This Article takes an In-depth look at the Types of Cleanrooms
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A cleanroom is a specially engineered environment constructed to remove dust particles and atmospheric pollutants. These rooms are critical in scientific research, pharmaceutical manufacturing, and other sectors where product integrity can be compromised by unclean conditions.
The categorization of cleanrooms is determined by the concentration of particulate matter (PM) in the atmosphere, which encompasses particles and liquids per cubic meter. Normally, the air we breathe has approximately 35 million particles per cubic meter, with each particle approximately 0.5 micrometers (ÎĽm) in size.
The International Organization for Standardization (ISO) uses a system to classify cleanrooms, grading them from ISO 1, which denotes the utmost level of cleanliness, to ISO 9, conveying a less rigorous level of cleanliness. This system is based on particle size and concentration within the cleanroom's atmosphere.
Historically, the United States applied the Federal Standard 209E for cleanroom categories, published by the Institute of Environmental Sciences and Technology (IEST) in 1963. This system categorized cleanrooms from Class 1, similar to ISO 3, to Class 100,000, comparable to ISO 8. Though some countries still apply the IEST system, it was officially phased out in 2001 due to its outdated status.
For decades, professionals faced challenges in creating clean environments due to uncontrollable airflow and particles. In 1960, physicist Willis Whitfield introduced an innovative filtration system, setting the foundation for the contemporary cleanroom.
Cleanrooms are integral to specialized sectors such as pharmaceuticals, biotech, semiconductors, laboratories, microchip manufacturing, and photovoltaics. Manufacturing processes requiring precise control over production and handling need cleanrooms. The required cleanroom standard is dictated by the product's nature and sensitivity.
Key to cleanroom requirements is protecting personnel. Staff must wear specially designed protective gear to prevent contamination. Made from sturdy synthetic materials, these are typically for single-use. Additionally, all items entering the cleanroom must undergo stringent classification and approval, ensuring all aspects are meticulously managed.
Traditional furniture is absent in cleanrooms. Surfaces are devoid of bolts, nuts, or visible joints to prevent dust accumulation. Equipment is smooth, polished, and crafted from materials such as plastic or high-grade stainless steel. Cleanroom design is minimalistic to reduce contamination risks significantly.
Lighting in cleanrooms ensures adequate visibility while meeting strict hygiene regulations. These lighting systems are built for longevity and low maintenance, as frequent cleaning can require cleanroom recertification.
Airflow is the most vital aspect of cleanrooms. Precision in air movement typically involves unidirectional flow, where air descends through the ceiling and exits through the floor. Negative pressure is maintained to prevent contaminant escape and external pollution entry. The airflow system's design and type are determined by the materials managed within the cleanroom.
Cleanrooms entail substantial construction and operational expenses, averaging $100 to $150 per square foot. A 10x10-foot cleanroom, roughly the size of a modest bedroom, costs between $10,000 to $15,000, subject to the air control system and instrumentation configurations.
An adaptable alternative is the modular cleanroom, known for easy construction and reconfiguration. These cleanrooms provide the same contamination-free environment as more costly models, at a reduced expense. Modular cleanrooms are an optimal choice due to their flexibility and efficient contamination oversight.
During the COVID-19 pandemic in 2020, cleanrooms proved to be an essential component in medical treatment, scientific research, and pharmaceutical development. Since their invention in the 1960s, cleanrooms, also referred to as controlled environments, have been utilized across a wide range of industries—including electronics, aerospace, biotechnology, and nanotechnology—providing critically controlled conditions for manufacturing and research processes that demand the strictest contamination control. Below, you'll find an in-depth description of several applications of cleanrooms, supporting diverse sectors and reinforcing the importance of cleanroom technology and standards.
Hospital isolation rooms are a specialized type of cleanroom environment designed for stringent infection control and patient safety. These medical cleanrooms are engineered to separate patients with infectious or immunocompromising conditions from the rest of the healthcare facility. As with traditional cleanrooms, isolation rooms may be ISO-classified (such as ISO 7 or ISO 8) based on their intended function and the required level of sterility. Typical uses involve containing patients with confirmed airborne or contact infections or safeguarding patients whose weakened immune systems render them more susceptible to hospital-acquired infections (HAIs).
The air pressure in an isolation room is adjusted depending on patient needs and contamination risk. Negative air pressure isolators are used for patients with contagious diseases to ensure pathogens cannot escape into surrounding spaces, with all air drawn in, filtered through HEPA filters, and then safely exhausted. For bone marrow transplant patients or those at risk for opportunistic infections, positive air pressure isolation is utilized, preventing airborne contaminants from entering. High-efficiency particulate air (HEPA) filters are critical to both designs, efficiently removing dust, pollen, mold, bacteria, and particles as small as 0.3 µm.
Modern hospital cleanrooms are a collaborative achievement between clinical staff and clean room designers, integrating advanced environmental monitoring, pressure alarms, hands-free sanitation facilities, and no recirculating air to maintain a sterile environment. These features ensure hospitals meet evolving CDC, USP, and WHO infection control guidelines for critical care spaces.
Cleanrooms are fundamental to the success of the semiconductor, nanofabrication, and microelectronics industries. The sensitive and delicate nature of electronics manufacturers' equipment requires extremely stringent environmental controls, as even a single contaminant particle or change in electrostatic discharge (ESD) can cause product defects and lower manufacturing yields. Semiconductor cleanrooms are engineered for strict particulate, temperature, and humidity control, with advanced UV filtered lighting and built-in electrostatic discharge filtration systems.
Within semiconductor and microelectronic facility design, control of ultrafine contamination is paramount. Just one microscopic particle can lead to chip defects, impacting processes like photolithography, etching, or wafer bonding. Cleanroom design specialists address every detail: non-shedding wall materials and flooring, antistatic workstations, optimized airflow systems, redundant power supply, integrated data logging, and dust-free storage. The ISO 14644 classification for these cleanrooms is typically ISO 3, ISO 4, or ISO 5, with corresponding air change rates and filtration protocols to minimize downtime and support continuous manufacturing.
