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This Article takes an In-depth look at the Types of Cleanrooms
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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 determined by the amount of particulate matter (PM), a descriptor for particles and liquids in the air, per cubic meter. The air we breathe has about 35 million particles in a cubic meter with an estimated size of 0.5 μm, micrometers or one millionth of a meter.
Cleanrooms are classified by the International Organization of Standards (ISO) that uses a grading system of ISO 1, for extremely clean, to ISO 9, satisfactorily clean. The determination of the classification is decided by the size and numbers of particles in the room's air.
The United States classification system for cleanrooms was and is Federal Standard 209E published by the Institute of Environmental Sciences and Technology (IEST) in 1963. The IEST used a classification system that ran from Class 1, an ISO 3 class, to Class 100,000, an ISO 8 classification. Though several countries still use the IEST system, it was formally retired in 2001 as being obsolete.
For many years, scientists, engineers, and designers had attempted to create an uncontaminated atmosphere but failed due to problems with uncontrollable particles and airflow. In 1960, Physicist Willis Whitfield developed a filtration system that led to the development of the modern 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 begin with staff protection, who wear protective clothing and accessories to prevent contamination. Those specialized items are made from a synthetic material that is wear and tear resistant and are used only once. Anything that enters the cleanroom has to be specially classified and approved down to the smallest detail.
Cleanrooms do not have furniture. Surfaces are free of bolts, nuts, visible joints, or places that may collect dust particles. Equipment and surfaces are smooth and highly polished, usually made of plastic or high grade stainless steel. The design and construction of cleanrooms is minimalistic and uncomplicated.
Lighting for a cleanroom provides enough light for a smooth operation and follows strict hygienic requirements. It is very important that lighting does not require frequent cleaning and be longevous since interior cleaning of a cleanroom means that it has to be recertified.
The most important feature of cleanrooms is their air circulation system. Airflow comes from the ventilation system that strictly controls air movement. Some designs have air enter from the ceiling and exit through the floor, which is referred to as unidirectional. Negative pressure is applied to prevent the escape of contaminants from dangerous materials and the intrusion of contaminants from the outside atmosphere. The items being handled determine the type and kind of airflow system.
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 flexible type of cleanroom is the modular version that is adaptable, easy to construct, and can be effortlessly changed and modified. They have all of the benefits of more expensive types and produce the same contaminate free environments but at a lower cost.
During the COVID-19 scare of 2020, cleanrooms were and are an essential part of the treatment process. Since their inception in 1960, cleanrooms have found use in several industries, including some that may seem a bit unexpected. Below is a description of some of the uses of cleanrooms.
Isolation rooms are a special form of clean room that is designed to separate patients with unique or unusual symptoms away from other people. The requirements for an isolation room are very similar to those for all other forms of clean rooms and may have an ISO rating depending on the function of the room. Patients placed in isolation rooms have specific medical conditions or infections on their skin, in their lungs, or intestines. This special form of clean room prevents the spread of disease and includes patients that get easily infected.
The type of air pressure for an isolation room varies in accordance with the type of illness the patient has. Negative air pressure is used to prevent contaminants from escaping the room. Air is pulled into the room and filtered before it is forced outside. In cases where a patient has a weakened immune system, positive air pressure is used to prevent contagious diseases from entering the room. Positive air pressure pumps air through a set of HEPA filters into the room.
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.
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.
The integrity of products for the semiconductor and microelectronics’ industry can severely suffer if contaminated with microscopic particles. One minute particle can cause significant problems such as haze on optics, which increases cleaning costs. Clean rooms for semiconductors and microelectronics have to consider every aspect of clean room construction including wall materials, air flow, power, lighting, storage, and production areas. This is further exacerbated by the size of the clean room that houses several workers.
The goal of clean rooms for the semiconductor and microelectronics industry is an ISO level 3 or 5 rating and includes the use of gowning rooms, anterooms, air locks, pass throughs, and specialized window modules. To achieve the desired clean room level, strict controls are maintained, which is difficult and a constant issue.
Every clean room constructed for semiconductors and microelectronics is unique and needs to be installed in accordance with the types of products being manufactured and the processes being used. This requires the use of design specialists that are familiar with the parameters of semiconductor and microelectronics’ construction, which, in many cases, involves working with products assembled under magnification and conducted in a noiseless environment.
Medical devices are assembled and manufactured in controlled clean room environments to ensure their integrity. Since the goal of medical devices is to help patients and prevent illness, where the devices are manufactured has to have the highest standards for cleanliness. This factor makes clean rooms used in their production a key element in the process.
