This article contains concise information regarding portable cleanrooms and their use.
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Portable or modular cleanrooms are pre-built, independent systems requiring only electrical power and cooling to function. Depending on the design, they can usually be delivered within 4-8 weeks and are engineered for quick setup, typically taking between one to three weeks to assemble.
The prefabrication of these cleanrooms contributes to swift installation, greatly minimizing operational interruptions and the risk of contamination. As these cleanrooms are crafted and manufactured at the factory, the usual need for architects, engineers, or general contractors is often eliminated, leading to valuable savings in both time and expenses.
Some portable cleanrooms come with wheels or casters for easy movement, while others are divided and shipped in sections on pallets. Once disassembled, transported, and reassembled, 90-95% of their components are reusable. This reusability boosts the cost-effectiveness of portable and modular cleanrooms, with certain styles, like modular hardwall systems, qualifying for accelerated depreciation benefits.
These cleanrooms are constructed to comply with ISO cleanliness levels ranging from 8 to 5, or Federal Standard Class 100 to 100,000. While they function as standalone units, they can also be employed to create clean zones and sanitized workspaces within existing cleanrooms. This flexibility makes them particularly suited for research, development, and product innovation. Portable and modular cleanrooms are compact, mobile, economical, and supply impeccably clean and filtered air, ensuring a controlled, uncontaminated, and hygienic environment.
The main purpose of portable and modular cleanrooms is to manage airborne particles like dust, microbes, aerosol particles, and chemical vapors, ensuring adherence to set limits and standards. Regardless of the design, HEPA filters are crucial in every cleanroom. HEPA filters capture particles as minute as 0.3 microns, with an efficiency of 99.97%. To visualize, 1 micron is about 1/25 of an inch or 0.04 inch, and 1/3 micron is roughly 1/75 or 0.001 inch. HEPA filters ensure the air continues to be free from contaminants and pathogens.
For areas necessitating exceptionally stringent standards, such as ISO 3 or Federal Standard Class 10, ultra-low particulate air (ULPA) filters may be utilized. ULPA filters effectively eliminate 99.9995% of particulates as small as 0.12 microns. Though ULPA filters may appear similar to HEPA filters, the distinction lies in the filter media employed. Nevertheless, both ULPA and HEPA filters aim to sustain ultra-clean air by capturing airborne contaminants.
Cleanrooms are essential in the scientific, pharmaceutical, biotechnology, and electronics industries, playing a crucial role in the development, testing, and research of sensitive technical equipment, medicines, chemicals, and substances that require protection from airborne contaminants, dust, and particulate matter. Because the environment inside a cleanroom must be stringently controlled, every aspect of cleanroom design and construction receives meticulous attention to uphold regulatory compliance and product quality.
In recent years, portable and modular cleanrooms have become increasingly popular due to their cost-effectiveness, flexibility, and rapid installation compared to traditional stick-built cleanrooms. Portable cleanrooms come in various sizes—ranging from small mobile units to modular cleanroom systems that can be quickly expanded or reconfigured to accommodate evolving production needs or changing cleanroom classification requirements. Many modular cleanroom designs incorporate an open plenum to enable flexible ISO classification upgrades. Portable and modular cleanrooms are also highly customizable, with options such as ESD (electrostatic discharge) or static-dissipative surfaces, chemical- and corrosion-resistant materials, antimicrobial finishes, and UV protection. This adaptability makes portable cleanrooms ideal for controlled environments in cleanroom manufacturing, laboratory research, and medical device assembly.
Determining the appropriate cleanroom classification and rating is a foundational step in the installation and validation of a new cleanroom environment. Portable and modular cleanrooms must adhere to the same ISO standards and particle count thresholds as traditional stick-built structures. Cleanroom validation involves testing and certifying the clean space according to rigorous standards for specific particle sizes and concentrations per designated air volume.
