This article takes an in depth look at Cleanroom Products.
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Cleanroom products are meticulously designed and engineered to avert the contamination and pollution of extremely sensitive cleanroom environments. To achieve a specific classification level, a cleanroom must be cleaned, built, and sanitized according to a comprehensive set of standards and criteria. A crucial aspect of this process for manufacturers or companies to attain the ideal conditions is using the appropriate cleaners and materials essential for cleanroom production.
Each tool, equipment piece, and material used in a cleanroom needs to meet stringent specifications to qualify as a cleanroom product. Manufacturers strive to guarantee that the products they offer fully comply with the requirements of the International Organization for Standardization (ISO) and the United States Federal Standards Act 209E.
The effectiveness of a cleanroom is dependent on the types of equipment used to complete assemblies, testing, and research. As with all of the materials used in a cleanroom, its equipment must meet the rigorous standards for cleanrooms to maintain its ISO classification.
Cleanrooms require the highest degree of sanitization; these high standards apply to every item that enters the room, from a pad of paper to large, hooded air circulation systems. Much like any work environment, cleanrooms have necessary work materials. The uniqueness of cleanroom work tools is their extraordinary cleanliness.
Fume hoods, known as fume chambers and cupboards, are venting systems that capture and contain toxic fumes, particulate matter, and vapors. There are several types of fume hoods, including PVC ducted, carbon filter recirculating, laminar air flow, biosafety cabinets, clean benches, and snorkel exhausts.
The primary functions of fume hoods are to protect the user, the product, and the environment. The use of cleanroom fume hoods is essential in cleanroom environments where noxious chemicals and hazardous materials are tested and researched.
A specialized type of fume hood is a laminar flow hood that separates the air flow into layers to cleanse it of contaminants. Much like other fume hoods, a laminar flow hood is an enclosed work space with the added feature of protecting samples from airborne contaminants to create a dust free environment to minimize contaminants.
A laminar flow hood has a filter pad, fan, and HEPA filter. The fan pulls the ambient air into the HEPA filtration system from which it is passed to the work space. The two types of laminar flow hoods are horizontal and vertical air flow systems with the horizontal flow system having a back to front flow and the vertical system having a downward flow.
Vertical air flow laminar hoods direct the flow downward and reinforces the effects of gravity by sweeping particles down and out of the enclosure. They are used when floor space is at a premium and eliminate contaminants from floating around inside the enclosure.
With a horizontal laminar flow hood, air flows through a HEPA filter and is forced across the work surface from back to front. They have a deeper style to make room for the rear mounted filter and fan unit and require additional clearance.
Another specialized fume hood form is a biosafety cabinet, which is a specially designed enclosure for the handling of contaminated materials or pathogens that necessitate observation in a defined biologically safe space. Biosafety cabinets use vertical laminar air flow in order to form a barrier against contaminants. There are three classes of biosafety cabinets, Classes I,II, and III, with class three being the most stringent and capable of handling highly contagious microbiological agents.
The purpose of a vacuum chamber is to create a pressure and air free environment for the purpose of testing components. It is a rigid and well controlled environment that comes in several different configurations to meet the needs for testing specific materials.
Vacuum chambers can be used for batch testing and processing applications that necessitate a sustained and precision regulated level of vacuum. Depending on the testing needs, vacuum chambers can be made of acrylic, aluminum, or stainless steel. The materials of the chamber determine the level of testing it can perform.
A desiccator is a laboratory instrument. It is a round closed container made of exceptionally durable glass used for storage of items that require a moisture free environment. At the bottom of the desiccator is a perforated plate that is located above the drying agent, which can be anhydrous calcium chloride, calcium sulphate, or silica.
The four types of desiccators are standard, vacuum, automatic, and gas purge. Standard models are used as desiccator cartridges and are economical. Vacuum types use a pump to remove moisture. Automatic models operate continuously using a fan and heater. Gas purge models use nitrogen and argon as atmospheric drying agents.
A nitrogen generator performs a process called pressure swing adsorption and membrane technology, which is the extraction of nitrogen from the air followed by its compression. It provides a pure flow of nitrogen without the need for canisters. Nitrogen generators provide 99% pure nitrogen at medical grade levels to desiccator cabinets, gloveboxes, and vacuum chambers, to name a few applications.
A cleanroom pass thru is mounted on a wall of the cleanroom and allows the passage of products and materials through the opening. Pass thrus eliminate unnecessary traffic in the cleanroom and decrease the spread of potentially harmful contaminants. The type of pass thru for a cleanroom depends on the ISO classification of the cleanroom; there are pass thrus with heavy duty sealing locks and double door designs.
Cleanroom door swings can be single or double and are designed to maintain the particle free sterile environment. They provide exceptional security, provide protection against contamination, and are the first line of defense for the cleanroom‘s integrity. As every other component of a cleanroom, door swings are required to meet a set of cleanliness specifications.