Processes within these facilities rely on support zones, such as gowning rooms, anterooms, airlocks, and pass-throughs, to maintain the required cleanroom standard. Cleanroom protocols specify the use of cleanroom garments and accessories, with routine environmental monitoring and regular certification by third-party inspectors. Microelectronics and semiconductor manufacturers regularly update their cleanroom requirements to comply with evolving industry standards and to leverage next-generation contamination control technologies, such as cleanroom robotics and modular cleanroom construction.
Each cleanroom is custom-designed based on the manufacturing requirements and product specifications, reflecting ongoing innovation in cleanroom architecture and contamination control engineering, crucial for industries seeking to ensure the highest quality microchips, sensors, and electronic assemblies.
Medical devices are assembled and manufactured in GMP (Good Manufacturing Practice) cleanroom environments to ensure their safety, quality, and compliance with regulatory requirements. Since these devices are placed in direct contact with patients, cleanroom manufacturing for medical devices involves stringent environmental controls, precision cleaning, and real-time monitoring of airborne particles and microbial contaminants. Cleanrooms play a critical role in processes such as injection molding, micro-assembly, packaging, sterilization, and final inspection of medical devices and surgical implants.
Unlike general industrial cleanrooms, cleanrooms for medical device production are subject to regular FDA inspections and must adhere to ISO 13485:2016 quality standards. These facilities are classified based on ISO 14644 classifications, often ISO 7 (Class 10,000) or ISO 8 (Class 100,000), but may require ISO 5 or lower for aseptically manufactured devices such as implantables or catheters. Cleanroom design factors include facility layout, gowning procedures, HEPA filtration systems, worker attire, and rigorous bioburden monitoring. Over time, the global regulatory landscape has led to increased harmonization of standards, with compliance to international agencies like WHO and regional authorities (e.g., EU MDR).
Advancements in contaminant control, coupled with automation and real-time environmental monitoring, have significantly improved the reliability of finished medical devices. Companies must adapt their cleanroom operations as new technologies emerge, ensuring all aspects of device manufacture—especially those affecting Class III devices—meet and exceed regulatory requirements for cleanliness, sterility, and product traceability.
Pharmaceutical cleanrooms provide an environment that strictly prevents microbial and particulate contamination, as required by FDA cGMP (Current Good Manufacturing Practice) and USP General Chapter for sterile compounding. These pharmaceutical cleanrooms are engineered to control temperature, humidity, air pressure, and air exchanges while offering HEPA-filtered air and robust monitoring of particles and environmental parameters.
Compounding pharmacies, responsible for mixing customized medications tailored to unique patient needs, rely on cleanroom facilities classified as ISO 7 or ISO 8 environments. Compounded sterile preparations (CSPs), like intravenous drugs or ophthalmic solutions, are particularly sensitive to environmental contamination. Cleanroom criteria for these settings include segregated containment (for hazardous drug compounding; USP compliance), restricted-access barrier systems (RABS), and continuous surface, air, and personnel monitoring. Adhering to regulatory guidelines and environmental control standards is essential to assuring safe and effective pharmaceuticals while protecting public health.
The demand for USP 797 and USP 800-compliant cleanrooms has accelerated as pharmacy compounding has grown. Businesses invest in validated cleanroom design, HVAC strategies, high-grade filtration, hands-free operations, and pass-through equipment to minimize contamination. Modern compounding cleanrooms leverage modular construction for quick certification and flexibility as compounding volumes change.
The "ballroom" cleanroom concept offers maximum flexibility, accommodating multiple equipment lines or production shifts within a single large open area. Unlike mini-environments or modular isolators that enclose specific tools, ballrooms allow reconfiguration for varying process requirements, pilot projects, or scale-up production in sectors such as electronics, aerospace, pharmaceuticals, and advanced materials manufacturing.
To maintain compliance with ISO cleanroom standards (usually ISO 6 or 7), ballroom cleanrooms are equipped with robust air management systems, mobile equipment on anti-static wheels, pressure monitoring, and comprehensive cleaning protocols. These expansive cleanrooms are often used in precision manufacturing, biotechnology pilot plants, and aerospace assembly to support simultaneous processes while minimizing cross-contamination risks through strategic zoning, air curtain barriers, and clear operational separation.
The main challenge in ballroom cleanroom design is ensuring the entire large area—often several thousand square feet—meets ISO or Federal Standard 209 classifications for particle count, airflow patterns, and personnel behaviors. Integrated monitoring systems and well-established standard operating procedures (SOPs) are crucial to maintaining consistent contamination control and regulatory compliance across the entire workspace.
The most crucial component of a cleanroom is its air filtration system, which starts with HEPA filters designed to capture particles as small as 0.3 ÎĽm. To qualify as a HEPA filter, it must remove 99.99% of contaminants, including microorganisms, dust, and other airborne particulates. Cleanrooms typically use multi-stage filtration, beginning with pre-filters for larger particles, then routing airflow through strategically placed HEPA or, in some cases, ULPA (ultra-low penetration air) filters for enhanced particle removal in critical zones. Filters are commonly tested and validated per international standards such as ISO 29463 or EN 1822 to ensure reliability in cleanroom applications for pharmaceuticals, microelectronics, and biotechnology.
Most cleanrooms, whether softwall or hardwall, are designed with ceiling-mounted filters to enable laminar (unidirectional) downward airflow, reducing cross contamination and surface deposition of particles. This configuration supports both single-pass and recirculating air handling systems. A key factor in determining a cleanroom's classification is its air change rate (ACR), which can reach up to 300 air changes per hour depending on the cleanroom ISO class and process sensitivity.
Cleanroom ceilings are a critical architectural element, providing a sealed structural barrier that helps maintain pressure differentials and prevent particulates from entering the controlled space. These typically feature drop or suspended ceilings made from acoustical panels mounted on precision-fitted grid systems, manufactured exclusively from non-shedding, cleanroom-compliant materials such as powder-coated aluminum or stainless steel. The tight fit of each component and seamless panel connections are paramount to cleanliness, ensuring there are no gaps through which dust, lint, or biological contaminants could infiltrate.