ISO 14644-1 standards mandate a 1-minute sample of 1 cubic meter of air for airborne particle measurement. In contrast, the now-obsolete Federal Standard 209E employed 1 cubic foot sampling, requiring conversion for modern compliance—particle counts per cubic foot are multiplied by 35.315 to reach the cubic meter standard. ISO 14644 defines cleanroom classes from ISO 1 (the cleanest) to ISO 9 (least clean), but most portable cleanrooms fall between ISO 5 and ISO 8, depending on application and risk assessment. Medical device manufacturing, semiconductor production, and nanotechnology typically demand lower ISO class levels for heightened contamination control.
Although Federal Standard 209E is outdated, many industries still reference it alongside ISO standards for clarity during purchasing, regulatory review, or customer audits. The table below provides a comparison of allowable particle sizes and counts for both systems, aiding facility managers in selecting the correct portable cleanroom solution for their critical environment requirements. Lower classification numbers indicate cleaner environments in both systems, with ISO 3 or Class 1 reserved for highly sensitive work.
When evaluating cleanroom options or preparing for cleanroom validation, industry professionals must also consider end-user specifications, regulatory mandates (such as FDA or GMP compliance), and specific process or product sensitivities. Requirements may differ significantly depending on whether the cleanroom supports pharmaceutical sterility, electronics manufacturing (where ESD and particle control are paramount), or research and biotechnology applications.
| ISO and Federal Standard 209E Classifications | ||||||
|---|---|---|---|---|---|---|
| Class | Max. Particles/ft³ | ISO Equivalent | ||||
| ≥0.1μ³¾ | ≥0.2μ³¾ | ≥0.3μ³¾ | ≥0.5μ³¾ | ≥5μ³¾ | ||
| 1.00 | 35 | 7.5 | 3 | 1 | 0.007 | ISO 3 |
| 10.00 | 350 | 75 | 30 | 10 | 0.07 | ISO 4 |
| 100.00 | 3500 | 750 | 300 | 100 | 0.7 | ISO 5 |
| 1,000.00 | 35000 | 7500 | 3000 | 1000 | 7 | ISO 6 |
| 10,000.00 | 350000 | 75000 | 30000 | 10000 | 70 | ISO 7 |
| 100,000.00 | 3500000 | 750000 | 300000 | 100000 | 700 | ISO 8 |
Choosing the right cleanroom classification is vital for contamination control, regulatory compliance, and maintaining product integrity. Consulting with an experienced cleanroom manufacturer or ISO certification specialist can help determine the correct environment for your application.
Maintaining temperature and humidity control in a cleanroom is critical for process stability, minimizing microbial growth, and ensuring optimal equipment operation. The ideal environmental parameters are dictated by the end-use application: for instance, pharmaceutical manufacturing and sterile compounding require stringent temperature and relative humidity (RH) limits to prevent bacterial proliferation, while electronics or semiconductor cleanrooms must control static and material outgassing.
In many standard applications, precise control is not mandatory, and ambient conditions are sufficient. In more advanced or regulated environments, however, temperature is set between 67 to 69 °F (19.4 to 20.6 °C), and humidity levels are maintained below 60% RH to ensure compliance with GMP, USP <797>, or other manufacturing standards. Recirculation of filtered air using integrated HVAC and HEPA filtration systems is the cornerstone of energy-efficient temperature and humidity control, reducing operational costs and maintaining air cleanliness. In specialized setups—such as microelectronics assembly—supplemental dehumidification and airlock entry systems may be required to manage external air quality and prevent cross-contamination.
If recirculation is not feasible and intake air is drawn from ambient sources, each filtration unit may require its own dedicated HVAC system, resulting in higher operating expenses. For softwall cleanrooms, which employ non-recirculating airflow, advanced climate control options are limited, making them less suitable for temperature or humidity-sensitive applications.
Portable cleanrooms utilize an array of panel designs tailored to the application’s cleanliness requirements and operational environment. The panel system forms the barrier to keep out particulates, microorganisms, and airborne contaminants commonly found in laboratory, production, and assembly areas. Panel material selection determines ISO classification feasibility, chemical resistance, and long-term durability.
