Introduction to Cleanrooms 264

ACH

Air changes per hour. The number of times the total volume of air in any given space is replaced with supplied air each hour. ACH is important for determining the class of a cleanroom.

aerospace

The industry concerned with the research, design, manufacture, and operation of air and space craft. The aerospace industry uses cleanrooms for preserving experiment results and manufacturing sensitive electronic components.

air changes per hour

ACH. The number of times the total volume of air in any given space is replaced with supplied air each hour. Air changes per hour is important for determining the class of a cleanroom.

air pollutants

A substance that contaminates the air. Air pollutants are carefully tracked in cleanrooms.

air pressure

The force that air exerts due to collisions. Air pressure can change the direction in which contaminated air flows throughout a cleanroom.

air shower

A self-contained air recirculation system at the entry of a cleanroom that blows air over employees or equipment to remove contaminants. An air shower helps prevent contaminants from entering cleanrooms and dry rooms.

airborne contaminants

Any element or substance that moves through or by the air and causes a loss of efficiency or a breakdown of a product. Airborne contaminants, such as bacteria, viruses, skin cells, and dust, must be monitored in a cleanroom.

airlock

A chamber with two airtight doors or openings that do not open simultaneously. Airlocks are vital to preventing contamination from entering or escaping a cleanroom.

alcohol

An organic compound that is often used in cleaning products. Alcohol kills microorganisms to prevent contamination.

antiseptics

A cleaning product that cleans living tissue like skin to reduce the number of microorganisms on it. Antiseptics include soap for handwashing and hand sanitizer.

antistatic devices

A type of safety equipment that prevents the buildup of static electricity. Antistatic devices, such as antistatic wrist straps or mats, preserve the quality of static-sensitive electronic products.

aseptic

A process that takes place in a sterile environment or on surfaces that may still contain some microorganisms. Aseptic processes attempt to control the environment and prevent contamination of a sterile area.

ASTM International

An organization that writes and updates standards for a broad range of materials, including metals. ASTM International, formerly the American Society for Testing and Materials (ASTM), helps regulate manufacturing processes for a range of industries, including automotive and aerospace.

bacteria

A biological contaminant that may be harmful to inhale or ingest. Bacteria carried by humans can lead to contamination.

biohazards

A biological material that poses a threat to human health and safety. Biohazards include medical waste and anything potentially contaminated with bloodborne pathogens.

bouffant cap

A loose covering that secures around the head with an elastic band. A bouffant cap is used in a cleanroom to prevent hair from contaminating sensitive products.

charged particles

An atom or molecule with a positive or negative charge. Charged particles, also known as ions, like sodium, which can be found in water, can cause contamination.

chemical-resistant gloves

A hand covering that protects the skin against dangerous chemicals as well as cuts, burns, and contamination. Chemical-resistant gloves are used in manufacturing processes that use dangerous chemicals.

chemicals

Any element, compound, or mixture of elements and/or compounds. Chemicals may be in the form of solids, liquids, or gases and may be used for cleaning surfaces to prevent contamination.

chlorine compounds

A chemical mixture that is used for a wide range of applications, including cleaning. Chlorine compounds kill microorganisms to prevent contamination.

clean room

An area where contaminants, temperature, pressure, static electricity, humidity, or other environmental conditions are controlled but that may or may not be required to follow ISO cleanroom standards. The term "clean room" may be used synonymously with "cleanroom," but using the term "controlled environment" helps prevent confusion.

cleanroom

A room in which variables like temperature, humidity, and air pressure are controlled and maintained. Cleanrooms are required to follow ISO standards.

cleanroom wipes

A special type of cloth made of microfibers to decrease the amount of particles generated when cleaning. Cleanroom wipes should be used instead of paper towels or regular cloths to prevent contamination.

consumers

A person who purchases products or services. Consumers expect products to be safe and functional and become distrusting of brands when they are not.

contaminants

Any element or substance that makes an environment, product, or research process impure. Contaminants include skin cells, water, air pollution, biohazards, and other undesired particles.

