Types of Cleanrooms: Discover Their Classifications and Applications
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Introduction
This Article takes an In-depth look at the Types of Cleanrooms
You will learn more about topics such as:
What is a Cleanroom?
Requirements for a Cleanroom
Cleanroom Applications
Types of Clean Rooms
Cleanroom Supplies
Important Cleanroom Considerations
What is a Cleanroom?
A cleanroom is a specially designed and configured room that has been constructed to eliminate dust particulates and atmospheric contaminants. They are commonly used for scientific research, pharmaceutical production, and other industries that produce products that can be damaged by unsanitary or polluted conditions.
The classification of a cleanroom is based on the concentration of particulate matter (PM) in the air, which includes both particles and liquids per cubic meter. For comparison, the air we breathe typically contains about 35 million particles per cubic meter, with each particle being approximately 0.5 micrometers (μm) in size, or one-millionth of a meter.
Cleanrooms are classified by the International Organization for Standardization (ISO) using a grading system that ranges from ISO 1, representing the highest level of cleanliness, to ISO 9, indicating a less stringent level of cleanliness. The classification is based on the size and concentration of particles present in the air within the cleanroom.
The United States used Federal Standard 209E for cleanroom classification, which was published by the Institute of Environmental Sciences and Technology (IEST) in 1963. This system ranged from Class 1, equivalent to ISO 3, to Class 100,000, equivalent to ISO 8. Although several countries continue to use the IEST system, it was officially retired in 2001 due to its obsolescence.
For many years, scientists, engineers, and designers struggled to create a contaminant-free environment due to issues with uncontrollable particles and airflow. In 1960, physicist Willis Whitfield developed a groundbreaking filtration system that paved the way for the modern cleanroom.
Requirements for a Cleanroom –
Cleanrooms are used by specialized industries, such as pharmaceutical, biotech, semiconductors, laboratories, microchip producers, and photovoltaic. Any manufacturing process requiring strictly controlled production and product handling will have some form of cleanroom. The nature and delicacy of a product determines the level of cleanroom required.
The requirements for a cleanroom start with ensuring staff protection. Personnel must wear protective clothing and accessories designed to prevent contamination. These items, typically made from durable synthetic materials, are intended for single-use only. Additionally, everything that enters the cleanroom must be meticulously classified and approved, with attention to even the smallest details.
Cleanrooms are designed without traditional furniture. Their surfaces are free from bolts, nuts, visible joints, or any features that could trap dust particles. Equipment and surfaces are smooth, highly polished, and typically made from plastic or high-grade stainless steel. The overall design and construction of cleanrooms are intentionally minimalistic and straightforward to minimize contamination risks.
Cleanroom lighting is designed to provide adequate illumination for smooth operation while adhering to stringent hygiene standards. It is crucial that the lighting systems require minimal maintenance and have a long lifespan, as frequent cleaning of the interior can necessitate recertification of the cleanroom.
The most critical feature of cleanrooms is their air circulation system. This system, which controls air movement with precision, often employs unidirectional airflow, where air enters through the ceiling and exits through the floor. To maintain cleanliness, negative pressure is used to prevent contaminants from escaping and to keep outside pollutants from entering. The specific type and design of the airflow system are determined by the nature of the materials being handled in the cleanroom.
Cleanrooms are very expensive to maintain and construct with an average cost between $100 to $150 per square foot. A ten foot by ten foot cleanroom, about the size of a small bedroom, has a cost of $10,000 to $15,000, which can be lower or higher depending on the air control system and instrumentation.
A more versatile option is the modular cleanroom, which is adaptable, easy to construct, and can be easily reconfigured or modified. Modular cleanrooms offer the same contamination-free environments as more expensive models, but at a lower cost. They combine flexibility with effective contamination control, making them a practical choice for many applications.
Clean Room Applications
During the COVID-19 pandemic in 2020, cleanrooms proved to be an essential component in the treatment and research processes. Since their development in 1960, cleanrooms have been utilized across various industries, including some that might be surprising. Below, you'll find a description of several applications of cleanrooms.