Softwall cleanroom panels are constructed from flexible PVC, antistatic vinyl, or polyurethane, enabling the configuration of temporary or portable cleanroom spaces with rapid installation. They serve as barriers against particulate ingress, commonly used as internal dividers or entry vestibules and are ideal for achieving ISO 7 or ISO 8 classifications. Softwall cleanrooms provide a cost-effective solution for microbiology labs, electronics assembly, and pharmacy compounding environments requiring moderate contamination control.
Rigid clear panels, typically manufactured from acrylic, polycarbonate, or antistatic PVC, merge the visibility and strength of hardwall cleanrooms with the easy assembly characteristic of portable systems. Rigid panels enable portable cleanrooms to achieve higher ISO ratings—from ISO 5 to ISO 8—suitable for environments such as semiconductor manufacturing, medical device fabrication, and nanotechnology labs. The transparent design supports process observation while facilitating monitoring of personnel workflows, equipment, and product handling.
Additionally, rigid wall panels support greater internal air pressure for superior particulate control, managed via adjustable wall dampers and integrated filtration. When comparing rigid panel cleanrooms versus softwall cleanroom systems, the choice depends on cleanroom classification requirements, durability, and process sensitivity.
Maintaining sanitation and structural integrity at every stage of construction is essential in portable cleanroom installation. The framework supports the entire modular enclosure, providing both flexibility for mobility and robust strength for panel sealing and alignments.
Modern portable cleanrooms are engineered with extruded aluminum or powder-coated steel framing. These modular frames are designed with knock-together or bolt-together corners, facilitating seamless relocation, easy expansion, and replacement of individual wall or ceiling panels as needed. This modular approach improves lifecycle value and supports ongoing compliance with evolving ISO or FDA cleanroom standards.
Ceiling grids in portable cleanrooms work seamlessly with rigid or flexible panels to create a fully enclosed controlled space, ensuring minimal air leakage and strict particulate exclusion. These grids are engineered to support essential equipment, such as modular light fixtures, HEPA or ULPA filter units, and fan filter units (FFUs). Cleanroom ceiling grids may be manufactured in anodized aluminum, stainless steel, or powder-coated steel, assembled using locking fasteners for rapid deployment and fitment to project specifications.
Lighting design in a portable cleanroom directly impacts both productivity and contamination control. Portable cleanrooms require uniformly distributed, glare-free illumination that meets precise ISO classification and process requirements. Common cleanroom lighting solutions include recessed fluorescent, LED, and high-density discharge fixtures, each selected for energy efficiency, low heat output, and minimal particle emission. White, reflective surfaces on walls and ceilings optimize light dispersion—improving visibility for precision assembly, laboratory inspection, and quality assurance.
Many cleanroom lighting systems incorporate UV disinfection lamps or UVC germicidal irradiation to reduce microbial load and enhance sterility compliance. Increasingly, LED lighting is favored for its energy savings, longevity, ease of cleaning, and environmentally friendly characteristics. Choosing the right lighting solution is a key specification in cleanroom design and build projects.
High Efficiency Particulate Air (HEPA) filtration is a cornerstone of contamination control for portable and modular cleanrooms. HEPA filters remove at least 99.97% of particles sized 0.3 microns or larger—a critical specification for achieving and maintaining most cleanroom ISO classifications. Medical, microelectronics, and pharmaceutical cleanrooms often require HEPA or even ULPA (Ultra-Low Particulate Air) filters for stringent air cleanliness.
Cleanroom HEPA filter systems are commonly ceiling-mounted or integrated into fan filter units (FFUs) to provide vertical or horizontal laminar airflow. Regular filter integrity testing, including leak tests and airflow validation, is necessary to ensure compliance with ISO 14644-3, cGMP, and FDA standards. Proactive filter maintenance and periodic replacement keep particle counts below critical thresholds and safeguard sensitive processes and products.