More and more cleanrooms are beginning to use automatic door swings that allow for greater control of the door, such as the speed at which the door opens and closes as well as obstruction sensing devices. Depending on the ISO classification of the cleanroom, it may have a double swing door entry with a pass thru.
Laboratory ovens have a uniform construction consisting of an enclosed insulated space with a heating element. There are a wide variety of designs with specialized types for thermal processing and types for curing and testing. Laboratory ovens are divided according to their heating method.
The types of lab ovens include forced air, gravity convection, and mechanical. Of the three types, mechanical ovens are most commonly used. Forced air ovens use mounted blowers that circulate high velocity air. The blowers protect batches and enhance heat transmission. Gravity ovens do not have circulation fans or blowers. They pass heat through convection. Mechanical ovens have blowers or fans and have better temperature uniformity.
A cleanroom air shower serves as a gateway control between the outside environment and the uncontaminated cleanroom enclosure. It is installed as part of the entryway as a means of reducing the introduction of contaminant matter. Though all cleanroom personnel are required to wear proper apparel, there is still the potential of the introduction of lint, small fragments, or debris into the cleanroom. The air shower removes such potentially hazardous elements.
The cleanroom air shower is a self-contained chamber that has high velocity air flow and low pressure. When a person enters through one of the dual locking doors, a high velocity fan blows air over them. The air entering the chamber is HEPA filtered and air washes the occupant of particulate matter that moves to the low pressure side of the chamber.
Every aspect of a cleanroom has to comply with the set of standards set for its classification. Many of the things taken for granted in a normal laboratory or manufacturing setting are closely scrutinized to ensure they are acceptable and compliant. The floor, ceiling, walls, lights, and other structural features need to have the same sanitary and cleansed conditions.
The most stringent of the ISO classifications is ISO 1, which has a particulate matter size rating of less than 0.02 μm. The structure of a cleanroom is designed to regulate temperature, humidity, airflow, filtration, and pressure, which are all controlled by the configuration of the floor, walls, and ceiling as well as air handling units.
The air handling unit for a cleanroom is the means for controlling the temperature, level of humidity, and pressure in the room. For a cleanroom to comply with ISO standards, this aspect of the room must be highly efficient and accurate.
Air handling units are part of the HVAC system and are a high powered air processing device that controls air movement and conditioning. Within the air handling unit are HEPA filters capable of removing 99.9% of contaminants, toxins, and particulate matter.
The efficiency of the air handling unit enables the room to reach its μm rating.
An essential part of an air handling system is the fan filter unit, which is the system that removes particulate matter and ensures the room is uncontaminated. The structure of a FFU includes HEPA filters for removal of particulate matter of 0.3 μm or less. Also included are ultra-low particulate air (ULPA) filters that remove impurities that are 0.23 μm or larger and minimum efficiency reporting value (MERV) filters for removing particulate matter from 0.3 μm to 10 μm.
FFUs can be placed in the floor or ceiling depending on the design of the room. The size of the cleanroom determines the number of FFUs that are required to meet the rooms ISO rating. Many cleanroom fan filter units have a prefiltration system that removes large visible matter.
Cleanroom lighting fixtures are teardrop, recessed, surface mounted, and fit securely into the ceiling grid. The type of lighting fixture depends on the classification of the cleanroom. They are tightly sealed with a gel or gasket to maintain the integrity of the room and to ensure they are airtight.
The best type of lighting fixtures are light emitting diodes (LED) that produce even and consistent light without shadows. They are the most cost effective solution for cleanroom lighting and come with methods for controlling their brightness.
Cleanroom ceilings come in many forms and configurations. They are engineered to meet the ISO rating of the cleanroom. The two main types of cleanroom ceilings are self supporting ceiling grids and hanging ceiling grids. A self supporting ceiling has a perimeter with T shaped cross supports attached. To seal the room, the inserted panels are screwed to the T cross supports.
Hanging ceiling grids must be able to support the weight of air handling units, filtration systems, and lights. The gird for the ceiling hangs from the joists of the building and are made of heavy turnbuckles and steel rods. When selecting a hanging ceiling, it is important to determine in advance whether the ceiling will be walkable for maintenance and cleaning.
The flooring for a cleanroom does not receive the same consideration as the other structural components. As far down the list as the flooring may be, it has to receive the same examination as all of the other parts of the room.
When making the selection of flooring, it is important to evaluate the existing floor, how it will be cleaned, the room‘s ISO classification, compliance with good manufacturing practices (GMP), and the compatibility of the floor with the processes that will be performed in the room. In the majority of cases, cleanroom flooring is made of highly durable vinyl that has a smooth and even finish.
Raised floors are used to assist in laminar access from an HEPA filtered ceiling, which pushes air directly down from the ceiling. The surface of the floor consists of perforated panels to achieve maximum air volume and pressure.
