require the most stringent cleanroom standards.

To reduce all sources of contamination, specific processes must be implemented, and products designed to meet specific cleanliness standards must be used. Contamination can occur unexpectedly from various sources, including materials, equipment, people, and consumables like tapes or paper-based products that shed particulates.

Contamination control is crucial in softwall cleanrooms to ensure that the environment remains sterile and free from any particles that may contaminate the products being manufactured or tested within.

To control contamination, various measures are taken, such as proper ventilation systems, HEPA filtration, and routine cleaning protocols. Additionally, operators must wear proper attire, such as cleanroom suits, gloves, and masks, to prevent any particles from entering the cleanroom.

Regular maintenance and inspection of equipment and machinery are also important to ensure that they do not contribute to contamination.

Components and Assembly

Softwall cleanroom assembly consists of several essential components, including the frame, wall panels, and ceiling panels. The frame serves as the structural support for the cleanroom, and the wall panels and ceiling panels are attached to the frame.

The wall panels are typically made of PVC curtains or vinyl strips, and the ceiling panels are made of clear vinyl material. Proper sealing of the panels is critical to ensure a contamination-free environment.

The panels must be securely attached to the frame to prevent gaps or openings that can allow contaminants to enter the cleanroom. The importance of proper sealing cannot be overstated, as even small gaps can compromise the effectiveness of the cleanroom.

Cleanliness Levels

According to News Medical Life Sciences, a cleanroom classified under ISO 14644-1 is a controlled environment where maintaining low particle counts is critical. Cleanrooms are classified from ISO 1 to ISO 9, depending on the maximum allowable particle concentration per cubic meter or cubic foot. ISO 9 is one of the lower classifications and is considered to be less clean compared to other classifications.

Softwall cleanrooms can achieve ISO Class 6 to Class 9 cleanliness levels, making them suitable for industries such as electronics, medical devices, and biotech.

The cleanliness level of a softwall cleanroom is determined by factors such as air filtration, air pressure, and the materials used for construction. Softwall cleanrooms can be designed and constructed to meet the specific cleanliness requirements of different industries and applications.

Advantages

Softwall cleanrooms offer several advantages over traditional hardwall cleanrooms. One of the main advantages is cost-effectiveness, as softwall cleanrooms are typically less expensive to construct and maintain than hardwall cleanrooms.

Softwall cleanrooms are also highly flexible and can be easily modified or relocated to accommodate changing needs. They are relatively easy to install and can be set up in a short amount of time.

Additionally, softwall cleanrooms can be designed to meet various cleanliness levels, making them suitable for a wide range of industries and applications.

Disadvantages

Despite the advantages of softwall cleanrooms, there are some potential disadvantages to consider. Softwall cleanrooms may have lower cleanliness levels than hardwall cleanrooms, as they are typically not as airtight and may allow more contaminants to enter the controlled environment.

Additionally, softwall cleanrooms may not provide as much noise reduction as hardwall cleanrooms, which can be a concern in certain industries. Finally, softwall cleanrooms may have decreased insulation compared to hardwall cleanrooms, which can affect temperature and humidity control.

Applications

Softwall cleanrooms are suitable for a variety of industries and applications, including pharmaceuticals, biotech, electronics, and research laboratories. These industries have unique requirements for cleanliness and contamination control, and softwall cleanrooms can be designed to meet these needs.

In the pharmaceutical industry, softwall cleanrooms are used for manufacturing drugs and medical devices, as well as for research and development. In the biotech industry, softwall cleanrooms are used for the production of biologics and other sensitive products.

In electronics manufacturing, softwall cleanrooms are used to prevent contamination during the assembly of electronic components. Research laboratories also use softwall cleanrooms for a variety of applications, including microbiology and cell culture.

Regulations and Standards

Softwall cleanrooms are subject to various regulatory requirements and standards to ensure their effectiveness and safety. ISO cleanroom standards provide guidelines for the design, construction, and operation of cleanrooms to achieve desired cleanliness levels.

The FDA regulates softwall cleanrooms used in pharmaceutical and medical device manufacturing and requires adherence to current Good Manufacturing Practices (cGMPs). GMP requirements ensure that products are consistently produced and controlled to meet quality standards.

Other regulatory agencies, such as the European Medicines Agency (EMA), also have requirements for softwall cleanrooms. Compliance with these regulations and standards is essential for industries that use softwall cleanrooms to maintain the integrity and safety of their products.

Conclusion

Softwall cleanrooms are a great option for those who want to take advantage of all the benefits that come with traditional cleanrooms but don’t have the space or budget for them. They’re also perfect if you need an area that can be easily modified or reconfigured to meet changing needs over time.

Softwall cleanrooms work just like their hard-walled counterparts, except they use fabric instead of concrete walls, which allows them to be built quickly and cheaply without sacrificing quality or durability.