Filter Fan Units, or FFUs, are compact modular assemblies combining an efficient fan, pre-filter, and HEPA (or ULPA) filter within a single housing for easy cleanroom integration. FFUs are fundamental to creating ISO-classified portable cleanrooms, providing clean, filtered airflow with minimal vibration and acoustic disturbance. Depending on cleanroom area and target classification, one or multiple FFUs may be deployed to provide uniform particle removal and maintain positive pressure environments.
Well-designed FFUs allow for scalable cleanroom upgrades, easier filter maintenance, and optimal air change rates—vital for compliance with ISO 14644, cGMP, and USP <797> guidelines. FFU selection and configuration are critical purchasing considerations, impacting not only air cleanliness but also operational noise levels, energy efficiency, and overall cleanroom lifecycle cost.
The flooring in a portable cleanroom must meet stringent surface cleanliness, durability, and safety requirements to maintain regulatory compliance and support ongoing controllable operations. Typical cleanroom floors utilize seamless vinyl, conductive PVC, static-dissipative rubber, or perforated tiles to meet ISO and industry-specific GMP validation standards. A raised modular floor, often called “loose lay� flooring, enables easy expansion, reconfiguration, or site relocation while maintaining a continuously clean, non-porous, and sanitize-ready finish.
In environments handling sensitive electronics or static-sensitive materials, flooring often features integrated ESD (electrostatic discharge) protection layers, grounded to control static buildup and prevent damage to products or processes. Non-slip surfaces, autoclavable mats, and sticky entrance mats further reduce the risk of particulate ingress or cross-contamination. Selecting the right cleanroom flooring solution should account for load-bearing requirements, rolling equipment, and frequency of chemical or disinfectant use.
Workplace safety and ergonomic considerations are paramount: anti-fatigue and antimicrobial mats enhance staff comfort, productivity, and compliance with occupational safety regulations. Consulting cleanroom flooring experts ensures optimal performance, hygiene, and lifespan for your portable cleanroom environment.
Modern portable cleanrooms are delivered with fully prewired electrical systems for speedy on-site deployment, eliminating the need for extensive electrical rework or skilled electricians during assembly. Once assembled, cleanroom modules simply connect to an existing commercial or industrial power supply—the majority utilize standard 120/208V three-phase systems rated for HVAC, lighting, and essential process automation equipment. For critical environments or continuous operation, portable cleanrooms can be equipped with integrated backup power solutions, such as generators or uninterruptible power supply (UPS) units, to safeguard against service disruptions and maintain consistent air quality control during power outages.
Electrical safety, grounding, and circuit protection are critical engineering considerations, particularly in ESD-sensitive cleanrooms, laboratory research spaces, and pharmaceutical manufacturing suites. Ensuring compliance with NEC, NFPA, and local building codes supports long-term safety and regulatory approval for your portable cleanroom installation.
When evaluating different portable cleanroom options, it is important to align your selection with user intent, operational needs, and regulatory expectations. Key purchasing considerations include intended cleanroom application (such as pharmaceutical compounding, microelectronics, biomedical research, or food processing), target ISO classification, future scalability, energy efficiency, ease of maintenance, and ongoing compliance documentation. Collaborating with experienced cleanroom manufacturers and considering onsite assembly support, customizable features, and validation services can streamline your procurement process and ensure a successful installation tailored to your facility’s needs.
Many leading cleanroom companies offer pre-engineered modular designs, comprehensive warranty coverage, and robust after-sales support. Requesting detailed quotes, performance specifications, and references during your evaluation process can help ensure you secure a high-performance, compliant portable cleanroom solution that will protect your processes and products now and in the future.
The main distinction between portable cleanrooms lies in the types of walls they feature: those with rigid, solid walls versus those with soft plastic walls. Another way to categorize cleanrooms is based on their function, which can range from patient diagnosis to the testing and research of chemicals and medicine.
Furthermore, portable cleanrooms can be classified by factors such as size, portability, suitability for indoor or outdoor use, and their ISO or Federal Standard 209E classifications. Like all cleanrooms, portable ones are meticulously designed to meet the specific needs and requirements of their intended applications.