Unlike other clean rooms for manufacturing, medical device clean rooms come under intense scrutiny by regulatory agencies that monitor any form of tool that will come in contact with the public. Although ISO standards determine the classification of a clean room and have specific standards for medical device manufacturing, companies still have to comply with governmental oversight. This aspect of medical instrument production creates complications and regular inspections.
Aside from the standards established by governmental agencies, there are international standards that must also be followed that are administered by the World Health Organization (WHO). The specifications and standards for medical device clean rooms cover the most minute details regarding the size, contents, location, filtration, and clothing of workers that have to be strictly followed in order to continue production.
Medical device clean rooms are designed to control airborne particulates and microorganisms. Additionally, they have to be checked for their bioburden rate, the number of bacteria living on a surface. The demands and regulations for medical device manufacturers has steadily risen over the last few years. Class III medical devices, ones that are implanted or sustain life, are the most stringently controlled.
Stipulations for pharmaceutical clean rooms follow similar stringent standards as those set for medical devices since they have the same relationship with the public. The standards for pharmaceutical clean rooms are set by the United States Food and Drug Administration (FDA) that regularly adjusts and edits its standards. Clean rooms for the pharmaceutical industry are designed to control humidity that can impact product integrity, air pressure, microorganisms, and temperature.
Meticulous detail and minute scrutiny are a common aspect of pharmaceutical clean rooms to ensure the safety and effectiveness of its products. The adherence to high quality is necessary to prevent medications from being a danger to the public. As with food, drink, and medical instruments, any thing that comes in contact with the public has to be closely regulated.
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.
The ballroom clean room concept makes it possible to scale up or scale down according to the needs of a process. Multiple processes are completed at the same time. Operations or functions are placed on wheels and wheeled to where they are needed. Additionally, a ballroom does not have to be a single large space but can be adjacent smaller spaces connected with through the wall connectors, a concept that is known as a dance floor.
The use of ballrooms maximizes the use of space while lowering capital expenditure. The focus of ballroom clean rooms is to be flexible to meet the changing requirements of products and customers. All personnel and equipment are located in one space with easy access to all operations. The design of a ballroom clean room makes it possible to have a sealed and enclosed space that is capable of completing a full set of operations without having to shift products to various sealed locations.
This class of clean room is used for full scale production operations for precision products. They are unlike mini environments that are designed for the production of one tool or process. Ballroom clean rooms are large with complete production operations. Their major problem is their ability to produce a completely contained environment that is free of contaminants.
The most important part of a cleanroom is its filtration system, which begins with HEPA filters that are designed to remove the smallest of materials down to 0.3 μm. For a filter to be classified as a HEPA filter, it must be able to remove 99.9% of contaminants. Under normal conditions, cleanrooms have multiple filters with prefilters designed to remove large particulate matter before the airflow passes through a HEPA filter.
The design of most cleanrooms, softwall or hardwall, places filters in the ceiling of the cleanroom for a downward airflow. This design is used with recirculating airflow systems and unidirectional ones. One of the factors used to determine the classification of a cleanroom is its air change rate, which can be 300 cubic feet per minute and relies on the efficiency of HEPA filters.
Cleanroom ceilings are drop ceilings constructed of acoustical panels suspended on a tightly fitted grid and are only available in white. They can be high or low depending on the requirements of the room. The snug fit of the tiles prevents dust, moisture, or contaminants from entering the room.
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.
When producing a cleanroom ceiling, manufacturers use a large sheet of raw material that is cut into uniform shapes and sizes. Sealing material is added last before the tiles are shipped to installers. The cutting and shaping process guarantees that the tiles will fit snugly together.
There are several types and sizes of clean room ceiling tiles, which can be made of vinyl coated gypsum or mineral fiber. They have to be washable and resistant to soil, chemicals, solvents, rust, and corrosion. When properly cleaned and washed, ceiling tiles are water repellent and resistant to being scratched.
Gypsum ceiling tiles have a thickness of a half inch while mineral fiber tiles can be as thick as ⅝ of an inch. Tiles made of gypsum have a white vinyl finish that is durable, stain resistant, and easily cleaned. Additionally, ceiling tiles are light reflective and noise suppressing, which are critical features for special applications.
A necessary feature of clean room ceiling tiles is that they do not particulate into the clean room, which is prevented by the vinyl coating. Although vinyl is a common form of coating for ceiling tiles, other forms of coatings include aluminum, polycarbonate, stainless steel, and fiberglass reinforced plastic (FRP). Vinyl coated ceiling tiles have a sealed back and edges for use in ISO 5 (Class 100) clean rooms and meet USDA and FSIS standards for use in food processing clean rooms.
