This article contains concise information regarding portable cleanrooms and their use.
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A portable or modular cleanroom is a small, preconstructed (or prefabricated) standalone system that needs electrical power and cooling. They can be delivered in 4-8 weeks depending on the style and are quick to install. In addition, portable cleanrooms can typically be assembled in 1-3 weeks.
The installation of portable cleanrooms takes less time because they are prefabricated. There is little disruption to normal operations and little to no contamination since the process goes so quickly. In addition, factory designed and fabricated portable cleanrooms reduce or eliminate the need for architects, engineers, and G/Cs, saving time and money.
Some portable cleanrooms come with wheels or casters for easy mobility, while others are shipped in sections on pallets. When they are disassembled, moved and reassembled, 90-95% of their components or materials can be reused. Portable/modular cleanrooms are cost-effective solutions, with some styles, such as modular hardwall systems, able to qualify for accelerated depreciation.
Portable/modular cleanrooms are designed to meet ISO levels 8 to 5 or Federal STD Class levels 100 to 100,000. Designed to operate as standalone cleanrooms, portable/modular cleanrooms can be used to create clean zones and hygienic work areas within an existing cleanroom making them ideal for R&D and product development. They require little space, provide mobility, are cost effective, and offer exceptionally clean and filtered airflow to create a workable, uncontaminated, and sanitized environment.
The function of portable/modular cleanrooms is to control airborne particles, such as dust, microbes, aerosol particles, and various forms of chemical vapors, to meet required limits and standards. No matter the design or style, HEPA filters are the heart of every cleanroom. HEPA filters measure cleanroom particles in micrometers or microns (µ), or one millionth of a meter. They are capable of trapping 99.97% of particles that are 0.3 micron (µ) or larger, with 1 micron being approximately 1/25 or 0.04 of an inch and 1/3 of a micron equal to 1/75 or 0.001 of an inch. The use of HEPA filters guarantees that cleanroom air will be cleaned of contaminates or microbes.
In cases where there are demanding requirements for a Lower ISO or Federal STD Class levels, such as ISO3 or Cl 10, ultra-low particulate air (ULPA) filters can be used to remove 99.9995% of particulates down to 0.12 µm. Visually, a ULPA looks identical to a HEPA filter, with the only difference being the type of filter media. Other than that, ULPA filters perform the same function as HEPA filters.
The controlled environment of a cleanroom is an essential component for the development, testing, and research of various types of technical equipment, medicines, chemicals, and substances that may be sensitive to contaminants and other forms of particulate matter. Due to the critical nature of the work of a cleanroom, their construction requires a great deal of care down to the most minute detail.
Portable/modular cleanrooms have become very popular due to their cost, convenience, quick delivery and installation, available sizes, ability to be enlarged and reconfigured, and due to the fact that most designs use an open plenum for their Classification that can be easily changed as the need arises. Additionally, portable/modular cleanrooms can be constructed to meet special needs, such as ESD or static dissipative surfaces, chemical and corrosive resistant materials, and UV filters and 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 calls out a 1 minute sample of a volume of 1 cubic meter of air. The old Fed Standard 209E required a 1 cubic foot sample measured in a minute. Currently, the standards allow for some ISO/Fed STD Class levels to be taken in a 1 minute, with a 1 cubic foot particle count mathematically converted to 1 cubic ft. into a cubic meter by multiplying the counts in a cubic ft. x 35.315 to get a cubic meter. The two sets of standards vary by the value they put on particle sizes. Businesses and companies purchasing cleanrooms are aware of their cleanroom performance standards and requirements that are set by their customers and government agencies.
Federal Standard 209E, which is old and outdated, and the International Standards Organization (ISO) are used to classify cleanrooms. ISO ratings are supposed to have replaced Federal Standard 209E but, because of the ease in converting the numbers, many companies still reference Federal Standard 209E along with the ISO Levels.
The difference between the systems is their numbering, where Federal Standards 209E classifies cleanrooms from 1 to 100,000, while the ISO classifies cleanrooms from ISO 3 to ISO 8. In both instances, the lower number is indicative of the cleanest environment. The chart below offers a comparison of the allowable particles by size and count for each system. Classifications for Federal Standard 209E are listed on the right. The classifications for the ISO are listed on the left. As can be seen by the chart, the particulate standards are basically the same, but the numbering system is different.
| ISO and Federal Standard 209E Classifications | ||||||
|---|---|---|---|---|---|---|
| Class | Max. Particles/ft3 | ISO Equivalent | ||||
| ≥0.1μm | ≥0.2μm | ≥0.3μm | ≥0.5μm | ≥5μm | ||
| 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 are based on the use of the cleanroom. Therefore, temperature and humidity control are unnecessary and can be limited to special applications where ambient air is acceptable. For example, suppose the comfort of personnel or the process being performed requires the room to be controlled at a different temperature or humidity level. In that case, the most efficient and economic control is recirculating the air. The recirculating process involves moving the largest amount of air back to the filters while a smaller amount is ducted back to the HVAC unit, which mixes with an even smaller 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.