Common types of wall used for cleanrooms are modular, which allows for a flexible structure. The walls are tightly sealed and firmly fitted in place. Panels are made from a wide selection of materials and are resistant to attracting contaminants and particulate matter. The structures of panels are available in sizes to fit the dimensions of any size cleanroom.
The main considerations when choosing cleanroom walls are the required cleanliness for the room, does static electricity need to be controlled, and what cleaning agents will be used to disinfect the walls. The advantages of cleanroom panels is the ease with which they can be installed and replaced when damaged.
As inconsequential as it may seem, cleanroom furniture is an important part of the successful operation of a cleanroom. Unlike the furniture in a typical office, cleanroom furniture has to meet the same strict standards as any equipment used in a cleanroom.
Included in cleanroom furniture are ergonomically designed chairs, tables, and workbenches. Many applications of a cleanroom require workers to be at a particular station for an extended period. Having the proper types of furnishings ensures the health of workers and prevents errors.
Cleanroom tables are multifunctioning parts of a cleanroom that can hold equipment and serve as a data collecting space or a desk. They are normally used for lighter work and are made of sturdy powder coated steel. They are ergonomically designed and may come with hydraulic or crank height adjustment mechanisms.
The sensitivity and function of cleanroom tables varies in accordance with the cleanroom ISO classification. In more stringent settings, cleanroom tables may have antiseptic seals on the surfaces of the table, top and bottom, and the legs.
Cleanroom chairs are divided by cleanroom classifications ISO 1 to 10 with ISO 5 and 6 being the most common. They are made of vinyl, various fabrics, urethane, and ESD fabrics and are designed for harsh and hazardous environments. Typically, cleanroom chairs have wheels or chrome glides for ease of movement and efficiency.
Wet benches are used for the testing of corrosive and hazardous chemicals. They have a laminar flow canopy with each bench designed to handle one specific substance. When a wet bench is classified, it is labeled as an acid bench or solvent bench or is given a name that identifies the material it is designed to handle.
Acid benches are specially designed using polypropylene tops and fittings. Solvent benches are made with stainless steel liners, fittings, and surfaces. Depending on the use of a wet bench, it may have water and nitrogen taps, wash tanks, dump rinsers, aspirators for diluting and cleaning acids, quartz tanks, hot plates, ultrasonic tanks, and sinks, to name a few additions.
Two key factors in cleanroom use are efficiency and mobility. Cleanroom work requires precision, care, and accuracy, but it has to be completed in a specified amount of time. Each element of a cleanroom is planned down to the smallest detail for the sake of safety and the prevention of errors. Cleanroom carts provide a smooth and efficient method for moving test items, tools, and equipment.
Cleanroom carts are made of stainless steel and have locking casters for maneuverability. They are compact and allow for easy access to their contents. As with all components of a cleanroom, they are designed to be dust and contaminant free with solid and sturdy surfaces.
There are several levels of cleanrooms with each one having a different set of requirements regarding cleanliness and hygiene. The standards begin with the construction of the room and its air supply; this is followed by the allowable pieces of equipment and products.
As with the classification of the structure of a cleanroom, its products must also adhere to requirements; the requirements they adhere to determine the level of the cleanroom and where the products can be used. The products for a cleanroom can be divided into categories: sanitary cleaners, room furniture, lab equipment, monitoring devices, apparel, and storage units.
Cleanrooms, with high efficiency particulate air (HEPA) filters and exceptional quality air conditioning systems, are designed to prevent contamination and the presence of pollutants. Regardless of all the technological methods used to limit contaminants in a cleanroom, they still require regular cleaning.
Unlike other cleaning processes, the cleaning of a cleanroom goes far beyond a normal job of cleaning since they must be antiseptically cleaned to retain their cleanroom classification. A superficial cleaning involves the removal of dirt, debris, and surface particles; this can be performed using a detergent, solvent, or soap.
The next level of cleaning for a cleanroom involves complete disinfection that removes and kills contaminants. This aspect of cleaning for a cleanroom is the most crucial and critical.
The two forms of disinfectants are oxidized and non-oxidized. Of the two, oxidized disinfectants are the most dangerous and must be used with caution since they can interact negatively with other chemicals. Non-oxidized disinfectants are also powerful cleaners and normally contain alcohols or ammonium compounds.
There are a wide variety of wipes that are appropriate for use in cleanrooms. They include microfiber wipes, saturated wipes, microelectronic wipes, and wipes for cleaning stencils. Aside from the different fibers and sizes of wipes, the different types of wipes contain specific chemicals for specific applications.
Cleanroom wipes can be categorized by the type of material used to make them. Most are made using microfibers that are designed to remove organic materials. They are made from split fibers, which are thinner, finer, and capable of catching all forms of substances and meet the qualification of being low lint.