Ceiling grid systems also accommodate cleanroom lighting, air filtration modules, and service panels while maintaining their structural integrity and resistance to chemical attack. When installed, tiles are sealed using a gel or rubber gasket along their edges to encapsulate the space. For applications where sterility is paramount, ceiling construction is validated to resist corrosion and frequent cleaning with disinfectants or alcohol solutions.
Lighting design is tailored to support critical visual inspection tasks and compliance with OSHA lux-level requirements, but must never interfere with laminar or turbulent airflow patterns or compromise the effectiveness of ceiling-integrated filtration systems. Energy-efficient LED fixtures are industry standard, often flush-mounted for easy cleaning and minimal disruption. Ideally, all service work is carried out from the top of the cleanroom to eliminate downtime and maintain environmental integrity.
Ceiling systems for cleanrooms are produced from premium raw materials, then meticulously cut, shaped, and sealed for a precise fit—ensuring tile layouts are strictly uniform and do not harbor dust or pathogens.
Cleanroom ceiling tiles are available in a wide array of sizes and material options—with common selections including vinyl-coated gypsum, mineral fiber, aluminum, and polycarbonate. These tiles are engineered to be smooth, non-porous, washable, and chemical-resistant, supporting disinfection protocols and ensuring regulatory compliance. Key attributes required include water-repellency, scratch resistance, and the ability to withstand harsh cleaning agents without degrading or producing particulates (non-shedding).
Gypsum tiles, typically ½ inch thick, are finished with high-grade white vinyl to deliver a durable, stain-resistant, and easy-to-clean surface. For more demanding applications, options include fiberglass-reinforced plastic (FRP) and sealed stainless steel. Tile construction must ensure optimal light reflectance and contribute to acoustic noise suppression, enhancing productivity and worker comfort in specialized lab and manufacturing environments.
Vinyl coatings and sealed edges guarantee zero particle emission into the controlled space, a requirement for compliance with ISO 5 (Class 100) and food-grade cleanrooms (USDA/FSIS approved). Other specialized coatings, such as anti-microbial or anti-static finishes, are available for biopharmaceutical production and electronics assembly environments. Cleanroom ceiling tiles play a vital role in maintaining sterility and cleanliness across a diverse range of industrial applications, from pharmaceutical labs to food processing and advanced research facilities. Each tile is securely fixed within the cleanroom grid system, providing a reliable barrier against contaminants.
For a room to be classified as a cleanroom, it must meet rigorous international standards, most notably those established by the International Organization for Standardization (ISO 14644) or, in legacy installations, by Federal Standard 209E. ISO cleanroom standards outline maximum permissible particle counts for various classes, ranging from ISO 1 (the cleanest) to ISO 9 (least clean). Over 20,000 standards maintained by ISO guide global compliance for cleanroom design, validation, and operation, influencing chemistry labs, microchip fabs, biotech production, pharmaceutical compounding, and defense applications.
Class 100 clean rooms (ISO 5) represent one of the highest Federal Standard 209E classifications, permitting no more than 100 individual particles (�0.5 microns) per cubic foot of air. For perspective, the human eye can see particles as small as 40 microns; thus, Class 100 cleanrooms are essentially particle-free at a microscopic level. These rooms leverage advanced HEPA or ULPA filter banks, automated environmental controls, and rigorous cleaning regimes. Common wall panel materials for these strict environments include white acrylic, stainless steel, aluminum, and polycarbonate—selected for their non-shedding, easy-clean properties. Entry to Class 100 rooms requires special garment protocols and entry through airlocks or dress-out areas to prevent contamination.
Class 100 cleanrooms are crucial in the manufacture of semiconductors, pharmaceutical fill-finish operations, and key medical device verification and packaging processes, where the utmost sterility and contamination control must be maintained.
Class 1,000 (ISO 6) clean rooms permit up to 1,000 particles (�0.5 microns) per cubic foot of air—balancing stringent control with operational flexibility. Class 1,000 clean rooms are often the workhorse environments in applied research, medical device assembly, and electronics manufacturing where a balance of production throughput and particle control is needed. These spaces are optimized for specialized processes such as photolithography, laser micromachining, wafer inspection, non-contact metrology, and advanced materials research. Their versatility means they are widely used in cleanroom manufacturing, bio/pharmaceutical R&D, and in food processing for high risk or allergen-sensitive products.
Class 10,000 (ISO 7) clean rooms operate with higher permitted particle counts—up to 10,000 particles (�0.5 microns) per cubic foot. Class 10,000 cleanrooms provide controlled environments for final assembly, packaging, and less contamination-sensitive processes, such as certain medical device packaging, component storage, and environmental monitoring instrument staging. In these rooms, air changes occur 40-60 times per hour, with procedural controls over cleaning, personnel movement, and gowning to support ISO and cGMP requirements. Class 10,000 rooms are vital to food and beverage, cosmetic, and diagnostic kit manufacturing, where clean but not aseptic conditions are required.
Cleanroom equipment includes a broad range of movable, sterilizable, and non-shedding items essential to daily cleanroom operations. These can include automatic shoe cleaners, air showers, containment hoods, desiccator cabinets, pass-throughs, particle counters, laminar flow benches, HEPA/ULPA filtration modules, and environmental monitoring systems. Soft goods and consumables such as cleanroom apparel (gowns, hoods, gloves, booties), wipes, disinfectants, and packaging materials are sourced from certified cleanroom suppliers, ensuring all components meet ISO or cGMP standards.
Here is a brief list of some equipment typically found in a cleanroom:
Controlling contamination from personnel is a top priority in cleanroom maintenance, given that shoes are a significant source of particulates. Automatic shoe cleaners, also known as shoe cleaning stations, use built-in vacuums and mechanical brushes to remove debris from every surface of a shoe, often integrating HEPA filtration to capture even sub-micron particulates. Cleanroom protocol frequently requires personnel to change into dedicated footwear or use disposable shoe covers after using these devices. Thorough shoe cleaning plays an essential part in meeting ISO cleanroom standards and minimizing the risk of cross-contamination from outside environments.