Isolation Rooms for Hospitals
Isolation rooms are a specialized type of cleanroom designed to separate patients with unique or unusual symptoms from others. These rooms share many of the same requirements as standard cleanrooms and may have an ISO rating based on their intended use. Isolation rooms are used for patients with specific medical conditions or infections affecting their skin, lungs, or intestines. The primary purpose of these rooms is to prevent the spread of disease and protect patients who are highly susceptible to infections.
The air pressure in an isolation room is adjusted based on the patient's condition. Negative air pressure is employed to prevent contaminants from escaping the room; in this setup, air is drawn into the room, filtered, and then expelled outside. Conversely, for patients with weakened immune systems, positive air pressure is used to protect against external contaminants. In this case, air is pushed into the room through HEPA filters to ensure it remains free of infectious agents.
These unique rooms have been designed by the collaboration of healthcare workers and clean room engineers. They have alarms to detect pressure loss, hands free showers and toilets, and no circulating air. They use high efficiency particulate air (HEPA) filters that are designed to remove dust, pollen, mold, bacteria, and any particles that are 0.3 µm.
Semiconductor and Microelectronic
The sensitive and delicate nature of electronics manufacturers' equipment demands very stringent environmental controls. Any defects or deficiencies in a clean room can greatly affect a production run. The clean rooms for these manufacturers are air tight, have UV filtered light, and control mechanisms for electrostatic charges. Unlike most clean rooms, ones for the electronics industry are larger and more spacious.
In the semiconductor and microelectronics industries, the integrity of products can be significantly compromised by even the smallest microscopic particles. Just one tiny particle can cause major issues, such as haze on optics, leading to increased cleaning costs. Cleanrooms for these industries must meticulously address every aspect of their design and construction, including wall materials, airflow, power supply, lighting, storage, and production areas. The challenge is further heightened by the cleanroom's size and the number of workers it accommodates, which adds complexity to maintaining a contaminant-free environment.
In the semiconductor and microelectronics industries, cleanrooms aim for an ISO level 3 or 5 rating. Achieving this level of cleanliness involves the use of gowning rooms, anterooms, airlocks, pass-throughs, and specialized window modules. To maintain the desired cleanroom standard, stringent controls are required, making it a challenging and ongoing task.
Each cleanroom designed for the semiconductor and microelectronics industries is unique, tailored to the specific products being manufactured and the processes employed. This necessitates the expertise of design specialists who are well-versed in the specific requirements of semiconductor and microelectronics construction. Often, this involves creating environments suitable for working with components under magnification and maintaining a noiseless atmosphere.
Medical Device Manufacturing
Medical devices are assembled and manufactured in controlled cleanroom environments to ensure their quality and integrity. Given that these devices are designed to assist patients and prevent illness, the manufacturing environment must adhere to the highest cleanliness standards. This necessity makes cleanrooms a critical component in the production process for medical devices.
Unlike other cleanrooms used in manufacturing, cleanrooms for medical device production face rigorous scrutiny from regulatory agencies due to the direct impact these devices have on public health. While ISO standards set the classification and specific requirements for cleanrooms involved in medical device manufacturing, companies must also adhere to stringent governmental regulations. This regulatory oversight introduces additional complexities and necessitates regular inspections, adding to the challenges of maintaining compliance in medical device production.
In addition to government regulations, international standards administered by the World Health Organization (WHO) must also be adhered to. These specifications for medical device cleanrooms include detailed requirements covering aspects such as room size, contents, location, filtration systems, and the attire of workers. Strict compliance with these standards is essential to maintain production and ensure the safety and efficacy of medical devices.
Medical device cleanrooms are designed to control airborne particulates and microorganisms. They are also monitored for bioburden, which measures the number of bacteria present on surfaces. Over the years, the demands and regulations for medical device manufacturing have become increasingly stringent. Class III medical devices, which are implanted in the body or sustain life, are subject to the highest level of control and oversight.