Each of the varieties of portable cleanrooms have different types of panel designs, which can be soft or hard depending on the needs of the application and the materials to be tested or researched. A further variation is the materials used to construct the panels.
Softwall panels are used in a variety of ways such as internal dividers and flexible panels for exiting and entering the cleanroom. They serve as an excellent barrier against the outside environment since they provide a small opening. Softwall panels are also used to create a fully portable cleanroom with ISO classifications of 7 or 8.
Rigid clear panel portable cleanrooms have the durability of hard wall cleanrooms and the affordability of soft wall cleanrooms. They have the same flexibility as soft wall cleanrooms and can be easily repositioned when needed. They have ISO classifications of ISO 5 through ISO 8 and are made of acrylic or antistatic PVC.
The clear wall design makes observing cleanroom activities easy since the clear PVC panels are similar to glass. The rigid wall panels allow the cleanroom to operate at a higher internal pressure, which is adjusted by variable wall dampers that regulate airflow out of the room.
A critical aspect of constructing a portable cleanroom is to ensure that sanitation is maintained at each step of the process. The framework is a key part since it has to be flexible enough to be moved and reassembled but sturdy enough to hold the panels and provide a tight and secure seal.
Portable cleanrooms are constructed with a rigid frame of steel or aluminum that has sufficient strength and rigidity. The framework for portable cleanrooms has knocked together corners making it possible to replace individual panels without replacing the 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 determination of the type of light fixtures for a portable cleanroom are dependent on the desired ISO classification, the size of the room, and the design of the ceiling. Of all of the elements of a portable cleanroom, lighting is the least expensive since it consumes less than 1% of a cleanroom’s energy cost. The lighting has to match the needs of the room’s instrumentation and function and must be designed to fit those specific needs. Illuminance can vary between 300 lux to 1200 lux depending on the room’s requirements.
Portable cleanrooms normally have white walls that reflect light, which enhances the lighting quality. Ceilings, floors, and walls are all white and reflect light. Incandescent, high density discharge, and fluorescent lamps are the most common. Fluorescent lamps have high energy efficiency, low maintenance, and an exceptionally long life, which makes them ideal.
Included in the lighting is high ultraviolet light to reduce bacteria and contaminants. A popular addition to cleanroom lighting has been light emitting diode (LED) lights due to their long life, efficacy, and environmental compliance.
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.
For portable cleanrooms, the filtration system is installed in the ceiling as part of the air handling system. Regardless of the efficiency and extreme standards for HEPA filters, they need to be tested regularly to assess their integrity and performance. The assessment includes an evaluation of the filter for leaks or other factors that can damage the cleanliness of a portable cleanroom.
Filter fan units are stand-alone units with HEPA filters, fans, and control systems. They are a critical part of portable cleanrooms that remove harmful airborne contaminants and recirculate the air. Depending on the size of a portable cleanroom, several FFUs may be installed to ensure a clean microenvironment. They have a pre-filter before the HEPA filter system and can be installed in the ceiling, walls, or floor.
An evaluation of the FFU plays a part in classifying a portable cleanroom. Its efficiency and ability to maintain a clean air environment determine the particulate count per cubic centimeter. FFUs assist in maintaining positive pressure to prevent the reflux of non-filtered air. They guarantee that only filter air enters a portable cleanroom.
Flooring is as essential as the walls and ceiling since it has to meet the same cleanliness standards. Floors for portable cleanrooms are raised and are made of seamless vinyl, rubber, or perforated materials. The flooring has to be easily cleaned, non-porous, and sanitized. The type and standards for the flooring are determined by the ISO classification required for a portable cleanroom.
The type of flooring used for portable cleanrooms is called loose lay flooring since it can be easily expanded and moved. Loose lay flooring can be installed over permanent flooring with little preparation of the surface. However, due to the nature of the work of portable cleanrooms, loose lay flooring has to be substantial enough to endure the required load capacity.
Aside from the necessity of cleanliness, portable cleanroom flooring has to meet safety standards to protect workers. Flooring must be resistant to all possible dangers regardless of the types of materials that are being tested. In the case of semiconductors and electronics, static reduction is required due to the nature of the static-sensitive environment.