Every type of clean room has ceiling tiles regardless of their use and configuration. Washable, scrubbable soil resistant ceiling tiles are made for all forms of materials for industrial use from food processing to chemical laboratory experiments. They are securely placed in a clean room grid system as a means for protecting against contamination. Regardless of the material from which they are made, clean room ceiling tiles are engineered to fit the class of the clean room and its processes.
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 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 standards and regulations that Class 100 clean rooms must adhere to, the types of materials from which they are manufactured are limited. As a result, the panel or wall materials in Class 100 clean rooms are often made of materials including white acrylic, steel or stainless steel, aluminum or polycarbonate. In addition to regulating the materials that the clean rooms are manufactured from, the materials entering the clean rooms are also regulated.
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.
Some of the primary applications that Class 1,000 clean rooms are used for include inspection, patterning and integration tools like non-contract profilometry, flip-chip integration, thin-film deposition and laser micromachining. As a result of these diverse applications, Class 1,000 clean rooms are utilized in industries including pharmaceutical, scientific research, medical, electronics, semiconductor, food processing and industrial manufacturing.
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.
The primary function of clean rooms is to continuously filter air so that tiny particles in the air do not damage highly sensitive technologies, and in Class 10,000, the air changes 40-60 times an hour. However, this class is not particularly strict when it comes to limitations and rules regarding cleaning, moving around and clothing, but there are still special procedures for each of these activities that must be followed in order to prevent contamination.
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.
Below is a short list of some of the equipment that can be found in a cleanroom:
Every aspect of the occupants of a clean room has to be thoroughly cleaned prior to entering a clean room. The most difficult factor of clean room maintenance is keeping contaminants on personnel from polluting the environment. One of the biggest dangers is the types of materials that are collected on shoes. In extreme cases, personnel are not allowed to wear their shoes in the clean room and must put on special shoes in a cloaking room.
Automatic shoe cleaners are designed to remove large pieces of material that are attached to the bottom and sides of shoes. The cleaning process is very simple. Employees place their feet into a box like vacuum that sucks loose material off their shoes and sends it to a disposable collection bag. Although there are various other forms of shoe cleaning methods, automatic shoe cleaners are the most effective since they clean the whole shoe and 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.
The function of a pass through is to limit the amount of traffic that enters a clean room. Their purpose is to control and reduce the number of potential contaminants that may enter the room and provide a sealed structured opening for providing documentation, tools, and other materials for clean room operation.
The personnel of a clean room have been trained in the protocols and standards of a clean room as part of their job. In the case of every clean room, there are instances when untrained personnel may require access for a variety of purposes. Pass throughs make it possible for those people to give information to trained personnel without having to enter the clean room. In many ways, a pass through is a convenience that improves the efficiency of clean room operations.
Pass throughs take several forms with some mounted in the middle of a wall while others are built to allow carts to enter the room. The design of a pass through is dependent on the ISO rating of a clean room and the types of operations that are performed in the clean room. Pass throughs can have showers, HEPA filters, and UV sanitizing modules. They are an ideal addition to a clean room as a method for saving space while providing easy access.
There are a variety of names for pass throughs that include doors, windows, and chambers. They are an airlock chamber for efficiently transferring materials and parts from a clean room. Pass throughs reduce contamination between rooms and minimize clean room traffic.
Clean rooms are the most hygienic controlled environments in manufacturing with the purpose of providing a safe microbial free workspace for completing technical and biochemical work. Regardless of their high standards, there are certain aspects of a clean room that requires an extra level of protection. Such conditions necessitate the use of advanced environmental control, which comes in the form of containment hoods.
As with several factors of a clean room, containment hoods come in different shapes and designs to meet specific needs. Laminar flow hoods are the most common form and come as vertical flow hoods and horizontal flow hoods. They are used where vapors, solvents, chemicals and fine powders are present. Other forms of containment hoods include biological safety hoods, fume hoods, solvent hoods, and wet processing fume hoods. Containment hoods are an ideal addition to a clean room as a means of completing individual technical tasks and a next level of personnel protection.
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 are used in clean rooms to count the size and number of particles in the air of the clean room. They are capable of identifying particles as small as 0.1 micron (µ) up to ones larger than 5 µ. The size and count of particles in a clean room determine the clean room’s classification. Certification requirements stipulate that particles have to be below an acceptable limit and at a specified volume. Additionally, the size and number of particles determines the extent to which HEPA filters will be needed.