Advanced shoe cleaner units can be installed on-site as standalone systems or integrated within the entrance pass-through, helping facilities meet their specific cleanroom certification and environmental control needs. Their capacity to accommodate a range of shoe types and sizes make them a reliable contamination prevention solution for pharmaceuticals, electronics, medical, and food industry cleanrooms.
A pass-through is an engineered solution that minimizes foot traffic and potential contamination by enabling the transfer of sterilized tools, documents, and supplies between cleanrooms and adjacent spaces. These units—variously designed as cabinets, chambers, or enclosed windows—are validated to match the cleanroom’s ISO class, using interlocked doors, HEPA filtration, and optional UV-C or chemical disinfection to assure cleanliness of transferred items. Gowning, hand hygiene, and proper use of pass-through protocols are essential for effective contamination control, forming part of Cleanroom Standard Operating Procedures (SOPs).
To provide an additional layer of safety and contamination control, cleanrooms deploy containment hoods—including laminar flow, chemical fume, and biological safety hoods—tailored to the nature of work being performed. Laminar flow hoods (vertical or horizontal) generate a filtered, particle-free air barrier over sensitive materials. Fume and exhaust hoods are essential for processing volatile or hazardous substances, while biological safety cabinets protect against microbial contamination. These hoods are specified based on application, ISO classification needs, and operator safety, supporting biopharmaceutical, chemical, and semiconductor processes with precise environmental isolation.
Continuous monitoring of airborne particulate levels is achieved via high-precision optical or condensation particle counters. These monitor, classify, and help diagnose contamination by measuring the size and volume of airborne particles—crucial for ongoing cleanroom certification and compliance. Data from particle counters supports ISO or GMP documentation, helping facilities adapt to events that may impact quality or safety. Regular calibration and validation of these devices are critical for accurate reporting and process control.
Desiccator cabinets offer ultra-dry or nitrogen-purged controlled storage, preventing humidity-induced degradation of materials and sensitive components. Constructed from non-shedding welded stainless steel or acrylic, these chambers are vital to semiconductor, pharmaceutical, and electronics cleanrooms for storing reagents, substrates, or finished goods. Features such as electrostatic discharge (ESD) protection and airtight gaskets ensure stored items remain safe from both moisture and static damage, maintaining the integrity of high-value products.
Personnel and material air showers are engineered vestibules equipped with high-velocity HEPA-filtered air jets that remove surface particles from garments and equipment prior to cleanroom entry. Their use is especially critical in high-class (ISO 5 or better) cleanrooms or in industries such as electronics and biotechnology where even minute contamination can cause catastrophic losses. Customizable configurations—straight-through, 90-degree, multi-door—can accommodate differing facility needs, supporting rigorous decontamination protocol compliance and efficient throughput.
Modern environmental monitoring systems provide a central platform for real-time, integrated surveillance of cleanroom parameters: temperature, humidity, differential pressure, airborne particulate concentration, and even surface microbial counts. Utilizing a network of sensors, smart alarms, and data-logging software, these systems ensure rapid detection of contamination risks and ongoing compliance with regulatory mandates (e.g., FDA, EU GMP Annex 1, ISO 14644-2). Data trends support continuous improvement and risk assessment, and automated system validation accelerates audit processes for pharmaceutical, biotechnology, and advanced manufacturing facilities.
Laminar airflow—defined as continuous, parallel, and unidirectional air movement—is the preferred ventilation standard in most cleanrooms, as it effectively prevents particle recirculation and ensures contaminants are consistently moved away from critical workspaces. Air is first drawn through a pre-filtration stage, followed by advanced HEPA or ULPA filters, to achieve the ultra-pure air required by the cleanroom ISO class. This clean air is delivered via ceiling, wall, or floor inlets, flowing at a constant velocity, and is exhausted through floor grilles or low wall returns. The result is a stable, controlled environment by minimizing turbulence, cross currents, and the resuspension of contaminants.
The effectiveness of laminar flow is underpinned by high-grade ducting—constructed from stainless steel or non-shedding metal—and the careful positioning of filters and exhaust. Laminar (unidirectional) and turbulent (non-unidirectional) airflow patterns are selected based on the contamination risk and the cleanroom’s process requirements. Properly designed airflow systems are validated with smoke studies and airflow visualization to guarantee full coverage and adherence to ISO or GMP cleanroom validation protocols. Maintaining this standard is vital for pharmaceutical aseptic processing, microelectronics fabrication, and any application where even trace levels of contamination can compromise product safety or efficacy.
Cleanrooms are designed to maintain a consistent airflow in a confined space with uniform velocity to avoid turbulence. This is achieved by a ducting and fan system that is connected to a filter, which is usually a high efficiency particulate air (HEPA) filter.
When constructing a cleanroom, it is crucial to address potential electrostatic discharge (ESD), as it can damage or contaminate materials. To mitigate ESD risks, floors and surfaces are designed to prevent static buildup by creating a controlled, non-static environment. This helps ensure that materials and equipment remain protected from electrostatic interference.
As a part of the concern for airflow is the construction of the ventilation and air volume systems that are designed to maintain air quality and pressurization. The ventilation system is constantly exchanging old air with fresh filtered air.
Cleanrooms are typically maintained at a static pressure higher than atmospheric pressure to prevent the ingress of outside air and contaminants. However, in cases where a cleanroom is used for handling hazardous materials, it must be maintained at a negative pressure. This negative pressure ensures that any potentially harmful substances remain contained within the cleanroom and do not escape, thereby protecting both personnel and the surrounding environment.
In a cleanroom, maintaining constant temperature and humidity is crucial for ensuring stable conditions for materials and instruments. High humidity can cause corrosion or condensation, potentially damaging products and equipment. Therefore, humidity levels must be carefully monitored and controlled. Proper humidity control also helps in reducing static electricity, further protecting sensitive components and processes.
Modular cleanrooms are a cost effective solution for small companies or ones seeking a quick method for installing a cleanroom. They come in two varieties � hard or soft walled. Hard walled modular cleanrooms have a rigid construction with walls mounted between posts to increase volume for internal air pressure to help minimize contaminants. Soft walled modular cleanrooms have curtains made of vinyl and can have up to a 24 feet span between columns. They are simple to install and cost effective.