controlled environments

An area where contaminants, temperature, pressure, static electricity, humidity, or other environmental conditions are controlled but that is not required to follow ISO cleanroom standards. The term "controlled environment" is preferred over the term "clean room" to help prevent confusion with "cleanroom."

coveralls

An article of protective clothing that covers the entire body from wrists to ankles. Coveralls may be used in conjunction with other layers for strict cleanroom classes.

cubic meter

m³. A metric unit of volume equal to the amount of space in a cube with edges that are one meter in length. Cubic meters are used to measure the concentration of particles in a cleanroom.

current

The flow of electricity. Current is produced by the movement of electrons.

Current Good Manufacturing Practices

cGMP. A set of standards enforced by the FDA that outline processes, procedures, and documentation for food, cosmetics, medical devices, and pharmaceutical goods. Current Good Manufacturing Practices work in tandem with ISO for cleanrooms.

decontamination

Removing particles that could cause contamination using various cleaning methods. Decontamination removes different amounts and types of particles depending on the cleaning method.

disinfectants

A cleaning product that cleans inanimate objects to kill microorganisms. Disinfectants often use alcohol or chlorine compounds and are used in cleanrooms to help further prevent contamination.

dry room

A type of cleanroom that is completely sealed and maintains a lower humidity of 1% or below. Dry rooms prevent moisture from contaminating sensitive electronic components.

exhausts

A series of devices that draw air into or out of a cleanroom. Exhausts vary depending on the type of air pressure and airflow used in a cleanroom.

face mask

An item of protective material that is made from multiple layers of cotton or other tightly woven material and fits snugly over the nose and mouth. Face masks help prevent contamination and offer different levels of protection based on their material.

face shield

A protective device that guards the face and eyes. Face shields are required PPE when working with dangerous chemicals.

FED-STD-209E

An outdated U.S. standard for cleanrooms that detailed classes of cleanrooms and requirements. FED-STD-209E has been replaced by ISO 14644.

filter coverage

The percentage of a cleanroom's ceiling that is made up of filters. Filter coverage requirements vary based on the cleanroom class, but ISO Class 4 and above require 100% coverage.

Food and Drug Administration

FDA. A U.S. federal agency that protects public health by ensuring foods, drugs, and medical treatments are safe, effective, and truthfully labeled. The Food and Drug Administration supplements standards for cleanroom processes, usually by specifying additional cleaning methods.

fungi

A biological contaminant that absorbs sustenance from other dead or living organisms. Fungi can lead to the contamination of research or products and render them unusable.

gases

An air-like fluid that expands freely to fill any space available, regardless of quantity. Gases are used for machine cleaning and can introduce contamination.

goggles

A type of tight-fitting eye protection that completely covers the eyes, eye sockets, and surrounding facial area. Goggles protect the wearer from contamination and prevent human contamination.

gowning

The act of putting on PPE prior to entering a cleanroom. Gowning is an important process for preventing contamination in the cleanroom.

gowning room

A room before the entrance of a cleanroom where technicians put on their required personal protective equipment. Gowning rooms help prevent the contamination of cleanrooms.

gowns

A protective full-body cover that reduces human contamination and exposure to contamination. Gowns for cleanrooms come in a variety of synthetic materials, including rubberized fabrics, neoprene, and polyester.

hardwall

A modular cleanroom composed of an aluminum frame and prefabricated panels. Hardwall cleanrooms comply with the strictest ISO requirements.

heat gain

The rise in temperature in a given space, which can result from a variety of sources like body heat and heat generated by machinery. Heat gain can impact the temperature of a cleanroom and cause issues like increased humidity.

heating, ventilation, and air conditioning

HVAC. A system that controls climates in spaces like vehicles, buildings, and rooms. Heating, ventilation, and air conditioning systems in cleanrooms must be high quality.

high-efficiency particulate air filters

HEPA filters. A disposable, dry filter encased in metal or cardboard. High-efficiency particulate air filters are normally paper and regulated to extract at least 99.97% of particles, such as skin cells and dust, from the air.

hood

A covering that covers the head, neck, and shoulders and may cover the face, leaving a hole for the eyes. A hood is used in strict cleanroom classes.

horizontally

Parallel to the horizon or ground. Air flows horizontally during laminar airflow.

humidity

The amount of water vapor in the air. Humidity control is important for maintaining a contaminant-free environment in a cleanroom.