Compounding Pharmacies
Pharmaceutical cleanrooms adhere to stringent standards similar to those for medical devices, given their crucial role in public health. The United States Food and Drug Administration (FDA) sets and periodically updates these standards. Pharmaceutical cleanrooms are meticulously designed to control factors such as humidity, which can affect product integrity, as well as air pressure, microorganisms, and temperature to ensure the highest quality and safety of pharmaceutical products.
Pharmaceutical cleanrooms require meticulous attention to detail and rigorous scrutiny to ensure the safety and efficacy of their products. Adhering to high-quality standards is crucial to prevent medications from posing risks to public health. Similar to the regulation of food, beverages, and medical instruments, anything that comes into contact with the public must be closely monitored and regulated to ensure safety and effectiveness.
The compounding pharmacy business has been growing over the last several years and has had restrictions placed on it due to the chemicals and compounds they produce requiring clean rooms. The unique nature of a compound pharmacy is their ability to mix, produce, and sell drugs specifically designed to meet a customer’s needs. The nature of the materials they use makes it necessary for them to have an enclosed sanitary environment. Their clean rooms need to meet the ISO standards levels 7 or 8.
Ballrooms
The ballroom cleanroom concept offers flexibility by allowing the space to be scaled up or down based on process requirements. This design enables multiple processes to be conducted simultaneously. Equipment and operations are often mounted on wheels, allowing them to be moved to different locations as needed. Additionally, a ballroom cleanroom doesn't have to be a single large area; it can consist of adjacent smaller spaces connected by through-wall connectors, a setup known as a "dance floor" arrangement.
The ballroom cleanroom concept optimizes space utilization and reduces capital expenditure by providing flexibility to adapt to changing product and customer needs. This design allows for all personnel and equipment to be located in a single, easily accessible space, facilitating efficient operations. The layout enables a sealed and enclosed environment where a complete set of operations can be carried out without the need to move products between different sealed areas.
This class of cleanroom is used for full-scale production operations involving precision products. Unlike mini-environments, which are designed for specific tools or processes, ballroom cleanrooms are expansive and support comprehensive production activities. The primary challenge of ballroom cleanrooms is maintaining a completely contained environment that is free of contaminants.
Leading Manufacturers and Suppliers
Cleanroom Components and Classification
High Efficiency Particulate Air (HEPA) Filters
TThe most crucial component of a cleanroom is its filtration system, which starts with HEPA filters designed to capture particles as small as 0.3 μm. To qualify as a HEPA filter, it must remove 99.9% of contaminants. Cleanrooms typically use multiple filters, including prefilters that capture larger particles before the air flows through the HEPA filter, ensuring a high level of air cleanliness.
Most cleanrooms, whether softwall or hardwall, are designed with filters installed in the ceiling to facilitate downward airflow. This setup is compatible with both recirculating and unidirectional airflow systems. A key factor in determining a cleanroom's classification is its air change rate, which can be as high as 300 cubic feet per minute, depending on the efficiency of the HEPA filters used.
Cleanroom Ceilings
Cleanroom ceilings typically feature drop ceilings made from acoustical panels suspended on a tightly fitted grid, and they are usually available only in white. These ceilings can be either high or low, depending on the room's specifications. The precise fit of the tiles helps to prevent the entry of dust, moisture, or contaminants, maintaining the cleanliness of the environment.
As with many of the components of a cleanroom, ceiling grids are made of high quality aluminum or stainless steel. When tiles are installed on the grid, they are sealed with a gel or rubber gasket around their edges.
Lighting in a cleanroom tends to be the last consideration of its design. Though the lux level, or level of light intensity, may be one consideration, it is important to construct the lighting such that it does not interfere with the airflow and filtration systems. LED lights are the most practical choice since they have a linear shape and can be surface mounted between HEPA and ULPA filters. If at all possible, roof placement of lighting is the best alternative since it can be cleaned or replaced without disturbing the integrity of the cleanroom.