Most portable cleanroom floors supplement the protection of employees by using anti-fatigue and autoclavable mats. A specialty type of mat that is designed to remove contaminants from footwear and wheels is a washable sticky mat. As with all forms of cleanrooms, portable cleanrooms have entrance mats made of various materials.
Portable cleanrooms are fully wired in such a way that an electrician is not required during assembly. Once all the components have been assembled, the electrical system is designed in such a way that it simply needs to be plugged into the power supply of the location.
Electrical systems for portable cleanrooms are normally 120/208 3 phase higher voltage systems for the HVAC and air handling systems. As a safety measure and for backup, a generator can be added to the system to provide power in case of a disturbance of the power supply. An uninterruptible power supply (UPS) can also be used if the portable cleanroom needs to operate without any type of delay.
The main distinction between portable cleanrooms is the types of walls they have with rigid solid walls in one category and soft plastic walls in another. A further method for categorizing cleanrooms is their function, ranging from cleanrooms for patient diagnosis to ones for testing and researching chemicals and medicine.
Additionally, portable cleanrooms can be divided by their size, portability, indoor or outdoor use, and their ISO or Federal Standard 209E classifications. As with all cleanrooms, portable ones are specially designed to precisely fit the needs and requirements of an application.
Soft wall cleanrooms are a flexible, mobile, efficient, and cost effective method for creating a controlled clean air environment quickly and easily. They are designed to be able to transform any space, regardless of location, into a high performance cleanroom. Though they are referred to as soft wall cleanrooms, soft wall cleanrooms are just as robust, durable, and resilient as traditional cleanrooms.
The varying frames of soft wall cleanrooms are available in lightweight aluminum, stainless steel, or heavier steel. The frame is treated with a powder baked on coating that prevents corrosion and contamination from the ambient environment.
As with all cleanrooms, portable soft wall cleanrooms come with HEPA fan filtration units that guarantee that the portable cleanroom meets the stringent standards of ISO 4 to ISO 8 classifications. Many soft wall cleanrooms come with the popular LED lighting panels that save money and provide long lasting efficient performance.
Rigid wall portable cleanrooms have the same flexibility and quality performance as soft wall cleanrooms. The main difference is the strength, durability, and texture of the wall system, which is made from various forms of sturdy materials, including clear plastics.
Less permanent rigid wall portable cleanrooms are an alternative to solid hard wall cleanrooms and a step up from soft wall cleanrooms. Though the panels of rigid portable cleanrooms are non-porous, firm, strong, and resilient, they can be easily disassembled and reassembled economically and efficiently. Users can adjust the size of the cleanroom depending on their needs and changes in the demands of their business.
Since rigid wall portable cleanrooms are not permanent structures, they can be depreciated as an expense over seven years unlike permanent built in cleanrooms that depreciate over 39 years. Rigid wall portable cleanrooms have ISO classifications of ISO 4 up to ISO 8 but are a lower cost solution for meeting those classifications.
As with all cleanrooms, rigid wall portable cleanrooms come with an airflow fan filter unit equipped with a HEPA filtration system that guarantees their cleanliness for meeting ISO standards. The wall panels are finished with white baked enamel to seal them and prevent contamination.
Bio-clean cleanrooms are semi-rigid cleanrooms developed to meet the needs of the medical industry regarding microbial contaminants and the particulate requirements of the electronics, aerospace, and high-tech markets. As with all forms of modular and portable cleanrooms, bio-clean cleanrooms are easily expandable to meet the changing demands and requirements of the medical and technical industries.
The prefabricated design makes it possible for quick, efficient, and easy installation without substantial changes to the existing location. As with all forms of portable and modular cleanrooms, bio-clean cleanrooms are customizable to meet the special circumstances of a customer’s needs and business.
A unique form of portable and flexible cleanroom that has grown out of the COVID-19 pandemic has been the isolation medical exam pod, which allows for the testing and examination of workers and patients to prevent exposure of others to possible hazardous and unsafe conditions. They have seamless flooring for proper house cleaning and surface disinfection.
Much like larger cleanrooms, isolation medical exam pods have HVAC systems with HEPA filters and overhead lighting for sufficient elimination. The size and compactness of the pods make them easy to install. They have self-contained electrical systems and condenser units.
Isolation medical exam pods are sometimes referred to as alternative care facilities for infection control. Though their main use has been in response to the COVID pandemic, they are also being used in industrial operations for employees that get sick or injured on the job.
The post and panel design of a portable cleanroom offers several attractive features that make it one of the more popular forms of cleanrooms. The design of post and panel cleanrooms makes it possible to easily reconfigure, adjust, and expand the cleanroom to meet a company's changing needs.