Light scattering is used to detect the size of particles using a laser sensor block, which contains a laser diode, sample inlet and exhaust, volume view, sensor cavity, sensor optics, and photodetector. The various elements of a particle counter moves air through the sensor block at which time the size of particles is recorded using light scattering technology.
A pump in the particle counter creates a vacuum that pulls a sampling of air into the inlet of the particle counter and over the laser diode. As the air passes through the inlet, it is compressed in order to get the most accurate particle reading. Air passing through the inlet reflects the light, which causes the light to scatter. Larger particles reflect more light. The energy from the deflected light is converted by the photodetector to quantify the size of the particles.
Airborne particle counters are a crucial part for monitoring, classifying, and diagnosing the source of contaminants in a clean room. There are two varieties of particle counters – condensation and optical. Condensation counters measure ultrafine particles that are not recorded by optical counters. Light scattering or optical particle counters are the most common type. They measure the number of particles that pass through a light.
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.
The use of stainless steel in the construction of desiccator cabinets is due to stainless steel’s durability and longevity, which is a necessity for desiccator cabinet integrity. Additionally, stainless steel can withstand the pressure created by the sealed compartments of the cabinet and is used for the separators for the individual sections.
The key to the success of a desiccator cabinet is its tight seal, which is necessary to preserve the contents.Desiccator cabinets can be made of welded stainless steel or quarter inch thick tightly sealed clear acrylic, a non outgassing material. Acrylic desiccator cabinets allow for easy observation and monitoring of the contents. Doors of desiccator cabinets have a spring loaded latch with a gasket that forms an airtight even seal.
A necessary feature of desiccator cabinets is protection against the effects of electrostatic discharge, which can damage the contents. Many of the tools and equipment in a clean room are sensitive to electrical interference that can be harmful to their function. Desiccator cabinets feature an electrostatic decay rate of 0.05 seconds per Federal Test Standard 1001C with a surface sensitivity of 106 to 108 Ohms (Ω) per square.
Clean room air showers are a method used to remove particulate matter from workers prior to their entering a clean room. They are self contained units with an air circulation system and are placed at the entrance to a clean room. Since people are the main source of contaminants that enter a clean room, the use of clean room air showers efficiently, quickly, and effortlessly removes particulate matter from personnel prior to their entry into a clean room.
The operation of an air shower is much like that of a car wash and involves the use of multiple steps as part of the decontamination process. When the door to the shower opens, a sensor activates an interlock magnet that locks the shower and clean room. Nozzles blow a high velocity stream of HEPA filtered air at the worker. The velocity of the air produces a scrubbing effect that removes particulate matter from the worker’s garments. The cleaning process takes four to eight seconds, which is followed by two to four seconds to remove contaminants from the shower. Once the cleaning cycle ends, an indicator light is activated, and the clean room door opens.
Clean room air showers are customized to fit the needs of the industry for which they are used and the number of personnel that use them. With the 90o design, personnel enter on one side and exit to the right or left of the shower. This type of design allows for the placement of nozzles on opposing walls, which is unlike the straight through design. Other designs can have double or triple doors and include parts cleaning, conveyors, pallets, and continuous operation.
Environmental monitoring systems provide real time readings of particle contamination with alarms and feedback. The readings from environmental monitoring systems make it possible to respond quickly to any form of contamination. They combine a system of counters, sensors, and software that constantly streams data about the conditions of the environment of a clean room.
The design of environmental monitoring systems supply data as graphs and in easy to understand formats. The instantaneous nature of the data makes it possible to immediately respond to a contamination event and prevent its spreading. Systems can be easily integrated into any form of clean room and includes an assessment regarding the strategic placement of sensors and the types of sensors that are required.
An environmental monitoring system ensures that air pressure, temperature, humidity, and particle counts are at the required level. The collected data is stored for years and can be used to substantiate the compliance of a clean room with ISO standards.
There are certain critical areas that have to be monitored to ensure a clean room lives up to its classification. An environmental monitoring system is constantly and continuously checking personnel for contaminants since they are the main source of particulate matter. After personnel, the system checks floors, walls, ceilings, and equipment to ensure that they have been properly cleaned. The final aspect of the monitoring system is the content of the air with samples being passed over a media plate to be incubated to reveal organisms and the number of particles per cubic feet or liter of air.
An aggressive environmental monitoring program provides critical data to prevent contamination and to help ensure compliance with ISO and federal standards. Their use helps keep a clean room operative to avoid delays in processes.