In the production of cleanroom ceilings, manufacturers start with large sheets of raw material, which are cut into uniform shapes and sizes. After cutting and shaping, sealing material is applied to ensure a tight fit. This meticulous process ensures that the tiles fit precisely together, preventing gaps that could allow dust or contaminants to enter the cleanroom.
Ceiling Tiles
Cleanroom ceiling tiles come in various types and sizes, commonly made from vinyl-coated gypsum or mineral fiber. These tiles must be washable and resistant to soil, chemicals, solvents, rust, and corrosion. When maintained properly, they are water-repellent and resistant to scratches, ensuring long-term durability and cleanliness.
Gypsum ceiling tiles typically have a thickness of ½ inch, while mineral fiber tiles can be up to ⅝ inch thick. Gypsum tiles feature a white vinyl finish that is durable, stain-resistant, and easy to clean. Additionally, ceiling tiles are designed to be light-reflective and noise-suppressing, which are important attributes for specialized applications.
A crucial feature of cleanroom ceiling tiles is that they do not shed particles into the environment, which is achieved through the vinyl coating. While vinyl is a common coating, other materials such as aluminum, polycarbonate, stainless steel, and fiberglass reinforced plastic (FRP) can also be used. Vinyl-coated ceiling tiles, with their sealed back and edges, are suitable for ISO 5 (Class 100) cleanrooms and comply with USDA and FSIS standards for use in food processing cleanrooms./p>
All types of cleanrooms, regardless of their specific use or configuration, are equipped with ceiling tiles. These tiles are designed to be washable, scrubbable, and resistant to soil, making them suitable for various industrial applications, from food processing to chemical laboratories. They are securely installed within a cleanroom grid system to help prevent contamination. Regardless of the material used, cleanroom ceiling tiles are engineered to meet the standards of the cleanroom class and support its specific processes.
Cleanroom Classifications
To have a room classified it has to meet the standards of the International Organization of Standardization or ISO, which was founded in 1947. The founding purpose of this voluntary organization was to establish international standards covering aspects of scientific research and delicate business practices. Though membership has been voluntary, the standards established by the ISO have become the foundational principles that worldwide organizations adhere to. Over the years, the ISO has created over 20,000 standards for member nations to use as a guide when working with chemicals, volatile materials, and sensitive instruments.
Class 100 Clean Rooms
Class 100 clean rooms are the third highest classification in Federal Standard 209 standards. In order to meet regulations, a Class 100 standard clean room must never exceed 100 particles per cubic foot (the particles being 0.5 microns or larger). As a reference point for just how small 0.5 microns is, the average human hair is approximately 75-100 microns in width.
Due to the stringent standards and regulations that Class 100 cleanrooms must adhere to, the materials used in their construction are limited. Common materials for panels and walls in Class 100 cleanrooms include white acrylic, steel, stainless steel, aluminum, and polycarbonate. Additionally, the materials brought into the cleanroom are also subject to strict regulations to maintain the required level of cleanliness.
Class 1,000 Clean Rooms
Class 1,000 clean rooms are rooms in which the concentration level of airborne particles is controlled so that they never exceed 1,000 particles per cubic foot. Class 1,000 clean rooms are the second lowest classification in Federal Standard 209 standards. The International Organization for Standardization (ISO) equivalent standard of Class 1,000 clean rooms is ISO 6.
Class 1,000 cleanrooms are used for a range of applications, including inspection, patterning, and integration tasks such as non-contact profilometry, flip-chip integration, thin-film deposition, and laser micromachining. Due to their versatility, Class 1,000 cleanrooms find applications across various industries, including pharmaceuticals, scientific research, medical fields, electronics, semiconductors, food processing, and industrial manufacturing.
Class 10,000 Clean Rooms
Class 10,000 clean rooms are rooms in which the concentration of airborne particles is never allowed to exceed 10,000 particles per cubic foot. The Class 10,000 designation and all the other airborne cleanliness classes in clean rooms and zones name their classes after the maximum number of particles allowed in the rooms at one time.
