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 play a crucial role in the development, testing, and research of sensitive technical equipment, medicines, chemicals, and substances that must be protected from contaminants and particulate matter. Given the critical nature of their work, the construction of cleanrooms demands meticulous attention to every detail.
Portable and modular cleanrooms have gained popularity due to their cost-effectiveness, convenience, and rapid installation. They come in various sizes and can be expanded or reconfigured as needed. Many designs feature an open plenum for flexible classification changes. Additionally, portable and modular cleanrooms can be customized to meet specific requirements, including ESD or static-dissipative surfaces, chemical and corrosion-resistant materials, and UV protection.
The desired rating and classification for a cleanroom have to be determined prior to its assembly and construction. Portable/modular cleanrooms are rated, tested and classified the same as stick built rooms according to a preset number of specific particle sizes in a specified volume of air.
ISO standards require a 1-minute sample of 1 cubic meter of air for particle measurement. In contrast, the outdated Federal Standard 209E used a 1-minute sample of 1 cubic foot of air. Today, particle counts from a 1 cubic foot sample can be converted to a 1 cubic meter sample by multiplying by 35.315. The primary difference between these standards lies in their particle size values. Companies purchasing cleanrooms must adhere to the performance standards and requirements set by their customers and regulatory agencies.
Although Federal Standard 209E is now obsolete, it is still referenced alongside ISO standards for cleanroom classification. While ISO ratings are intended to replace Federal Standard 209E, the conversion between the two standards makes it convenient for many companies to use both. Federal Standard 209E classifies cleanrooms from 1 to 100,000, whereas ISO classifies them from ISO 3 to ISO 8. Lower numbers in both systems indicate cleaner environments.
The main difference between the two systems lies in their numbering: Federal Standard 209E classifies cleanrooms from 1 to 100,000, whereas ISO standards classify cleanrooms from ISO 3 to ISO 8. In both systems, lower numbers represent cleaner environments. The chart below provides a comparison of allowable particle sizes and counts for each system. Federal Standard 209E classifications are shown on the right, and ISO classifications are on the left. Although the particulate standards are essentially similar, the numbering systems differ.
| 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 |
The requirements for temperature and humidity control in a cleanroom depend on its intended use. In many cases, precise control of temperature and humidity is unnecessary and can be limited to specific applications where ambient conditions are sufficient. For instance, if the comfort of personnel or the nature of the process demands a different temperature or humidity level, recirculating the air is often the most efficient and cost-effective solution. This process involves directing the majority of the air back to the filters, while a smaller portion is redirected to the HVAC unit, which then mixes with a minimal amount of outside make-up air.
In cases where air cannot be easily recirculated and the intake to filters is exposed to ambient air, the air to each filter needs to be supplied by an independent HVAC unit, which can be very costly. Depending on the area where a cleanroom is installed, the air above the intake on the filter can be several degrees warmer than at the thermostat. To keep personnel comfortable in smocks and hair nets, the temperature in the room should be 67 to 69 °F (19.4 to 20.6 °C). Recirculating airflow can be designed into hard wall and rigid wall cleanrooms. Softwall cleanrooms have non-recirculating airflow and are unsuitable for temperature and humidity control.
Portable cleanrooms come in various panel designs, which can be either soft or hard, depending on the specific requirements of the application and the materials being tested or researched. Additionally, the panels can be constructed from different materials to suit diverse needs and operational environments.
Softwall panels are versatile and commonly used as internal dividers or flexible entry and exit points within a cleanroom. They provide effective barriers against the external environment with minimal openings. Softwall panels are also suitable for creating fully portable cleanrooms that meet ISO classifications of 7 or 8.
Rigid clear panel portable cleanrooms combine the durability of hard wall cleanrooms with the affordability of soft wall options. They offer the flexibility to be easily repositioned as needed, and are available with ISO classifications ranging from ISO 5 to ISO 8. These cleanrooms are typically constructed from acrylic or antistatic PVC.
The transparent nature of the clear PVC panels facilitates easy observation of cleanroom activities, as the panels are similar to glass in appearance. Additionally, the rigid wall panels enable the cleanroom to maintain higher internal pressure, which is controlled by variable wall dampers that manage the airflow out of the room.
Ensuring sanitation at every step of constructing a portable cleanroom is crucial. The framework is essential as it must be flexible enough for mobility and reassembly, yet sturdy enough to support the panels and ensure a tight, secure seal.