Soft wall cleanrooms provide a flexible, mobile, efficient, and cost-effective way to establish a controlled clean air environment quickly. Designed to convert any space, regardless of location, into a high-performance cleanroom, these units are as robust, durable, and resilient as traditional cleanrooms, despite their softer walls.
The frames of soft wall cleanrooms come in various materials, including lightweight aluminum, stainless steel, or heavier steel options. They are coated with a powder finish that prevents corrosion and contamination from the surrounding environment.
Like all cleanrooms, portable soft wall cleanrooms are equipped with HEPA fan filtration systems to meet rigorous ISO 4 to ISO 8 standards. Additionally, many feature LED lighting panels, known for their energy efficiency and long-lasting performance, adding to the overall cost-effectiveness of the setup.
Rigid wall portable cleanrooms offer the same flexibility and high performance as soft wall cleanrooms. The key difference lies in their wall system, which is constructed from sturdy materials, including various forms of clear plastics, providing greater strength and durability.
These less permanent rigid wall cleanrooms serve as a middle ground between solid hard wall cleanrooms and soft wall options. While the panels are non-porous, firm, and resilient, they can be easily disassembled and reassembled, allowing for economical and efficient adjustments in size based on evolving needs and business demands.
Unlike permanent cleanrooms that depreciate over 39 years, rigid wall portable cleanrooms can be depreciated as an expense over seven years. They meet ISO classifications ranging from ISO 4 to ISO 8, providing a cost-effective solution for achieving these standards.
As with all cleanrooms, rigid wall portable cleanrooms are equipped with airflow fan filter units that feature HEPA filtration systems to ensure compliance with ISO standards. Additionally, the wall panels are finished with white baked enamel to seal them and prevent contamination.
Bio-clean cleanrooms are semi-rigid structures designed to address the specific needs of the medical industry in managing microbial contaminants, as well as the particulate requirements of the electronics, aerospace, and high-tech sectors. Like other modular and portable cleanrooms, bio-clean cleanrooms offer easy expandability to adapt to the evolving needs of both medical and technical fields.
With their prefabricated design, bio-clean cleanrooms enable quick, efficient, and straightforward installation without requiring significant modifications to the existing space. These cleanrooms are also highly customizable, allowing them to be tailored to meet the unique requirements of each customer's business and operational needs.
A notable innovation in portable and flexible cleanrooms, emerging from the COVID-19 pandemic, is the isolation medical exam pod. These pods are designed to facilitate the testing and examination of workers and patients, minimizing the risk of exposing others to potentially hazardous conditions. They feature seamless flooring for effective cleaning and surface disinfection.
Similar to larger cleanrooms, isolation medical exam pods are equipped with HVAC systems that include HEPA filters and overhead lighting to ensure adequate ventilation and illumination. Their compact size makes them easy to install, and they come with self-contained electrical systems and condenser units.
Often referred to as alternative care facilities for infection control, isolation medical exam pods were primarily developed in response to the COVID-19 pandemic. However, they are also increasingly utilized in industrial settings to address illnesses or injuries occurring on the job.
The post and panel design of a portable cleanroom offers several compelling advantages, making it a popular choice. This design allows for easy reconfiguration, adjustment, and expansion of the cleanroom to adapt to a company’s evolving needs.
Post and panel cleanrooms feature four-foot panels and stud posts that can be dismantled into two pieces. This design enables the removal and replacement of individual panels without disrupting the others. All components of a post and panel cleanroom are reusable or storable. The system includes built-in raceways for convenient access to utilities, ensuring the cleanroom's classification remains intact.
The panels of a post and panel portable cleanroom can be made from various materials, including vinyl, melamine, laminate, reinforced fiberglass, stainless steel, aluminum, or steel, with cores of polystyrene, polyisocyanurate, fiberglass, or honeycombed aluminum. Like other portable cleanrooms, post and panel cleanrooms can be installed either inside or outside a building, depending on the specific needs and requirements of the customer.