TThe primary function of cleanrooms is to continuously filter the air to prevent tiny particles from damaging highly sensitive technologies. In a Class 10,000 cleanroom, the air is changed 40-60 times per hour. Although this class does not have as stringent limitations and rules as higher classifications, there are still specific procedures for cleaning, movement, and clothing that must be followed to minimize contamination.
Cleanroom Equipment
Cleanroom equipment is movable items that are not attached to the walls, floor, or ceiling. They can include shoe cleaners, showers, containment hoods, cabinets, monitoring systems, particle counters, spray guns, flow hoods, pass throughs, and UV disinfection units. Small items such as bottles, dispensers, bags, sheets, disinfectants, gloves, and tape may also be present and must be purchased from a cleanroom supplier.
Here is a brief list of some equipment typically found in a cleanroom:
Automatic Shoe Cleaners
Every aspect of a cleanroom occupant must be meticulously cleaned before entering the cleanroom. One of the greatest challenges in cleanroom maintenance is preventing contaminants from personnel from affecting the environment. A significant concern is the potential for materials collected on shoes to introduce pollutants. In extreme cases, personnel are required to remove their shoes before entering the cleanroom and change into specialized footwear provided in a designated cloaking room.
Automatic shoe cleaners are designed to remove large particles and debris from the bottom and sides of shoes. The cleaning process is straightforward: employees place their feet into a box-like vacuum that sucks loose material off the shoes and deposits it into a disposable collection bag. While there are various shoe cleaning methods available, automatic shoe cleaners are particularly effective because they clean the entire shoe, not just the soles.
Automatic shoe cleaners have external and built-in vacuums and may include HEPA filters. They can be self-contained in the clean room, a pass through, or connected to an external collection system. Automatic or motorized shoe cleaners are capable of cleaning any size or design of shoe. They can be attached to a clean room as part of its structure.
Clean Room Pass Throughs
A pass-through's function is to minimize the amount of traffic entering a cleanroom. It helps control and reduce potential contaminants by providing a sealed, structured opening for transferring documentation, tools, and other materials necessary for cleanroom operations.
Cleanroom personnel are trained in the specific protocols and standards required for their roles. However, there may be occasions when untrained individuals need to access the cleanroom for various reasons. Pass-throughs allow these individuals to provide information or deliver materials to trained staff without entering the cleanroom itself. In this way, pass-throughs enhance the efficiency of cleanroom operations by minimizing unnecessary contamination risks and streamlining communication.
Pass-throughs come in various designs, including models mounted in the middle of a wall or those large enough to accommodate carts. Their design is tailored to the ISO rating of the cleanroom and the specific operations conducted within it. Pass-throughs may feature additional components such as showers, HEPA filters, and UV sanitizing modules. They are an ideal addition to cleanrooms, optimizing space while facilitating easy access and maintaining stringent cleanliness standards.
Pass-throughs are known by various names, including doors, windows, and chambers. They function as airlock chambers to efficiently transfer materials and parts into and out of a cleanroom. By minimizing contamination between rooms and reducing traffic within the cleanroom, pass-throughs play a crucial role in maintaining stringent cleanliness standards.
Containment Hoods
Cleanrooms are the most hygienic controlled environments in manufacturing, designed to provide a safe, microbe-free workspace for technical and biochemical work. Despite their high standards, certain aspects of cleanroom operations require additional protection. In these cases, advanced environmental control is necessary, which is provided by containment hoods. These hoods offer an extra layer of protection to maintain the integrity of the cleanroom environment.
Containment hoods in cleanrooms come in various shapes and designs to address specific needs. The most common type is the laminar flow hood, which includes vertical and horizontal flow hoods. These are used in environments where vapors, solvents, chemicals, and fine powders are present. Other types of containment hoods include biological safety hoods, fume hoods, solvent hoods, and wet processing fume hoods. These hoods are essential additions to cleanrooms, providing both enhanced protection for personnel and a controlled environment for performing individual technical tasks.
Containment hoods are pressurized units with a single HEPA filter and ducting to an external exhaust system. The fan in the hood pulls air away from the operator across the workspace and through the filter. The powerful fans are adjustable and designed for pharmaceutical compounds, powder weighing, and measuring drug dosages. They are available in sizes ranging from 2 feet to 4 feet and can be full sized hoods like cabinets or countertop hoods.