Natural airflow is in uneven patterns, which is turbulent and generates eddies and vortices. Since it is unrestricted, it gathers particles and deposits them on workspaces and surfaces. Laminar airflow creates a consistent airflow pattern that eliminates the effects of natural airflow. Air is sucked into a set of filters that cleans, purifies, and decontaminates the air before releasing it into the clean room. Laminar airflow provides clean air for clean rooms and helps meet clean room requirements.
The key to laminar airflow is its filtration system that consists of a series of pre-filters designed to remove large particles that are visible to the eye. The pre-filters are followed by HEPA filters that remove 99.99% of particles as small as 3 microns (µ). Once the air is filtered, it is released into the clean room, contaminate free, to assist in the production of sensitive technical products.
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.
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.
An important consideration when constructing a cleanroom is the avoidance of potential electrostatic discharge (ESD), which can damage or contaminate materials. Floors and surfaces are designed to prevent ESD’s by creating a non-turbo electric environment.
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 maintained at a static pressure higher than atmospheric pressure to prevent wind. The exception to the rule is when a cleanroom is being used for hazardous materials and must have a negative air pressure to keep it sealed and to avoid contamination from escaping.
As with all of the elements in a cleanroom, temperature and humidity must be constant to provide stable conditions for materials and instruments. Since humidity can damage products and equipment with corrosion or condensation, humidity has to be closely monitored and controlled. Control of the humidity can also assist in eliminating static electricity.
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, similar to soft wall modular units, are movable atmospheric and climate control enclosures for conducting research or fabrication. They can easily be assembled or disassembled on site without assistance. The growing need for movable and flexible cleanrooms has created increased demand for them.
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 are an alternative to modular clean rooms. They have a metal frame, referred to as sticks, with gypsum covered wallboard. Stick built clean rooms are considered to be an affordable simple form of clean room. Their flexibility makes it possible to shape, form, and fit them into any workspace. Construction entails a customized floor plan, installation of walls and ceilings, a high efficiency HVAC system, and various other components to meet the needs of the use of the clean room.
The types of ceilings for stick built clean rooms can vary from a ceiling grid system to a hard ceiling made of gypsum wall board. The walls and ceiling of stick built clean rooms are coated with epoxy or PVC for extra protection. The wide use of stick built clean rooms is due to their flexibility. When a business is expanding and redesigning, a stick built clean room can be constructed to fit into any available space.
As with all forms of clean rooms, there is a downside to stick built clean rooms. The most important of which is their durability. Although they are less expensive to construct, their low cost is balanced by their short useful life. In addition, stick built clean rooms require regular maintenance and upkeep, which further diminishes their lower cost.
A standard clean room refers to an environment that has been created to protect against the effects of particulate matter that can adversely affect the quality of a product or process. There are many factors that determine the type of standard clean room, which are defined by its ISO classification. Standard clean rooms are widely used in industrial operations that involve the manufacture of semiconductors, pharmaceuticals, biotech materials, and medical instruments and devices.
When discussing a standard clean room, it has to be understood that clean rooms are constructed and designed to fit the conditions under which they are used, since every type of clean room is adapted to fit specific criteria. In essence, it can be said that there is a standard clean room for microelectronics and one for pharmaceuticals. The type of product, regulatory standards, and available space are factors that determine which clean room fits the needs of a process or operation.
The basic interpretation of a clean room is a space that has been adjusted and configured to reduce the size and number of particles in its atmosphere to limit and control contaminants. Additionally, measures are in place to control the room’s temperature, humidity, and pressure with the key component of a clean room being the use of HEPA filters. All of the air that enters a specially designed clean room is filtered through a series of filters to achieve a specific level of cleanliness.
A further definition of a clean room is in relation to the personnel that use the room and the restrictions placed on them regarding their attire. As a clean room qualifies for a stricter ISO rating, its personnel have to take more measures to prevent their influence on the quality of air in a clean room. These requirements are directed at the type of apparel that is permitted in the room, which can vary from a hair net, mask, gloves, and lab coat to a complete and total covering referred to as a bunny suit.
The main factor that has to be kept in mind when approaching or purchasing a clean room is that it is a controlled space that has significant requirements that cannot and should not be breached. In most cases, the qualifications and standards for a standard clean room are in place to protect personnel and the integrity of the products they handle. Workers in a clean room are trained and advised as to the conditions under which they work. They are aware of the requirements and are admonished to uphold those requirements.