In recent years, there has been a notable shift from constructing permanent cleanrooms to utilizing portable, adjustable, and adaptable cleanrooms that can be tailored to meet business needs. This change is driven by the efficiency and significantly lower cost of portable cleanrooms.
As technology advances, industrial companies increasingly require exceptionally clean and uncontaminated environments for various assembly and manufacturing processes. This growing demand has expanded the market for portable cleanrooms and led to the emergence of cleanroom rental organizations that cater to temporary installation needs.
One of the key advantages of portable cleanrooms is their ability to quickly adapt to the changing demands and requirements of various processes, operations, or applications. While many industries that require sanitized conditions already have permanent facilities to handle their production needs, there are instances where rapid adjustments to infrastructure are necessary to accommodate increased demand. In such cases, portable cleanrooms offer an ideal solution.
Permanent cleanrooms have long been essential for the production and manufacturing of medicines, ointments, and medical instruments. The hygienically uncontaminated conditions they provide are required by the Food and Drug Administration (FDA) to ensure the safety and efficacy of pharmaceutical products for consumers.
When additional space or isolation for a research procedure is needed, portable cleanrooms offer a quick, easy, and flexible solution that can be set up and utilized in a short timeframe. They have become a crucial component in the production and distribution efforts of the COVID vaccine.
For high-tech industries, maintaining ultra-clean environments is essential due to the delicate and sensitive nature of their products. As production needs and demands for technical products can change rapidly, immediate adjustments to production facilities are often required. Portable cleanrooms offer an ideal solution, seamlessly integrating into technical processes and providing the perfect ISO-qualified environment for these industries.
Traditionally, many manufacturing and industrial operations did not require spotless and uncontaminated environments. These operations typically relied on heavy machinery and complex assembly processes managed by advanced technical devices.
However, with the advent of the computer age, industrial organizations have increasingly recognized the need for cleanrooms to handle processes that demand uncontaminated conditions. Since such conditions are not commonly required, manufacturers often use portable cleanrooms to bridge the gap and meet the specific needs of a design or process.
In the food industry, where public consumption is a primary concern, the FDA closely monitors production processes to ensure food products are produced in hygienically sanitized conditions. Consequently, food producers often maintain permanent cleanrooms to support their regular production needs.
When faced with sudden spikes in demand or shifts in consumption, food producers require a swift and convenient method to expand their operations. To address this need, they rely on the flexibility and adaptability of portable cleanrooms, which can quickly adjust to changing requirements.
Cultivation processes require cleanrooms that can be rapidly set up and adjusted while providing the necessary protection for products during their growth cycle. Portable cleanrooms meet these standards, offering the required flexibility and secure sealing. Unlike other industries, the cultivation sector needs cleanrooms with load-bearing capabilities to support the weight of racks and products. Therefore, portable cleanrooms designed for this industry are built with substantial strength to handle these loads effectively.
The rapid expansion of the portable cleanroom industry has highlighted the need to assess their benefits and ensure they are maintained properly for optimal performance. Portable cleanrooms have become essential tools for various industries, providing adaptable solutions to create uncontaminated environments.
Worker care and safety are crucial in all work conditions, particularly in cleanroom environments. By following straightforward maintenance practices, a portable cleanroom can remain a valuable asset, delivering reliable performance and longevity.
Of all the various tools and equipment available to meet the needs of modern industry, portable cleanrooms are one of the most beneficial, pliable, resilient, and convenient. Their benefits include:
Safe operation and effective control of a portable cleanroom are vital for safeguarding employees, products, processes, and applications. It is important to implement necessary safety protocols and procedures before or during the installation of a portable cleanroom. Employees should receive comprehensive training and clear instructions on how to ensure their own safety and maintain the integrity of the products and processes.
Key safety procedures include:
These safety procedures are general guidelines and should be tailored to suit the specific conditions and environment of each company. Since every portable cleanroom installation is unique and customized, adapting these procedures to fit the particular requirements of the installation is essential.
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