All cleanrooms must meet ISO standards. Permanently constructed cleanrooms can meet the cleanest standards of an ISO classification of 1. Modular models, soft or hard walled, meet ISO standards of 5 to 8 depending on construction.
Portable clean rooms, akin to soft wall modular units, are versatile enclosures designed for atmospheric and climate control, ideal for research and fabrication. These units are easily assembled and disassembled on-site without the need for additional assistance. The rising demand for adaptable and mobile cleanroom solutions has significantly boosted their popularity.
Portable clean rooms are movable atmospheric and climate-controlled enclosures used to conduct research, fabrication, and other sensitive operations. They are often modular, and some models can be assembled and disassembled without the assistance of service companies. Portable clean rooms are useful for operations that require a basic measure of control over the environments in which their operations are conducted.
Stick-built clean rooms offer an alternative to modular clean rooms. Constructed with a metal framework, known as "sticks," and covered with gypsum wallboard, these clean rooms provide a cost-effective and straightforward solution. Their adaptability allows them to be tailored to fit any workspace. Building a stick-built clean room involves creating a custom floor plan, installing walls and ceilings, setting up a high-efficiency HVAC system, and integrating other components to meet specific clean room requirements.
Stick-built clean rooms can feature various ceiling types, including grid systems or hard ceilings made of gypsum wallboard. Both the walls and ceiling are typically coated with epoxy or PVC for added protection. The versatility of stick-built clean rooms is a key factor in their popularity; they can be easily adapted to fit new or changing spaces as a business expands or redesigns its facilities.
Like all clean room types, stick-built clean rooms have their drawbacks. One significant issue is their durability. While they are less expensive to construct, this lower cost is offset by a shorter useful life. Additionally, stick-built clean rooms require regular maintenance and upkeep, which can further negate their initial cost advantage.
A standard clean room is designed to shield products or processes from particulate contamination that could compromise quality. The specific type of clean room is determined by its ISO classification, which outlines the cleanliness standards required. Standard clean rooms are commonly used in industries such as semiconductor manufacturing, pharmaceuticals, biotechnology, and medical device production, where maintaining a controlled environment is critical for ensuring product integrity and operational success.
When discussing a standard clean room, it's important to recognize that clean rooms are tailored to meet the specific conditions of their intended use. Each type of clean room is designed to address particular criteria, so there are distinct clean rooms for microelectronics, pharmaceuticals, and other industries. Factors such as the type of product, regulatory requirements, and available space all influence the design and suitability of a clean room for a given process or operation.
A clean room is essentially a controlled environment designed to minimize and control particulate contamination in the air. To achieve this, the room is carefully configured to reduce the size and number of airborne particles. It also includes systems to regulate temperature, humidity, and pressure. A crucial component of a clean room is its use of HEPA filters, which ensure that all incoming air passes through a series of filters to maintain a specific level of cleanliness.
A clean room's definition also extends to the protocols for personnel who operate within it, including stringent dress code requirements. As the ISO rating of a clean room becomes stricter, the measures to prevent contamination by personnel become more rigorous. These requirements dictate the type of attire allowed in the room, ranging from basic items like hair nets, masks, gloves, and lab coats to more comprehensive coverings known as bunny suits, which provide full-body protection to minimize any potential impact on air quality.
When considering or purchasing a clean room, it's crucial to remember that it is a highly controlled environment with strict requirements that must be adhered to. These standards are established to safeguard both personnel and the integrity of the products being handled. Workers in a clean room are thoroughly trained and informed about the specific conditions and requirements of their environment. They are expected to follow these guidelines diligently to maintain the clean room's effectiveness and ensure the quality and safety of the processes conducted within it.
A turbulently ventilated clean room features non-unidirectional airflow, meaning that the air within the room is mixed with filtered air to eliminate any lingering contaminants. Unlike unidirectional systems, which direct airflow in a controlled manner, turbulent airflow systems rely on complex filtration methods to remove particulate matter. These clean rooms use a combination of laminar filters and random, non-specific velocity filters. The random movement of air in these systems helps to disperse particles throughout the room, allowing them to be captured by the intricate filter system. The pattern of turbulent airflow makes it challenging to separate particle-laden air from cleaner air, but the filtration system is designed to address this by processing all air through multiple stages of filtration.
In a turbulently ventilated clean room, air moves in multiple directions throughout the space, and air quality is managed by directing and circulating the air towards strategically placed filters, which may be located in one central area or distributed throughout the room. Despite the seemingly chaotic nature of turbulent airflow, the system is carefully planned to navigate around tools, booths, objects, and equipment, creating a complex network of air paths. This constant movement ensures that the air is continuously filtered, helping to maintain cleanliness by passing it through the filters repeatedly.
In a turbulently ventilated clean room, the airflow creates a vortex-like pattern as incoming air mixes with the existing air in the room. This mixing action helps to dilute the concentration of particles, making it easier for HEPA filters to capture and remove them. The constant movement of air through the filters is crucial for maintaining air quality, as it ensures that particulate levels and sizes remain within acceptable limits. This dynamic airflow system helps to effectively manage contamination by continuously processing and filtering the air.
Unidirectional clean rooms are the most prevalent type, characterized by airflow that moves in a single direction, either horizontally or vertically. This design allows unidirectional clean rooms to achieve high ISO classifications, such as ISO 5 or better. In these rooms, filtered air is introduced from the top and flows downward, effectively sweeping away contaminants. The contaminated air is then expelled through vents located at the bottom or sides of the room. The airflow velocity in a unidirectional clean room typically ranges from 0.3 to 0.5 meters per second, ensuring efficient air exchange and contamination control.
In a unidirectional clean room, the airflow is controlled by laminar air flow hoods, which ensure that the air moves in a consistent, unidirectional pattern. The room's design is specifically engineered to minimize turbulence, which could disrupt the intended flow of air. This configuration ensures that only clean, filtered air is introduced into the room. The unidirectional airflow effectively removes particles from personnel and equipment, maintaining a high level of cleanliness and preventing contamination.