The term turbulently ventilated clean room refers to a clean room with non-unidirectional airflow where air in the clean room is mixed with filtered air to remove any lingering contaminates in the room. Turbulent airflow systems use complex methods for removing particulate matter. As with other clean rooms, turbulently ventilated clean rooms use a laminar filter system along with random, non-specific velocity filters. The pattern of turbulent airflow makes it difficult to separate particle filled air from the rest of the air. Non-unidirectional airflow systems take advantage of the random movement to send the particles through a complex system of filters.
With a turbulently ventilated clean room, air moves in all directions, and air quality is maintained by directing and circulating the air toward filters that are located in one place in the clean room or spread around the clean room. Aside from the negative connotation of turbulent and non-unidirectional, the airflow in a turbulently ventilated clean room is planned but includes several disparate and turbulent paths around tools, booths, objects, and equipment. The air is constantly moving as it passes through the filters.
The airflow of a turbulently ventilated clean room has the shape of a vortex as air entering the room mixes with the air in the room. The clean air dilutes the particle concentration in the room, which makes it easier for the particles to be removed by HEPA filters. The quality of the air in the room is maintained by the constant movement of the air through the filters to keep the particulate count and size within the acceptable range.
Unidirectional clean rooms are the most common type of clean room where airflow is in one direction, horizontally or vertically. The design of unidirectional clean rooms makes it possible for the clean room to receive an ISO classification of ISO 5 or lower. With a unidirectional clean room, filtered air enters the room at the top and sweeps down removing contaminants, which it carries out through vents in the bottom or sides of the room. The velocity of the exchange rate is between 0.3 meters per second up to 0.5 meters per second.
In a unidirectional clean room, the flow of air is directed by laminar air flow hoods. Additionally, the architecture of the room is configured to remove the possibility of turbulence, which would interfere with the unidirectionality of the airflow. The use of unidirectional clean rooms ensures that only clean filtered air passes into the clean room. The unidirectional flow of the air removes any particles that may be on personnel or equipment.
The circulation of air in a unidirectional clean room ensures that air moves at a steady velocity in parallel streamlines. Particulate matter is not allowed to be kicked back into the room. Air flows in a straight, unblocked path directed by laminar flow hoods. Unidirectional clean room airflow is the most efficient method for removing contaminants due to the uniformity of the airflow and the lack of turbulence.
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 many applications that do not require the advanced control features, this trade-off makes perfect sense and is a great cost saving option. On the other hand, it is important to keep in mind that used clean rooms may not have the features you require and may exhibit other issues or problems that come along with prolonged usage.
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.
FS209E contains six classes, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard (see chart below). The "cleanest" cleanroom in FS209E is referred to as Class 1; the "dirtiest" cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1 and the "dirtiest" a class 9. ISO class 3 is approximately equal to FS209E class 1, while ISO class 8 approximately equals FS209E class 100,000.
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.
The walls of soft wall clean rooms can be made from fabric pulled taut by a frame, or translucent plastic strips that hang from a ceiling or other overhead fixture. In addition, they are not stationary once installed. They are much more portable than hard wall clean rooms, which are usually permanently in one place once installed. Some varieties of soft wall clean rooms come in a modular design for easier and quicker disassembly and reassembly.
Everything that enters a cleanroom must meet the ISO standards for the room, which includes bottles, gloves, wipes, bags, swabs, and a wide assortment of things that most of us take for granted. Even documents and manuals used for reference have to meet the requirements before being used.
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.
Cleanroom design is a specialized process that requires the consideration of a variety of factors. Every cleanroom is unique and produced to specifically meet the needs of the company that uses it. The first and most obvious consideration is the budget, which can be difficult and complicated depending on how hygienic the conditions need to be.
Cleanrooms are classified according to the cleanliness and particle count of the air inside them. They are classified according to their compliance with the quantity and size of particulates. ISO 14644-1 summarizes the classification of air cleanliness for cleanrooms and specifies the required particulate airborne particulate count. Cleanrooms are tested and checked on a regular basis to ensure they are able to maintain their classification.
Over the last few years, ISO 14644-1 has undergone various revisions to simplify and streamline the classification process. Also, with the constant technological advancements in production methods, revisions have had to be made to account for these changes and make classification more applicable to present day conditions.
The three forms of cleanroom walls are soft, hard, and rigid each of which comes at a different price. The least expensive of cleanrooms and walls is soft walls that are made from sturdy, stiff, and durable polymers such as polyvinyl chloride (PVC).
Rigid walls are a compromise between hard and soft walls. They are made of various types of clear hard plastics that can be easily removed like soft walls but have the same sturdiness as hard walls.