Dry knitted wipes are used in Class 10 or ISO 4 and Class 100 or ISO 5 cleanrooms. They are made from polyester, will not tear, are non-abrasive, and exceptionally sterile.
Dry non-woven wipes come in several different varieties depending on how they are manufactured. Each version of dry non-woven wipes is designed to fit the requirements of a specific class of cleanroom.
Pre-saturated cleanroom wipes have the cleaning substance in the fabric of the wipe and are an exceptionally safe and efficient cleaning tool. The types of solutions include isopropyl alcohol (IPA), ethanol, and hydrogen peroxide. The materials used to make pre-saturated wipes includes polyester knife cut, polyester sealed edge, poly cellulose, and melt blown polypropylene.
Cleanroom mopping systems are a necessary part of retaining a cleanroom‘s ISO classification. They are designed to provide an economical, easy, and dependable process for cleaning a cleanroom without leaving residue or biomatter.
The two types of cleanroom mopping are disinfecting and wipe down. Each form requires a specialized and precisely designed mop head made of high quality fabrics that are easy to change. The main purpose of the mop head is to dislodge and remove biomaterials that could inhibit the effectiveness of the cleaning solvents. In the majority of cases, woven or double knit polyester provides the necessary strength without shedding.
Abrasive qualities, absorption, ease of use, and chemical factors are essential for an effective mopping system. The mop head must integrate positively with cleaning solvents since incompatibility can lead to damage to the mop head fabric.
A special group of cleanroom products are the USP 800 group. This special set of provisions covers the handling and management of hazardous and dangerous drugs in cleanroom and healthcare settings. The set of USP 800 standards were published in 2016, but it has yet to be fully implemented.
Cleanroom manufacturers and product suppliers have already begun developing materials and supplies to meet the requirements outlined in USP 800. Included in the USP 800 tools are mats and mops that are fabricated to meet the stipulations of ISO class 5 or Class 100. The cleanroom supply industry has been following USP 800 guidelines in hospitals and pharmaceutical applications with the understanding of the growing need for the use of the USP 800 guidelines.
Like most of the products for cleanrooms, cleanroom mats come in several styles, sizes, materials, designs, and configurations, with each type fabricated to perform a special function. Cleanroom mats are made to assist in maintaining the sterility and integrity of the cleanroom environment by protecting the floor and collecting dirt from footwear.
The different types of mats include sticky, carpeted, footbath, anti-fatigue, anti-microbial, and disposable.
Sticky cleanroom mats, also known as adhesive mats, are made from layers of polyethylene sheets that have a specially treated pressure sensitive adhesive on the upward exposed side of the mat. When workers enter the cleanroom walking over a sticky mat, it grabs dust and dirt on the soles of their shoes.
A footbath cleanroom mat has a disinfectant solution and rubber scrapers that remove contaminants from footwear. The mats are capable of holding one gallon of cleaning solution, which is typically a chlorine or quaternary solution. The mat immerses the treads and sides of the soles of footwear.
Anti-fatigue cleanroom mats are an ergonomic floor mat that is designed to relieve leg strain when it is necessary to stand on a hard surface for an extended period. This type of mat reduces fatigue that causes poor circulation. Operators are prevented from experiencing fatigue and kept comfortable.
Anti-microbial mats, also known as contamination control mats, have an antimicrobial agent that prevents the growth and spread of bacteria. The protective agent is a chemical configured to trap and destroy fungi and bacteria that may be carried into a cleanroom on the soles of workers‘ footwear. The antimicrobial compound is applied to the top and bottom of the mat as well as its fibers.
Cleanroom shoe cleaners are used to control contamination from dust and particles on shoes. They are motorized cleaners with brushes that clean all sides of shoes and footwear. Cleanroom shoe cleaners can clean shoes up to six inches wide and can be adjusted to clean smaller width shoes.
Attached to a cleanroom shoe cleaner is a vacuum system that draws the removed dust and particles into a dust bag with the dust filled air from the cleaner discharged through a HEPA filter. For the protection of users, cleanroom shoe cleaners have a slow starting torque that builds after shoes are placed in the cleaner.
For a cleanroom to retain its ISO classification, the workers in the room have to be attired in coverings that meet the stipulations of the classification. The basic requirements of cleanroom garments are that they be lint free and non-shedding.
Every class of cleanroom has a list of approved apparel to meet the level and standards of the cleanroom. The most restrictive requirements necessitate the wearing of goggles, bouffant hats, hoods, footwear coverings, face masks, and exceptionally sensitive hygienically clean gloves.
Types of cleanroom apparel include gowns, coveralls, frocks, coats, aprons, shirts, pants, shoes, footwear covers, sleeves, and hoods.
A material is considered to be sterile if it has had all loose particles, threads, fabric, and lint completely and entirely removed. Sterile garments are made from materials that block particles, contaminants, and non-hazardous splashing.