Particle Counters
Particle counters are used in cleanrooms to measure the size and number of airborne particles. They can detect particles as small as 0.1 micron (µ) and as large as 5 µ. The particle size and count are critical for determining the cleanroom's classification and ensuring it meets certification requirements, which specify acceptable limits for particles within a given volume. Additionally, the data from particle counters helps determine the effectiveness of HEPA filters and whether additional filtration is needed to maintain the desired cleanliness levels.
Light scattering is employed to measure particle size using a laser sensor block in a particle counter. This block includes a laser diode, sample inlet and exhaust, volume view, sensor cavity, sensor optics, and a photodetector. Air is moved through the sensor block, where particles scatter the laser light. The scattered light is then analyzed to determine the size of the particles, allowing for precise measurement and monitoring.
In a particle counter, a pump creates a vacuum that draws a sample of air through the inlet and across the laser diode. As the air flows through the inlet, it is compressed to ensure accurate particle measurement. When the air passes through the laser beam, particles within it cause the light to scatter. Larger particles reflect more light. The photodetector captures the scattered light and converts its energy into data, which is then used to quantify the size of the particles.
Airborne particle counters are essential for monitoring, classifying, and diagnosing contamination sources in cleanrooms. There are two main types of particle counters: condensation and optical. Condensation counters detect ultrafine particles that optical counters might miss.Optical particle counters, also known as light scattering counters, are the most commonly used. They measure the number of particles by detecting the light scattered when particles pass through a beam of light.
Desiccator Cabinet
Desiccator cabinets are a controlled environment used for long term storage of items that degrade if left in atmospheric humidity. The interior of a desiccator cabinet is exceptionally dry or a nitrogen environment that is tightly sealed and purged. Desiccator cabinets are built with a stainless steel outer shell and dividers between the various compartments. The stainless steel structure is made of high quality stainless steel that won’t crack, degrade, or rupture.
Stainless steel is used in the construction of desiccator cabinets due to its durability and long-lasting performance, which are crucial for maintaining the cabinet’s integrity. Its strength allows it to withstand the pressure generated by the sealed compartments of the cabinet. Additionally, stainless steel is used for the separators between the individual sections, ensuring reliable performance and structural stability.
The success of a desiccator cabinet relies on its tight seal, essential for preserving the contents. Desiccator cabinets can be constructed from welded stainless steel or tightly sealed clear acrylic, a non-outgassing material. Acrylic cabinets offer the advantage of easy observation and monitoring of the contents. The doors of desiccator cabinets are equipped with a spring-loaded latch and a gasket that ensures an airtight, even seal.
A crucial feature of desiccator cabinets is protection against electrostatic discharge (ESD), which can damage sensitive contents. In cleanroom environments, many tools and equipment are highly sensitive to electrical interference, which can impair their functionality. Desiccator cabinets are designed with an electrostatic decay rate of 0.05 seconds, as specified by Federal Test Standard 1001C, and a surface resistance of 10^6 to 10^8 Ohms (Ω) per square, ensuring effective ESD protection.
Clean Room Air Showers
Cleanroom air showers are designed to remove particulate matter from personnel before they enter a cleanroom. These self-contained units feature an air circulation system and are positioned at the cleanroom entrance. Given that people are a primary source of contaminants, air showers effectively and efficiently remove particulate matter from workers, ensuring they enter the cleanroom with minimal risk of introducing contaminants.
The operation of an air shower is similar to that of a car wash, involving multiple steps for effective decontamination. When the air shower door opens, a sensor activates an interlock magnet that locks both the shower and the cleanroom doors. High-velocity nozzles then blow HEPA-filtered air at the worker, creating a scrubbing effect that dislodges particulate matter from their garments. The cleaning process typically lasts four to eight seconds, followed by an additional two to four seconds for removing contaminants from the shower itself. After the cleaning cycle is complete, an indicator light is activated, signaling that the cleanroom door can now be opened.