Insulated hard walls are the best type of walls that provide a secure and impenetrable surface to protect cleanroom operations. Hard walls can meet the requirements of any level of classification. Although they are solid and hard, they can provide the same type of flexibility found in softwall and rigid wall cleanrooms. A popular version of hardwall cleanrooms are prefabricated ones.
Temperature control is an essential and critical part of a cleanroom since it determines the nature and type of work that can be completed in a cleanroom. Included in temperature control is control of the humidity, which can influence conditions that create corrosion and condensation on work surfaces and instruments. An additional consideration in regard to temperature is the comfort of workers, which has to be balanced and pleasant for optimal performance.
Flooring is the aspect of a cleanroom that supports and unifies all of the various parts of a cleanroom. There are several varieties of flooring that can be used that vary between vinyl tiles and rubber mats to perforated grates and panels. Flooring that is made of perforated grates or metal panels are raised by supports off the foundation to promote better airflow. Raised flooring is more expensive but is recommended for ISO 1 to ISO 6 cleanrooms.
Airlocks are necessary at the highest levels of cleanrooms as extra protection and removal of atmospheric contaminants that workers may carry on their clothing. They consist of two or more doors that cannot be open at the same time. Airlocks can include air showers that use gusts of air to remove contaminants from workers as they enter a cleanroom. The normal ISO level for airlocks are ISO 2 and ISO 3. High level cleanrooms have two or more airlocks for contaminate control.
clean room World is a supplier of all products having to do with the construction and designing of clean rooms as well as clothing, equipment, filters, ventilation systems, and other necessary components. They specialize in modular, portable, and softwall clean rooms with ISO classifications of ISO 4 (Class 10) up to ISO 8 (Class 100,000). The company’s modular clean rooms are used by the semiconductor industry, aerospace, medical device manufacturing, and pharmaceuticals. Cleanroom World has whatever is needed for the construction, development, and required materials to create a contaminant free environment.
clean rooms International has a complete listing of clean room solutions including workstations, components, and air handling equipment. The company provides testing, accreditation, certification, and counseling services to assist customers to develop the perfect solution. clean rooms International prides itself on developing innovative solutions for unusual and unique problems. In its over 40 years of operation, the company has helped several industries including aerospace and animal husbandry. The wide scope of clean rooms International knows no boundaries and is capable of attacking and resolving any problem.
CleanZone is a clean room supplier and manufacturer that designs, builds and installs all forms of clean rooms from ISO 5 (Class 100) up to ISO 8 (Class 100,000). The company covers every aspect of clean room installation regardless of the type of clean room using high quality wall materials, panels, ceiling grids, doors, pass throughs, and windows. CleanZone supplies clean rooms to universities, medical marijuana facilities, and the electronics industry. The company prides itself on its devotion to providing full service at costs that fit a customer’s budget.
American clean room Systems specializes in clean rooms for the pharmaceutical and medical industries as well as clean rooms for other specialized industries. The company is a full service clean room manufacturer with engineering and design services that include flooring, monitoring systems, and laminar equipment. The emphasis of American clean room Systems is to assist customers in rapidly installing and producing certified clean rooms that meet all specifications and standards. The company adheres to the requirements of national and international standards and provides detailed guides to assist in increasing customer knowledge. American clean room Systems ensures customers that the company will install and set up a clean room with minimal disturbance of customer operations.
Allied clean rooms is a modular clean room manufacturer that provides custom designed and constructed clean rooms to meet the special needs of customers. The company adheres to the Current Good Manufacturing Practices guidelines that have been established for the manufacture of equipment for pharmaceutical packaging, producers of medical instruments, and equipment for food production. Allied clean rooms installs clean rooms with classifications of ISO 4, 5, 6, 7, and ISO 8. Aside from its offering of modular clean rooms, Allied clean rooms also has a selection of freestanding softwall clean rooms with steel or aluminum frames.
As technological and sensitive equipment continue to be produced and introduced, clean rooms are steadily becoming a necessary part of several industries. Workspaces that are free of dust, microbes, and particulate matter are an essential and necessary part of electronics production, medical instrument manufacturing, and the formulation of various forms of medications. The thrust of modern manufacturing has been toward producing stronger and more durable products free of potential hazards and defects, which are better produced in minutely controlled environments.
Cannabis has all of the stipulations that are related to the precautions of the pharmaceutical industry. It is ingested orally or smoked and is used for medical purposes. In accordance with that definition, cannabis clean rooms have to adhere to the highest sanitary standards for the protection of the public. The legalization of the use of cannabis has placed it under the guidelines established by the FDA and EU GMP, which delineate how medicines are to be properly handled.