SMS is a nonwoven fabric that combines spun bond and melt blown. This type of material has exceptional durability and strength whether it is wet or dry and is highly resistant to fraying or unraveling. The melt blown portion is softer and pliable and adds a more pleasant texture to the material since spun bond fabrics tend to be stiff, rigid, and uncomfortable.
Any environment can produce ESDs. In a cleanroom, they can be damaging and negatively impact cleanroom processes. ESD fabrics prevent and protect against ESDs that are normally produced by clothing.
Microporous material is made of nonwoven, laminated, breathable microporous film, which is an excellent barrier against biological infective agents. Regardless of the lamination, the nonwoven side of the material has a soft feeling. The features of microporous materials are protection against liquid and blood penetration, a high moisture vapor transmission rate (MVTR), abrasion resistance, and an antistatic property.
Chemical resistant materials are capable of withstanding exposure to a wide range of chemicals such as bases, solvents, and acids. Each type of fabric is resistant to a certain and specific type of chemical. For example, nylon is resistant to acetone but can be damaged by water.
Included in chemical resistant materials are Arkema, Baden aniline and soda factory (BASF), Solvay, nylon, and polyvinylidene fluoride (PVDF) to name a few.
FR materials do not easily catch fire or melt when exposed to fire or some ignition source. The two types of FR materials are inherently flame resistant fabrics and those that have been chemically treated. Inherently flame resistant materials or fabrics have a chemical structure that makes them naturally resistant to fire. A chemically treated fabric has had a flame resistant chemical applied to the fabric.
For a fabric to be classified as flame resistant, it has to meet the stipulations of the American Society for Testing and Materials (ASTM) standard F1930, Standard Test Method for Evaluation of Flame Resistant Clothing for Protection Against Flash Fire Simulations Using an Instrumented Manikin. Any flame resistant fabric must be disposed of if it becomes damaged.
A biohazard resistant material is a variation of microporous film technology, and it protects against particles and non-hazardous liquids. To qualify as a biohazard material, the fabric must be able to protect against contaminants, plants, animals, and various byproducts. There are four levels of biohazards:
As with all cleanroom apparel, aprons are designed to prevent pollutants from contaminating the space. They are resistant to spills from acids, alkalis, and different types of chemicals. They have long sleeves with elastic cuffs to block splashes from striking the arms of the wearer.
The basic requirements of cleanroom bouffant caps are that they be lightweight, cool, and non-lint producing. In most cases, they are made of polypropylene and have a floss style elastic cover band. Bouffant caps are normally a one time disposal product that are immediately disposed of after use and come in materials that meet the class of the cleanroom in question.
Cleanroom suits or coveralls are considered in the determination of the materials that can be handled by technicians in a cleanroom. First, the type of material a suit is made of sets the limits to what the wearer can work with. One of the main differentiations between cleanroom suits is whether they can be used with biohazard or chemical.
Though biohazard and chemical are clear distinctions, suits are further divided by the severity of the materials, with some suits resembling equipment for space travel. In some cases, cleanroom suits are one use and disposable due to the types of materials being handled.
Biohazard suits are divided according to how dangerous the biomaterial is. They are ranked and categorized from basic resistance to suits capable of existing in a highly toxic environment for several hours. Biohazard materials are divided into four levels: A, B, C, and D. Level A is the most severe and level D is the least severe.
Level A biohazard suits are designed for spills and cleanups since they have air tanks to keep the user from breathing in disaster fumes. Cleanrooms don‘t normally require that level of protection. At the most severe, cleanrooms may have coveralls as pictured below with boots, a hood, gloves, and a mask.
Non-sterile coveralls are worn over everyday clothing to prevent the spread of lint from clothing and particles. They have the same function as biohazard coveralls without the stringent requirements. Included in non-sterile coveralls are a hood, footwear coverings, full body suit, and gloves.
Since the purpose of a non-sterile coverings is to control particulate matter and lint, coverings for the face are not necessary. Some styles of non-sterile coveralls do not include coverings for footwear, hands, and the head.
Chemical and virus suits are designed to deal with acids, chemicals, viruses, and bloodborne pathogens. They can be used as regular apparel for exceptional protection in cleanrooms that are handling acids and caustic chemicals or kept as emergency equipment. For extra protection, chemical and virus coveralls have taped seams to form an extra seal against leakage. Depending on the needs of the application, chemical and virus coveralls can be sterile or non-sterile.
Nomex® is an exceptionally strong material that was developed by the DuPont Corporation. When Nomex® is exposed to intense heat, its fibers thicken and carbonize by absorbing the heat energy. Due to this characteristic, Nomex® will not melt, drip, or combust. The molecular structure of Nomex® prevents electricity from flowing through it when it is exposed to arcing electrical currents.