Post and panel cleanrooms have four-foot panels and stud posts that dismantle into two pieces. The stud post design makes it possible to remove and replace a panel without disturbing the other panels. All the various components of a post and panel cleanroom can be reused or stored. Raceways are built into the system to allow easy access to utilities without damaging the classification of the cleanroom.
The panels for a post and panel portable cleanroom are made of vinyl, melamine, laminate, reinforced fiberglass, stainless steel, aluminum, or steel with cores of polystyrene, polyisocyanurate, fiberglass, and honeycombed aluminum. As with all portable cleanrooms, post and panel ones can be placed outside a building or inside depending on the needs, use, and requirements of the customer.
Gradually, over the last few years, cleanroom users have been moving away from building permanent cleanrooms and are relying more heavily on portable, adjustable, and adaptable cleanrooms that can be configured and shaped to meet the demands of business. Part of the reason for this shift in focus is due to the efficiency of portable cleanrooms as well as their much lower cost.
Additionally, with the rise of technology, more and more industrial companies are finding the need for environments that are exceptionally clean and uncontaminated for a variety of assembly and manufacturing processes. This has further expanded the market for portable cleanrooms and has led to the rise of cleanroom rental organizations that can meet the needs for temporary installations.
One of the conveniences of portable cleanrooms is their ability to quickly adjust to the demands and requirements of a process, operation, or application. Though many industries that necessitate sanitized conditions already have permanent structural facilities to meet their production needs, in certain cases, they require rapid adjustments to their infrastructure to meet the stipulations of increased demands. Those are situations where portable cleanrooms prove to be an ideal solution.
Permanent cleanrooms have always been a necessary part of producing and manufacturing medicines, ointments, and medical instruments. The hygienically uncontaminated conditions are required by the Food and Drug Administration (FDA) as protection for customers of pharmaceutical products.
In situations where there is a need for extra room or the isolation of a research procedure, portable cleanrooms are a quick, easy, and flexible solution that can be erected and put to use in a short time. They have become an essential part of the efforts to produce and distribute the COVID vaccine.
The use of ultra-clean environments has become a necessity for the high tech industries due to the delicate and sensitive nature of their products. The production needs and demands for technical products can quickly shift requiring immediate adjustments to production facilities. Portable cleanrooms are an ideal solution and fit conveniently into the organization of technical processes providing the perfect ISO qualified environment.
Normal manufacturing and industrial operations, for many years, have not found it necessary to have spotless and uncontaminated environments. Their operations have depended on heavy machinery and complex assembly processes performed by innovative technical devices.
As the computer age has affected society, it has impacted industrial organizations that have found that they need to install and use cleanrooms for various processes that demand uncontaminated conditions. Since those conditions are not a regular occurence, manufacturers use portable cleanrooms to fill the cap and meet the needs of a design or process.
As with any type of product that is consumed by the public, the food industry is very closely watched by the FDA to ensure food products are produced in hygienically sanitized conditions. For this reason, food producers have permanent cleanrooms to meet the needs of normal production.
When there is a spike in demand and a rise in consumption, food producers need a convenient and quick method for expanding their operations to meet radical shifts and changes. To meet the need, they rely on portable cleanrooms and their flexibility.
Cultivation requires cleanrooms that can be quickly set up and adjusted but have the requirements necessary to protect products during their growth cycle. Portable cleanrooms meet all of the necessary standards and have the required flexibility and secure seal. Unlike the needs of other industries, the cultivation industry necessitates cleanrooms that are capable of load bearing to handle the weight of the racks of products. For this reason, portable cleanrooms for the industry have substantial strength to handle the loads.
The rapid growth of the portable cleanroom industry has necessitated the examination of their benefits and methods for keeping them safe such that they can offer exceptional performance. Portable cleanrooms have become an important tool being used by several industries to meet the needs for an uncontaminated environment using an adaptable solution.
Care and safety for the protection of workers is a necessity in work conditions. This is especially true in regard to cleanroom use. By applying simple practices, a portable cleanroom can be a valuable tool that will last and provide excellent performance.
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:
The safe operation and control of a portable cleanroom is essential for protecting employees, products, processes, and applications. Prior to or during the installation of a portable cleanroom, necessary safety protocols and procedures should be instituted. Staff should be thoroughly trained and informed regarding the steps necessary for their protection and that of products and processes.
Safety procedures include:
These particular safety procedures are generic and should be adjusted to fit the needs of a company's conditions and environment since each portable cleanroom installation is unique and customized.
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