Although there are similarities between pharmaceutical clean rooms and cannabis ones, cannabis clean rooms have special conditions due to the types of materials required to produce cannabis. Pharmaceutical clean rooms have to deal with powders, chemicals, and airborne contaminants. Since cannabis comes from a plant, cannabis clean rooms have to deal with factors associated with growing plants, such as mites, insects, cross pollination, and microbial contamination associated with agriculture.
In addition to the difficulties associated with plant contaminants, cannabis clean rooms have to deal with the difficulties of bucking and drying, which require close monitoring and control of temperature and humidity. The unique nature of cannabis production requires clean rooms that are exceptionally sturdy and capable of withstanding the harsh conditions of cannabis production. In the majority of cases, cannabis clean rooms have an ISO 5 up to ISO 8 classification for safe handling of cannabis products.
The different materials associated with the manufacture and production of vaccines have to be handled and produced in a clean room. How vaccines are produced varies with some companies handling the process from start to finish while other companies have other companies produce the components of a vaccine. In addition, the facility where a vaccine is produced will be changed in accordance with the type of vaccine. Viral vaccine manufacturers have different facilities compared to plant based or RNA vaccine producers.
An interesting and critical aspect of vaccine production is the array of different types of components used to produce vaccines. Product production for vaccines use highly diverse components that range from live organisms up to inert proteins, which make a significant impact on the design and certification of a vaccine clean room. Every stage of vaccine manufacturing demands the use of a clean room. As with all forms of clean rooms, vaccine clean rooms require precision control of temperatures, humidity, airflow, air pressure, and include safety measures for the protection of workers.
Clean rooms are the key factor in the production of vaccines. Oversight and regulatory agencies meticulously observe the procedures used to produce a vaccine to ensure its viability and to protect the public. Since every step of the manufacture of a vaccine occurs in a clean room, clean room integrity is held to the highest standards.
The pharmaceutical industry deals with a wide range of chemicals, compounds, and powders that are lethal and dangerous. Included in this wide spectrum of components are hazardous drugs, which have several risks in regard to their production, storage, and handling.
Clean rooms for hazardous drugs have to be isolated and disconnected from the facility where they are located to prevent the spread of contaminants. All of the various aspects of a clean room are included in a hazardous pharmaceuticals clean room but with extra precautions for the safety and protection of personnel. Since the materials being produced are so dangerous, they have to be stored in the clean room and kept under the most secure requirements. This necessitates significant enhancements for hazardous pharmaceutical clean rooms to a higher level and highly restrictive conditions and requirements.
The definition of a hazardous drug has been established by the National Institute for Occupational Safety and Health (NIOSH), which states that a drug is hazardous if it is carcinogenicity, teratogenicity, has reproductive toxicity, organ toxicity, genotoxicity, or structures that mimic existing hazardous drugs. USP 800 stipulates the requirements for personnel who handle hazardous drugs, and procedures for deactivating, decontaminating, and cleaning of hazardous pharmaceutical clean rooms.
The main concern regarding hazardous drugs is the personnel that have to handle them. The greatest danger comes from a drug coming in contact with the skin of a worker. To that end, USP 800 clearly outlines the types of clothing workers should wear and must affirm that the clothing has been tested for its integrity.
Clean rooms used in food production, as with any clean room, are designed to control airborne contaminants and pathogens. The purpose of food processing clean rooms goes beyond controlling the contamination of a process or product. It includes the stability and life of the product since any contamination in food can shorten its useful life. With the continued orientation of consumers toward foods with natural ingredients, the control of the environment where food is prepared becomes more important.
The use of clean rooms in food production is difficult due to the high production rate for the industry and the number of times food products have to be handled before being packaged. These factors require a higher degree of monitoring and control and specialized equipment to maintain a compliant clean room environment. Regardless of the challenges of clean rooms for food processing, the food industry requires the use of clean rooms to extend the shelf life of its products.
Safety, shelf life, and quality make clean rooms a constructive addition to food processing. They are as essential to the food industry as oxygen reduction, ingredients, formulations, and proper and timely distribution. Of the many types of clean rooms used for food processing, softwall clean rooms are the most common due to their low cost, easy installation, and flexibility. Rigidwall clean rooms are also popular as a compromise between hardwall and softwall clean rooms. Hardwall clean rooms are used by food processing but tend to be more expensive and unable to adapt to changes in food production.
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