Though Nomex® is a highly resilient and durable material, it is expensive and only necessary in unique and unusual conditions. It is available in all forms of cleanroom garments from frocks, hoods, and coveralls to gloves and foot coverings.
Tyvek® is another DuPont product that is designed for cleanrooms. The material of Tyvek® provides a barrier against particles, contaminants, and non-hazardous material splashes. It is a nonwoven and lightweight fabric that is produced using a flash spinning process. The serge seams do not have raw edges but include extra stitching for a strong, stress resistant seam.
Tyvek® cleanroom garments come in coveralls, frocks, lab coats, hoods, boot covers, and bouffant caps.
Cleanroom foot coverings are worn over shoes to prevent contamination of the environment by particulate matter. As with all forms of cleanroom fabrics, foot coverings are lint free and do not shed. They come as sterile and non-sterile booties and simple shoe coverings. The difficulty in shoe coverings is the wide variety of styles, types, and materials that are available.
The materials used to produce shoe coverings include Tyvek®, polypropylene, CPE plastics, latex, and polyethylene to name a few. The quality of the materials of foot coverings must meet the ISO classification of the cleanroom.
Masks are not a necessity for every cleanroom and are only required in medium to extremely strict conditions. The types of masks can vary between heavy duty types designed to filter the air to types that prevent the inhalation of fumes from cleanroom processes.
The varieties of cleanroom masks include ear loop, four tie, pouch, and visor. Ear loop masks are a standard type with two elastic bands that stretch over the ears. A four tie mask is a surgical style that ties in the back of the head. A pouch style mask is a non-sterile mask that has extra material around the mouth and nose to provide a larger breathing space. A visor mask comes with an attached shield at the top and can be four tie or ear loop.
Additional preventative measures for cleanroom masks are cleanroom mask dispensers. They hold masks in a sanitary container with a lid to prevent contaminants and dust particles from getting to them. Depending on the type and the requirements of the cleanroom, mask dispensers can be wall mounted or free standing. They are made of clear plastic and are single-use.
Cleanroom hoods are worn over the head to keep unclean matter from hair from contaminating the environment. Hoods come in several varieties, with those that cover the whole face with the exception of the eyes and others that fit under the chin and cover the sides and back of the head. The purpose of hoods is to be used in sterile cleanrooms that are rated at class ISO 4 and ISO 5.
The types of gloves used in a cleanroom vary according to how they are shipped and packaged. For high classification cleanrooms, gloves have to be individually packaged in a sterile plastic bag and free of powders or other packing materials. Packing of gloves in cardboard is not permitted since cardboard particles can be introduced to the cleanroom.
Typical materials used to produce cleanroom gloves include nitrile, latex, neoprene, polychloroprene, and polyisoprene. An essential part of cleanroom gloves is a tight and secure fit such that the gloves are not loose and fit like a second skin. The class of gloves fit the class of the cleanroom with types designed for non-sterile and sterile environments.
In exceptionally restrictive cleanrooms, normal everyday clothing may not be worn even under coveralls. For the comfort of workers, manufacturers purchase intersuits that are worn under coveralls to meet the requirements of the cleanroom. Much like coveralls, intersuits are non-lint producing and are sealed by elastic material at the wrist and ankles.
An intersuit is designed to completely seal a worker‘s skin from contact with the atmosphere in the cleanroom. Once a worker is in their coveralls with gloves, foot coverings, and a mask, they are completely sealed from the air and environment in the cleanroom.
The cleaning of cleanrooms involves the use of several specialized products. Each cleanroom setting has a different type of cleaning challenge that necessitates a cleaner specifically designed for the cleanroom‘s conditions.
Cleanrooms are classified according to their particle count as defined in ISO 14644 and microbial counts as defined in ISO 14698. Further requirements and regulations are outlined by the Federal Drug Administration (FDA) and the European Union (EU). A major step toward meeting the various regulations is the use of well defined cleaning techniques as well as acceptable cleaners and disinfectants.
Cleaners and disinfectants use a wide spectrum of ingredients and compounds designed to clean and sanitize cleanroom surfaces.
Bacteriostatic disinfectant cleaners inhibit the growth of bacterial cells. They do this by blocking the metabolic action of bacterial cells by targeting the protein synthesis. The process does not kill the cells but prevents them from procreating and replicating their DNA.
The use of a bacteriostatic disinfectant controls and regulates the growth of bacterial cells but does not eliminate the bacteria. Continued use of bacteriostatic disinfectants will eventually lead to the extinction of bacteria.
Bactericidal disinfectant cleaners are antimicrobial cleaners that treat and kill bacteria. These compounds attack microbes by affecting their cell walls, lipids, enzymes, and protein synthesis. The disruption of the cell structure and blocking of the formation of new cells kills the cells, preventing any further growth.