Portable cleanrooms are built with a rigid steel or aluminum frame that provides the necessary strength and rigidity. The framework features knock-together corners, allowing for the replacement of individual panels without needing to replace the entire unit.
Ceiling grids, as with the panels and framework, are designed to seal the room and keep out contaminates. Added to the requirements of the ceiling grid is its ability to support light fixtures, filters, and airflow units. Ceiling grids can be made of structural steel or aluminum and are assembled using nuts, screws, and bolts for quick and easy installation. Since every portable cleanroom must fit the user’s needs, ceiling grids are designed to fit the space and conditions.
The choice of light fixtures for a portable cleanroom depends on the desired ISO classification, the room's size, and the ceiling design. Lighting is the least expensive component in a cleanroom, consuming less than 1% of the total energy cost. It must meet the specific needs of the room’s instrumentation and function, with illuminance levels ranging from 300 lux to 1200 lux based on the room’s requirements.
Portable cleanrooms typically feature white walls that enhance lighting quality by reflecting light. All surfaces, including ceilings, floors, and walls, are white, which helps maximize light reflection. Common lighting options include incandescent, high-density discharge, and fluorescent lamps. Fluorescent lamps are especially favored for their high energy efficiency, low maintenance, and long lifespan.
High ultraviolet light is often included in cleanroom lighting to reduce bacteria and contaminants. Light-emitting diode (LED) lights are becoming increasingly popular due to their longevity, efficiency, and environmental benefits.
High efficiency particulate air (HEPA) filters are the norm for portable cleanrooms since they can trap extremely small particles. They capture and remove particulate matter that is smaller than 0.3 μ. Filters that are classified as HEPA quality are tested to prove that they can trap 99.97% of particulates. Though there are significant standards for HEPA filters, in many cases, they can capture particles that are smaller than 0.3 μ.
In portable cleanrooms, the filtration system is integrated into the ceiling as part of the air handling setup. Despite the high efficiency and stringent standards of HEPA filters, they require regular testing to ensure their integrity and performance. This assessment involves checking the filters for leaks and other issues that could compromise the cleanliness of the cleanroom.
Filter fan units (FFUs) are stand-alone systems that integrate HEPA filters, fans, and control mechanisms. They are essential components of portable cleanrooms, responsible for removing harmful airborne contaminants and recirculating the air. Depending on the size of the cleanroom, multiple FFUs may be used to ensure a clean microenvironment. These units feature a pre-filter before the HEPA filter and can be installed in the ceiling, walls, or floor.
Evaluating FFUs is crucial for classifying a portable cleanroom. Their efficiency and effectiveness in maintaining a clean air environment are key factors in determining the particulate count per cubic centimeter. FFUs help maintain positive pressure to prevent the entry of non-filtered air, ensuring that only filtered air circulates within the cleanroom.
Flooring in a portable cleanroom is as critical as the walls and ceiling, as it must meet the same cleanliness standards. Portable cleanroom floors are typically raised and constructed from seamless vinyl, rubber, or perforated materials. They need to be easy to clean, non-porous, and capable of being sanitized. The type and standards for the flooring are determined by the required ISO classification of the cleanroom.
The flooring used in portable cleanrooms is often referred to as loose lay flooring, allowing for easy expansion and relocation. Loose lay flooring can be installed over existing permanent floors with minimal surface preparation. However, it must be robust enough to support the required load capacity due to the nature of cleanroom operations.
In addition to cleanliness, cleanroom flooring must adhere to safety standards to protect workers. It should be resistant to potential hazards regardless of the materials being tested. For environments dealing with semiconductors and electronics, flooring often includes static-reducing features to address the static-sensitive nature of the work.
Portable cleanroom floors commonly include anti-fatigue and autoclavable mats to enhance worker protection. A specialty mat known as a washable sticky mat is designed to remove contaminants from footwear and wheels. Entrance mats made from various materials are also used to maintain cleanliness and safety in all types of cleanrooms.
Portable cleanrooms are designed to be fully wired, eliminating the need for an electrician during assembly. Once all the components are assembled, the electrical system is configured to simply plug into the existing power supply at the installation site.
Typically, portable cleanrooms use 120/208V three-phase electrical systems to support HVAC and air handling systems. For added safety and reliability, a generator can be included to provide backup power in case of a disruption. Additionally, an uninterruptible power supply (UPS) can be installed to ensure the cleanroom remains operational without any delays.
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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