HVAC

Heating, ventilation, and air conditioning. A system that controls climates in spaces like vehicles, buildings, and rooms. HVAC systems in cleanrooms must be high quality.

International Organization for Standardization

ISO. A nongovernmental organization based in Switzerland that develops and establishes standards and guidelines designed to ensure that products, processes, and services are fit for their purpose. The International Organization for Standardization provides standards for cleanrooms across all industries.

ionic contamination

A type of contamination that results from unwanted moisture or charged particles in a product. Ionic contamination can cause pills to form improperly or electronic components to malfunction.

ionizers

A device that uses high voltage to electrically charge air molecules into a neutral state. Ionizers are used in cleanrooms to prevent electrostatic discharge and electrostatic attraction.

ions

An atom or molecule with a positive or negative charge. Ions, also known as charged particles, like sodium, which can be found in water, can cause contamination.

ISO

The International Organization for Standardization. A nongovernmental organization based in Switzerland that develops and establishes standards and guidelines designed to ensure that products, processes, and services are fit for their purpose. ISO provides standards for cleanrooms across all industries.

ISO 14644

An ISO standard that provides specifications for designing, constructing, validating, and operating cleanrooms. ISO 14644 applies across numerous industries.

ISO classes

A category created by ISO that specifies the level of cleanliness in a cleanroom based on its design and operation. ISO classes range from 1 to 9, with 1 being the strictest class.

isopropyl alcohol

A colorless, flammable chemical compound with a strong odor used to clean and sterilize surfaces. Isopropyl alcohol can be used to wipe down equipment before it enters a cleanroom.

laminar airflow

A type of air circulation system that directs air in a constant stream downwards or horizontally towards filters on the walls or floors for recirculation. Laminar airflow, which is also called unidirectional airflow, is the most common air circulation system used for cleanrooms.

latex gloves

A protective hand covering made from a type of rubber called latex, which may be synthetic or natural. Latex gloves protect against contamination and electrostatic discharge.

lithium-ion battery

Li-Ion. A type of secondary cell battery that uses a lithium compound as a cathode and usually graphite or carbon as an anode. Lithium-ion batteries require cleanrooms during manufacturing to prevent contamination.

metallic

A material made from metal. Metallic particles can alter the flow of current in an electronic component.

microchips

A minuscule device that conducts electricity and transfers data. Microchips are used in an array of electronics and are sensitive to moisture and static electricity.

microelectronics

The industry concerned with miniaturized electronic devices, including microchips and microcircuits. The microelectronics industry relies on semiconductor devices and cleanrooms.

microns

µm. A metric unit of measurement equal to one thousandth of a millimeter. Microns are used to measure the size of particles.

microorganisms

An organism of microscopic size. Microorganisms include bacteria, viruses, fungi, and mold.

modular cleanrooms

A type of cleanroom that is prefabricated and assembled on-site. Modular cleanrooms are cost-effective and built from prefabricated components like walls and airlocks.

nanotechnology

An extremely small product or device developed by working with atoms and molecules with dimensions of less than 100 nanometers. Nanotechnology production requires cleanrooms to ensure functionality and purity of the finished product.

negative air pressure

Air pressure in a cleanroom that is lower than the pressure outside of the room, which prevents air from leaking out of the cleanroom. Negative air pressure is used for laboratories that handle biohazards to prevent dangerous contamination from leaving the lab.

neoprene apron

A long garment made of a lightweight synthetic material similar to rubber designed to protect the wearer from splashing fluid or other dangerous substances. Neoprene aprons are worn in conjunction with coveralls when dangerous chemicals are used in a cleanroom.