The work of bactericidal cleaners is irreversible and is used to completely sterilize cleanrooms. The resulting effect is a hygienically and antiseptically clean environment.
Antibacterial cleaners stop the growth of bacteria and prevent it from entering an environment. They include ingredients that get embedded in surfaces to create an environment where bacteria cannot live. They are effective against a wide range of bacteria and other contaminants.
Antimicrobial cleaners function much like antibacterial cleaners but go much further in the destruction and prevention of bacterial growth. When an antimicrobial cleaner is introduced into the environment, it offers longer lasting protection and removes contaminants that may enter the environment.
A sporicidal cleaning agent destroys bacterial and fungal spores. The expectation for sporicidal cleaners is to destroy and remove contaminants. Sporicidal cleaning of cleanrooms is only necessary occasionally but is strongly recommended regardless of the lack of potential growth of spores.
Alcohol based disinfectants are the most commonly used method for decontaminating and hygienically cleaning. Mixed with water, alcohol, isopropyl or ethyl, offers a method of cleaning of virucidal properties. Isopropyl alcohol is especially effective in killing bacteria and viruses though it is ineffective against spores.
Formaldehyde cleaners penetrate deep into corners, spaces below furniture and equipment, and ventilation systems. When formaldehyde is used as a cleaner, the cleanroom has to be vacated for an extended period of time to allow the gas to dissipate; it must be filtered by carbon absorption filters.
Sodium hypochlorite (bleach) is a cost effective biocide that is widely used by several industries due to its ability to remove contaminants including spores. The use of bleach as a cleaner requires certain safety precautions, including proper protective clothing and avoidance of combination with other cleaners.
Hydrogen peroxide can be used as a method of sterilization and the control of sporicidal properties. For cleanroom purposes, hydrogen peroxide can be mixed with water to be used as a vapor. Cleanroom wipes are a common method for applying hydrogen peroxide. They serve as an effective method for preparing surfaces for a deeper cleaning since detergents and solvents normally leave a residue.
Peracetic acid is a combination of acetic acid and hydrogen peroxide and is an ideal method for removing contaminants; after use, it decomposes without a residue. It is a commonly used biocide for stream and cold sterilization applications such as endoscopes, arthroscopes, surgical tools, and dental instruments.
Isopropanol is a stronger form of isopropyl alcohol and is one of the more common forms of alcohol. A benefit of isopropanol is that it evaporates quickly but is able to dissolve a wide range of compounds. The high concentration of alcohol in isopropanol makes it capable of removing contaminants and protecting surfaces against bacterial infestation. It is widely used in cleanrooms and labs to disinfect and clean electrical components and lab equipment.
USP 800 cleaning is a four step process that involves a group of cleaners that will deactivate, decontaminate, clean, and disinfect.
Quaternary is an ammonia compound that is used in a wide range of cleaners including detergent and chemical disinfectants. It is known for killing pathogens such as fungi, amoebas, mold, several types of microbes, and various viral strains. Quaternary is an ideal cleaner for non-porous surfaces but is ineffective against bacterial endospores.
Keeping a cleanroom clean requires the use of products capable of sterilizing and cleansing it. An important part of the process is selecting products and equipment that are specifically designed for cleanroom use and will ensure the integrity of the room. The methods used to clean a cleanroom are carefully planned since any oversights or errors may declassify the room and require it to be reclassified and reapproved.
Various tools have been designed and tested as viable equipment for completing the cleaning process without damaging the room. The staff that cleans the room are specially trained and aware of each step of the cleaning process.
Tacky rollers are designed to remove particles from flat and slightly textured surfaces in a cleanroom including the floor, ceiling, and walls. The types of tacky rollers are film and foam with the film version ideal for flat surfaces while the foam version can clean textured surfaces.
A tacky roller is similar to a handheld lint roller but is in the form of a paint roller. In place of paint, sheets of sticky polyethylene are attached to the roller. When the roller passes over a surface, it grabs loose material and removes it.
Though a bucket may seem to be an inconsequential aspect of preparing a cleanroom, as with all parts of cleanrooms, there is a special set of procedures regarding using buckets for a cleanroom cleaning. Unlike mopping the floor of a room or hallway, more than one bucket is required to clean a cleanroom.
The two systems for mopping a cleanroom are differentiated by two versus three buckets. In most cases, the three bucket method is preferred, with one bucket with the cleaning solution, one with clean water, and one with the wringer. In the two bucket method, one bucket has the cleaner and the second bucket has the wringer. In either case, a cleaning mop is never wrung out in the cleaning solution bucket.
During its use, none of the fibers can fall out of a cleanroom broom. To ensure a secure tight fit, fibers are fused into a polymer block such that they remain tightly affixed and maintain their shape for visual code inspections.
The handles, fibers, and poly blocks must be non-conductive and unable to absorb bacteria, liquids, or odors. Each component of a broom is made to be unaffected by water, grease, petroleum products, detergents, sanitizers, and solvents. As an extra precaution, the fibers of brooms are disinfected between uses.