In a unidirectional clean room, air circulates at a steady velocity along parallel streamlines, ensuring that particulate matter is not reintroduced into the space. The airflow follows a straight, unobstructed path guided by laminar flow hoods, which direct the clean air uniformly throughout the room. This method of airflow is highly efficient for contaminant removal due to its consistency and the absence of turbulence, providing an optimal environment for maintaining cleanliness.
As clean room technology continues to advance, older clean rooms may be left behind to take advantage of the newer versions. However, used clean rooms can provide much the same functionality as new clean rooms, but may not use the same newer, more advanced technology. When purchasing a used clean room, you are essentially trading the newer, more advanced features of a new clean room for reduced upfront costs.
For applications that don't need advanced control features, this trade-off is often a practical and cost-effective choice. However, it's crucial to remember that used clean rooms might lack the necessary features and could present issues related to extended use.
Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration's standards (known as FS209E) were applied virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.
The FS209E classification system includes six classes, ranging from Class 1, the cleanest, to Class 100,000, the dirtiest. In comparison, the ISO 14644-1 classification system introduces two additional cleaner standards and one dirtier standard. The "cleanest" cleanroom in the ISO system is ISO Class 1, while the "dirtiest" is ISO Class 9. ISO Class 3 is roughly equivalent to FS209E Class 1, and ISO Class 8 aligns closely with FS209E Class 100,000. The ISO system rates cleanroom cleanliness based on the concentration of particulates of specific sizes per cubic meter.
Softwall clean rooms are enclosures that are atmospheric and climate-controlled, and are used in industries that involve carrying out sensitive testing, fabrication, and research processes, such as biotechnology research, medical testing, and semiconductor fabrication. Soft wall clean rooms differ from hard wall clean room systems in several ways.
Soft wall clean rooms feature walls made from either fabric stretched over a frame or translucent plastic strips suspended from a ceiling or other overhead fixture. Unlike hard wall clean rooms, which are typically permanent fixtures, soft wall clean rooms are designed for greater portability. They can be easily moved and reconfigured. Many soft wall clean rooms are available in modular designs, allowing for faster and simpler disassembly and reassembly.
Everything that enters a cleanroom must comply with the room's ISO standards, including items like bottles, gloves, wipes, bags, and swabs. Even seemingly mundane items, such as documents and reference manuals, must meet these stringent requirements before they are allowed into the cleanroom environment.
There are several distributors that specialize in cleanroom supplies. All of them carry a large inventory of solutions designed for controlled environments. The term cleanroom supplies is a very broad encompassing a wide range of sterile sanitary items.
The ISO restrictions make the production, creation, and distribution of cleanroom supplies very restrictive. For a cleanroom to maintain its classification, every part of it has to be in accordance with ISO regulations, including the supplies. One bottle or plastic bag that does not meet regulations can cause the room to be declassified and require reclassification.
Designing a cleanroom is a specialized process that involves numerous considerations to ensure it meets the specific needs of the user. Each cleanroom is tailored to the unique requirements of the company it serves. The most fundamental consideration is the budget, which can be complex and challenging to determine based on the level of cleanliness required.
Cleanrooms are classified based on the cleanliness and particulate count of the air within them. This classification is determined by the quantity and size of particulates present. ISO 14644-1 provides guidelines for air cleanliness classification, specifying the required limits for airborne particulate counts. To ensure they maintain their designated classification, cleanrooms are routinely tested and monitored.
In recent years, ISO 14644-1 has been revised multiple times to simplify and streamline the classification process. These updates reflect ongoing advancements in production technology and aim to make the classification system more relevant to current conditions. The revisions help ensure that the standards remain applicable and effective in accommodating the latest developments in cleanroom technology and practices.
Cleanroom walls come in three primary types: soft, hard, and rigid, each varying in cost. The most economical option is soft walls, which are constructed from durable polymers like polyvinyl chloride (PVC). These walls are sturdy and flexible, offering a cost-effective solution for cleanroom environments.
Rigid walls offer a compromise between hard and soft walls. Made from various types of clear, hard plastics, they combine the sturdiness of hard walls with the ease of removal characteristic of soft walls. This makes them a versatile option that balances durability with flexibility.
Insulated hard walls offer the highest level of protection for cleanroom operations, providing a secure and impenetrable surface that meets the requirements for any classification level. Despite their solid and durable nature, hard walls can offer a degree of flexibility similar to that found in softwall and rigid wall cleanrooms. Prefabricated hardwall cleanrooms are a popular option, combining the robustness of hard walls with the convenience of modular assembly.
Temperature control is a crucial aspect of cleanroom management, as it significantly impacts the type and quality of work conducted within the environment. Effective temperature control also involves managing humidity, which is essential to prevent issues such as corrosion and condensation on surfaces and equipment. Additionally, maintaining a comfortable temperature for workers is important, as it contributes to their productivity and overall performance. Balancing these factors ensures both the integrity of cleanroom processes and the well-being of personnel.
Flooring is a critical component of a cleanroom, serving as the foundation that integrates and supports all other elements. Various types of flooring can be used, including vinyl tiles, rubber mats, and raised perforated grates or metal panels. Raised flooring, supported above the foundation, facilitates improved airflow and is particularly recommended for cleanrooms with ISO classifications ranging from ISO 1 to ISO 6. Although more costly, raised flooring is essential for maintaining optimal cleanliness and air distribution in high-standard cleanroom environments.
Airlocks are crucial in high-level cleanrooms for additional protection against atmospheric contaminants that workers might bring in on their clothing. They typically feature two or more doors that cannot be opened simultaneously, creating a controlled space to prevent contamination. Some airlocks are equipped with air showers that use powerful jets of air to remove contaminants from workers before they enter the cleanroom. For cleanrooms with high ISO classifications, such as ISO 2 and ISO 3, multiple airlocks are often employed to enhance contamination control and maintain stringent cleanliness standards./p>
Cleanroom World is a comprehensive supplier specializing in all aspects of cleanroom construction and design. They offer a wide range of products, including clothing, equipment, filters, ventilation systems, and other essential components. The company excels in modular, portable, and softwall cleanrooms, with ISO classifications ranging from ISO 4 (Class 10) to ISO 8 (Class 100,000). Their modular cleanrooms are utilized across various industries, including semiconductor manufacturing, aerospace, medical device production, and pharmaceuticals. Cleanroom World provides everything needed to build and maintain a contaminant-free environment, supporting the creation of high-quality cleanroom spaces.