Cleanroom air showers are tailored to meet the specific needs of various industries and the volume of personnel using them. The 90-degree design, where personnel enter from one side and exit to the right or left, allows for nozzles to be placed on opposing walls, providing comprehensive coverage. This contrasts with the straight-through design. Other configurations may include double or triple doors and can incorporate additional features such as parts cleaning, conveyors, pallets, and options for continuous operation.
Environmental Monitoring Systems
Environmental monitoring systems offer real-time readings of particle contamination, complete with alarms and feedback mechanisms. These systems enable rapid response to any contamination issues. They integrate counters, sensors, and software to continuously stream data on the cleanroom's environmental conditions, ensuring constant surveillance and immediate detection of any deviations.
Environmental monitoring systems present data in graphical and easy-to-understand formats, allowing for quick interpretation. The real-time nature of the data enables immediate response to contamination events, helping to prevent their spread. These systems can be seamlessly integrated into any cleanroom setup and include a strategic assessment of sensor placement and the types of sensors needed to ensure comprehensive monitoring.
An environmental monitoring system ensures that air pressure, temperature, humidity, and particle counts remain at required levels. The data collected is stored for extended periods and can be used to verify and substantiate the cleanroom's compliance with ISO standards.
To maintain a cleanroom's classification, several critical areas must be continuously monitored. An environmental monitoring system regularly checks personnel for contaminants, as they are a primary source of particulate matter. The system also monitors floors, walls, ceilings, and equipment to ensure thorough cleaning. Additionally, it assesses the air quality by passing air samples over a media plate, which is then incubated to detect organisms, and measures the number of particles per cubic foot or liter of air.
An aggressive environmental monitoring program provides crucial data to prevent contamination and ensure compliance with ISO and federal standards. By continuously monitoring various parameters, these programs help maintain cleanroom operations, minimizing the risk of contamination and avoiding delays in processes.
Laminar Airflow
Natural airflow is often turbulent, creating uneven patterns with eddies and vortices that can gather and deposit particles on workspaces and surfaces. In contrast, laminar airflow establishes a steady, consistent airflow pattern that mitigates the effects of natural turbulence. Air is drawn through a series of filters that clean, purify, and decontaminate it before it is distributed throughout the cleanroom. This controlled airflow ensures a clean environment, helping to meet stringent cleanroom standards and requirements.
The effectiveness of laminar airflow relies on its advanced filtration system. This system includes a series of pre-filters that capture large, visible particles, followed by HEPA filters that remove 99.99% of particles as small as 3 microns (µ). Once the air is thoroughly filtered, it is released into the cleanroom, ensuring it is free of contaminants. This clean air supports the production of sensitive technical products and maintains the required cleanroom standards.
Most clean rooms are classified as laminar since all clean rooms have some form of airflow control. Laminar refers to unidirectional airflow, meaning that air makes a single pass through a room. A common version is where the air enters through the ceiling and exits through outlets in the floor. In other designs, air enters through one wall and leaves through an opposite wall, which is called horizontal laminar. HEPA filters are located where the airflow enters the room. For most rooms, the ductwork is made of stainless steel or other non-shedding metal.
Cleanroom Construction and Design
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 Clean Rooms
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 Cleanrooms
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
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.
Standard Clean Room
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.
Turbulently Ventilated Clean Rooms
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
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.
Used Clean Rooms
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.
ISO Cleanroom Standards and Classification
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
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.
Cleanroom Supplies
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.
Important Cleanroom Considerations
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.
Classification
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.
Walls
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
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
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
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>
Top Clean Room Manufacturers
Cleanroom World
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.
Cleanrooms International
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.
CleanZones, LLC
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 Cleanroom Systems
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 Cleanrooms
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.
Industrial Use of Clean Rooms
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 Production
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.
Vaccine Clean Rooms
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.
Hazardous Pharmaceuticals Clean Rooms
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.
Clean Rooms for Handling Food
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.
Leading Manufacturers and Suppliers
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