The first requirement of any mop for a cleanroom is that it be lint free and non-shedding. Mops for cleanrooms are made of stainless steel, aluminum, or plastic and are ergonomically designed for ease of use. Some designs are bucket-less with a cleaning solution injected into the head.
Depending on the cleanroom, mops can be sterile or non-sterile with sterile being the most common and required. For sterile environments, mop fibers are carefully selected such that they are autoclavable as well as chemical resistant.
Like the air filtration system of a cleanroom, a cleanroom vacuum has HEPA filters. Cleanroom vacuums are made of the same type of material used to create the tables, cabinets, and chairs for cleanrooms—stainless steel. In many ways, a cleanroom vacuum is very similar to a home vacuum, with attachments for every type of corner and niche. The difference between the two is the filtration system; a cleanroom vacuum has a four stage filtration process and can clean cleanrooms at an ISO 4 classification.
Floor squeegees are made of non-conductive PVC and designed to not absorb bacteria, liquids, or odors. As with most cleanroom equipment, they are exceptionally durable and are unaffected by water, grease, petroleum products, detergents, sanitizers, and solvents. They have dual blades that can be changed easily and quickly with a splash guard. The blades are made of a non-marring material that is tear resistant.
A cleanroom is a specially designed enclosed space where airborne particulates have been limited or removed by a highly sophisticated filtration system. They are used by industries that require a highly controlled and monitored environment for the production...
A modular clean room is a prefabricated, controlled environment that is constructed to limit the presence of sub-micron particulates. These specially designed rooms are assembled using prefabricated panels inserted into a frame. They are purchased as a kit to be assembled or can be constructed by a technician...
A portable cleanroom is a compact system that requires little space, provides mobility, is cost effective, and offers exceptional clean and filtered airflow to create an uncontaminated and sanitized environment. They are a modular designed room where...
A softwall cleanroom is a confined controlled space with a metal frame, clear panel walls, an entrance, high efficiency particulate air (HEPA) filters, and exceptional lighting that is designed to provide a contaminant and particulate matter free workspace...
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...
An altitude chamber is a test chamber that is designed to simulate the altitude, vacuum, and temperature of environmental conditions at heights that match the flight patterns of all forms of aircraft, from commercial to military...
A climate chamber is an enclosed space that provides a controlled set of circumstances for testing the impact of various environmental and climatic conditions on industrial goods, commercial products, electronic devices, materials, and biological matter...
A cold room is a temperature controlled environment that is capable, through refrigeration, to create conditions for storage, experimentation, and preservation of foods, equipment, and medical supplies. The types of cold rooms are...
An environmental chamber is an enclosure used to test the effects of a variety of conditions on a product, component, part, or assembly. These highly technical pieces of equipment are capable of simulating the types of conditions a product may face while in use...
A HEPA filter is a high efficiency pleated air filter capable of capturing extremely small particulate matter down to particles that are the size of a micron (µ), or a micrometer, which is 1/1000th of a meter...
A humidity chamber is a mechanism that examines how products react when exposed to variations in humidity. This type of environmental testing is used by manufacturers to test the various parameters of their products in the harshest of conditions...
Modular buildings are buildings made up of standardized sections, called "modules," manufactured in a controlled environment of a factory away from the building's future location. The common factory-made, standard modules include walls...
A portable office is a mobile workspace that can be easily assembled and placed to provide a quiet and convenient location for meetings, completing paperwork, or examining plans. They are built using...
Prefabricated buildings, or prefabs, are buildings with components (walls, roof, and floor) that are manufactured in a factory or manufacturing plant. These components can be fully or partially assembled in a factory which is then transferred at the construction site...
Stability chambers and rooms are climate-controlled environments that provide stable conditions for testing and storage. These specialized environmental chambers offer a precise, raised temperature or humidity to ascertain whether a...
A temperature chamber is a controlled environment capable of producing conditions that a product will encounter during its use. These highly controlled technical tools are able to produce the types of hazards, uses, and atmospheres a product may endure...
A test chamber is a managed and controlled environment used to test the endurance, stability, and practicality of equipment, products, and chemicals. They are a controlled enclosure that mimics the effects of environmental conditions that a product may encounter during its usage...
Thermal shock chambers are climatic chambers for thermal shock testing that are utilized to put the material to serious shocks. This is accomplished through the repeated and sudden passage to low temperature areas from...
A vacuum chamber removes air and pressure from a confined enclosure to test the effects of a vacuum on parts, materials, components, and assemblies. It can also be used to test the performance of applications for manufacturing operations...
The purpose of an environmental testing chamber is to examine the effects of a variety of climactic, physical, and other unique conditions on a product. They are designed to create environments that a product may encounter during its use...