Clean Rooms International offers a comprehensive range of cleanroom solutions, including workstations, components, and air handling equipment. The company provides a suite of services such as testing, accreditation, certification, and consulting to help customers develop optimal cleanroom solutions. With over 40 years of experience, Clean Rooms International is renowned for its ability to create innovative solutions for complex and unique challenges. Their expertise spans various industries, including aerospace and animal husbandry, and they are equipped to address and resolve a wide array of cleanroom-related issues.
CleanZone is a cleanroom supplier and manufacturer specializing in the design, construction, and installation of cleanrooms ranging from ISO 5 (Class 100) to ISO 8 (Class 100,000). The company handles every aspect of cleanroom installation, using high-quality materials such as wall panels, ceiling grids, doors, pass-throughs, and windows. CleanZone serves a diverse clientele, including universities, medical marijuana facilities, and the electronics industry. The company is committed to delivering comprehensive services while ensuring that solutions are tailored to fit within the customer's budget.
American Clean Room Systems specializes in providing cleanroom solutions tailored to the pharmaceutical and medical industries, as well as other specialized sectors. As a full-service cleanroom manufacturer, the company offers comprehensive engineering and design services, including flooring, monitoring systems, and laminar flow equipment. American Clean Room Systems focuses on helping customers quickly install and certify cleanrooms that meet all relevant specifications and standards. Adhering to both national and international standards, the company provides detailed guides to enhance customer understanding. They are committed to installing and setting up cleanrooms with minimal disruption to ongoing operations.
Allied Clean Rooms is a modular cleanroom manufacturer specializing in custom-designed and constructed cleanrooms tailored to meet the specific needs of their clients. The company adheres to Current Good Manufacturing Practices (CGMP) guidelines, ensuring compliance with standards for pharmaceutical packaging, medical instrument production, and food production equipment. Allied Clean Rooms provides installations for cleanrooms with ISO classifications ranging from ISO 4 to ISO 8. In addition to modular cleanrooms, they offer freestanding softwall cleanrooms with steel or aluminum frames, providing flexible options to suit various requirements.
As technology advances and sensitive equipment becomes more prevalent, cleanrooms are increasingly essential across various industries. Workspaces that are free from dust, microbes, and particulate matter are crucial for electronics production, medical instrument manufacturing, and medication formulation. Modern manufacturing emphasizes creating stronger, more durable products with minimal potential for defects or hazards, which is best achieved in highly controlled environments. Cleanrooms provide the precise conditions needed to produce high-quality, defect-free products.
Cannabis, due to its medicinal use and methods of ingestion, must adhere to stringent sanitary standards similar to those in the pharmaceutical industry. Cannabis cleanrooms are required to meet high cleanliness and hygiene standards to ensure public safety. With the legalization of cannabis, it is now subject to guidelines established by the FDA and EU GMP, which set forth rigorous requirements for the handling and production of medicinal products. These regulations ensure that cannabis is processed and managed with the utmost care to maintain its quality and safety.
While cannabis cleanrooms share similarities with pharmaceutical cleanrooms, they also face unique challenges due to the nature of the materials involved. Pharmaceutical cleanrooms must manage powders, chemicals, and airborne contaminants. In contrast, cannabis cleanrooms must address specific issues related to plant cultivation, such as mites, insects, cross-pollination, and microbial contamination associated with agriculture. These factors necessitate tailored measures to maintain a contaminant-free environment while accommodating the unique needs of growing and processing cannabis.
In addition to managing plant-related contaminants, cannabis cleanrooms must address the challenges of bucking and drying, which necessitate precise control of temperature and humidity. The robust nature of cannabis production demands cleanrooms that are exceptionally durable and able to withstand these rigorous conditions. Most cannabis cleanrooms are classified from ISO 5 to ISO 8, ensuring they meet the necessary standards for the safe handling and processing of cannabis products.
The production of vaccines involves handling various materials that must be processed in cleanrooms to ensure safety and efficacy. The production process can vary significantly: some companies manage the entire vaccine production cycle in-house, while others may outsource the manufacturing of vaccine components. Additionally, the type of vaccine being produced—such as viral, plant-based, or RNA vaccines—determines the specific cleanroom requirements and facility configurations. Viral vaccine manufacturers, for instance, use different facilities compared to those producing plant-based or RNA vaccines, each tailored to meet the unique needs of their respective production processes.
A critical aspect of vaccine production is the variety of components involved, which can range from live organisms to inert proteins. This diversity significantly influences the design and certification of vaccine cleanrooms. Each stage of vaccine manufacturing necessitates the use of cleanrooms to ensure product safety and efficacy. Like all cleanrooms, those used for vaccine production must maintain precise control over temperature, humidity, airflow, and air pressure. Additionally, they incorporate stringent safety measures to protect workers and maintain the integrity of the production environment.
Cleanrooms are essential for vaccine production, as they ensure the highest levels of hygiene and control throughout the manufacturing process. Regulatory and oversight agencies rigorously monitor these procedures to ensure vaccine viability and public safety. Since every stage of vaccine production occurs within a cleanroom, maintaining the integrity of these environments is crucial and held to the highest standards.
The pharmaceutical industry manages a broad array of chemicals, compounds, and powders, many of which are hazardous and pose significant risks. This includes hazardous drugs, which present particular challenges related to their production, storage, and handling. Proper procedures and stringent safety measures are essential to mitigate these risks and ensure the safety of both personnel and the integrity of the pharmaceutical products.
Cleanrooms for hazardous drugs must be rigorously isolated from the rest of the facility to prevent contamination and protect both personnel and the environment. These cleanrooms incorporate all standard cleanroom features, but with additional precautions tailored for the safe handling of dangerous materials. Given the high risk associated with hazardous pharmaceuticals, these cleanrooms must adhere to the most stringent security and containment protocols. This includes enhanced control measures and highly restrictive conditions to ensure the safety of both the products and the individuals involved in their production and handling.
The National Institute for Occupational Safety and Health (NIOSH) defines a hazardous drug based on criteria such as carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity, genotoxicity, or the presence of structural characteristics similar to known hazardous drugs. USP 800 outlines the specific requirements for personnel handling hazardous drugs, including protocols for deactivating, decontaminating, and cleaning hazardous pharmaceutical cleanrooms. These standards ensure the safe management of hazardous drugs and maintain the integrity of the cleanroom environment.
The primary concern with hazardous drugs is the safety of personnel handling them, as direct contact with these drugs poses significant risks. To mitigate these dangers, USP 800 provides detailed guidelines on the appropriate protective clothing for workers. It specifies the types of personal protective equipment (PPE) required and mandates that this clothing be rigorously tested to ensure its effectiveness in protecting against hazardous drug exposure.
Cleanrooms used in food production are designed to manage airborne contaminants and pathogens, similar to other cleanroom environments. However, their purpose extends beyond merely controlling contamination during processing. They also play a critical role in ensuring the stability and shelf life of the food product, as any contamination can significantly reduce its usability. With the increasing consumer demand for foods with natural ingredients, maintaining a controlled environment during food preparation has become even more crucial.
Using cleanrooms in food production presents challenges due to the high production rates and the frequent handling of food products before packaging. These factors necessitate rigorous monitoring and control, along with specialized equipment, to ensure the cleanroom environment remains compliant with standards. Despite these challenges, cleanrooms are essential in the food industry for extending the shelf life of products and maintaining their quality.
Cleanrooms are crucial in food processing for ensuring safety, extending shelf life, and maintaining quality. They are as vital to the food industry as oxygen reduction, ingredient selection, formulation, and timely distribution. Among the various types of cleanrooms used in food processing, softwall cleanrooms are the most common due to their affordability, ease of installation, and flexibility. Rigidwall cleanrooms offer a middle ground between the cost-effectiveness of softwall and the durability of hardwall cleanrooms. While hardwall cleanrooms are used in the food industry for their robust structure, they are generally more expensive and less adaptable to changes in food production needs.
A cleanroom is a specially designed enclosed space where airborne particulates have been limited or removed by a highly sophisticated filtration system. They are used by industries that require a highly controlled and monitored environment for the production...
Cleanroom products are specially designed and engineered to prevent the contamination and pollution of highly sensitive cleanroom environments. For a cleanroom to receive its level of classification, it is required to be cleaned, constructed, and sanitized to meet a list of qualifying conditions and standards....
A modular clean room is a prefabricated, controlled environment that is constructed to limit the presence of sub-micron particulates. These specially designed rooms are assembled using prefabricated panels inserted into a frame. They are purchased as a kit to be assembled or can be constructed by a technician...
A portable cleanroom is a compact system that requires little space, provides mobility, is cost effective, and offers exceptional clean and filtered airflow to create an uncontaminated and sanitized environment. They are a modular designed room where...
A softwall cleanroom is a confined controlled space with a metal frame, clear panel walls, an entrance, high efficiency particulate air (HEPA) filters, and exceptional lighting that is designed to provide a contaminant and particulate matter free workspace...
An altitude chamber is a test chamber that is designed to simulate the altitude, vacuum, and temperature of environmental conditions at heights that match the flight patterns of all forms of aircraft, from commercial to military...
A climate chamber is an enclosed space that provides a controlled set of circumstances for testing the impact of various environmental and climatic conditions on industrial goods, commercial products, electronic devices, materials, and biological matter...
A cold room is a temperature controlled environment that is capable, through refrigeration, to create conditions for storage, experimentation, and preservation of foods, equipment, and medical supplies. The types of cold rooms are...
An environmental chamber is an enclosure used to test the effects of a variety of conditions on a product, component, part, or assembly. These highly technical pieces of equipment are capable of simulating the types of conditions a product may face while in use...
A HEPA filter is a high efficiency pleated air filter capable of capturing extremely small particulate matter down to particles that are the size of a micron (µ), or a micrometer, which is 1/1000th of a meter...
A humidity chamber is a mechanism that examines how products react when exposed to variations in humidity. This type of environmental testing is used by manufacturers to test the various parameters of their products in the harshest of conditions...
Modular buildings are buildings made up of standardized sections, called "modules," manufactured in a controlled environment of a factory away from the building's future location. The common factory-made, standard modules include walls...
A portable office is a mobile workspace that can be easily assembled and placed to provide a quiet and convenient location for meetings, completing paperwork, or examining plans. They are built using...
Prefabricated buildings, or prefabs, are buildings with components (walls, roof, and floor) that are manufactured in a factory or manufacturing plant. These components can be fully or partially assembled in a factory which is then transferred at the construction site...
Stability chambers and rooms are climate-controlled environments that provide stable conditions for testing and storage. These specialized environmental chambers offer a precise, raised temperature or humidity to ascertain whether a...
A temperature chamber is a controlled environment capable of producing conditions that a product will encounter during its use. These highly controlled technical tools are able to produce the types of hazards, uses, and atmospheres a product may endure...
A test chamber is a managed and controlled environment used to test the endurance, stability, and practicality of equipment, products, and chemicals. They are a controlled enclosure that mimics the effects of environmental conditions that a product may encounter during its usage...
Thermal shock chambers are climatic chambers for thermal shock testing that are utilized to put the material to serious shocks. This is accomplished through the repeated and sudden passage to low temperature areas from...
A vacuum chamber removes air and pressure from a confined enclosure to test the effects of a vacuum on parts, materials, components, and assemblies. It can also be used to test the performance of applications for manufacturing operations...
The purpose of an environmental testing chamber is to examine the effects of a variety of climactic, physical, and other unique conditions on a product. They are designed to create environments that a product may encounter during its use...