noise

A sound that is typically unpleasant and capable of interfering with a person's hearing. Noise can cause vibrations that interrupt high-precision work.

nonabsorbing

A material that is resistant to absorbing liquid through its surface. Nonabsorbing materials include nylon and polyester.

non-laminar airflow

A type of air circulation system that causes air to flow in a turbulent way along random paths to optimize the mixing of clean air with contaminated air. Non-laminar airflow systems, which are also called non-unidirectional airflow systems, are used for less strict cleanrooms.

nonmetallic

A material that is not made from metal, such as plastic, ceramic, or organic materials like skin cells and pollen that come from humans or the environment. Nonmetallic particles can cause a microelectronic device to malfunction.

nonreactive

A material that does not undergo changes when in contact with another material or substance. Nonreactive materials include stainless steel and glass.

nonshedding

A material that does not release particles or fragments of itself, such as lint. Nonshedding materials include polyester and stainless steel.

nonsterile pharmaceutical compounds

A medication that is produced in a controlled environment that may contain some microorganisms. Nonsterile pharmaceutical compounds include creams, ointments, and liquids.

non-unidirectional airflow

A type of air circulation system that causes air to flow in a turbulent way along random paths to optimize the mixing of clean air with contaminated air. Non-unidirectional airflow systems, which are also called non-laminar airflow systems, are used for less strict cleanrooms.

nuclear power

The industry that researches and produces energy using atomic reactions. The nuclear power industry requires cleanrooms to prevent the escape of nuclear material and radiation, which are harmful to humans.

Occupational Safety and Health Administration

OSHA. A federal agency under the U.S. Department of Labor that ensures safe working conditions and helps employers reduce injuries, illnesses, and deaths in the workplace. The Occupational Safety and Health Administration creates regulations that ensure employees work in a safe and healthy environment.

optics

The industry that studies the behavior of light and manufactures lenses and other optical equipment. The optics industry uses contaminant-sensitive technology, which requires the use of cleanrooms.

OSHA

Occupational Safety and Health Administration. A federal agency under the U.S. Department of Labor that ensures safe working conditions and helps employers reduce injuries, illnesses, and deaths in the workplace. OSHA creates regulations that ensure employees work in a safe and healthy environment.

particle count tests

A measurement of the number and size of particles in a fixed amount of space. Particle count tests can be performed in different ways, but using a particle counter is the most common method.

particles

A relatively small portion of matter. Particles can be airborne or on surfaces and lead to contamination.

particulate contamination

A type of contamination that results from unwanted nonmetallic or metallic particles entering a product. Particulate contamination can occur when dust or skin cells enter a microelectronic component, causing it to function improperly.

personal protective equipment

PPE. An item of safety equipment that employees wear or use to minimize exposure to hazards, prevent injury, or reduce contamination. Personal protective equipment for cleanrooms includes safety glasses, gloves, masks, coveralls, and earplugs.

pharmaceuticals

The industry that researches and manufactures medicinal drugs. The pharmaceutical industry uses cleanrooms to prevent unwanted substances from entering medications.

polyester

A plastic material that is often used to create fibers for synthetic fabrics. Polyester fabric is used for some cleanroom personal protective equipment.

positive air pressure

Air pressure in a cleanroom that is higher than the pressure of the air outside the room, which allows clean air to leak out but prevents contaminated air from coming in. Positive air pressure is found in the majority of cleanrooms.

PPE

Personal protective equipment. An item of safety equipment that employees wear or use to minimize exposure to hazards, prevent injury, or reduce contamination. PPE for cleanrooms includes safety glasses, gloves, masks, coveralls, and earplugs.

radiation

A type of energy emitted in the form of particles or waves. The usage of radiation requires cleanrooms to protect humans.

relative humidity

RH. The amount of water in the air at a given temperature compared to the maximum amount of water the air could hold at that temperature. Relative humidity is an important factor for keeping cleanrooms free from contamination.

respirator

A breathing device worn to prevent inhalation of hazardous substances. A respirator comes in one of various types that filter out chemicals and particulate matter to protect against contamination.

rigidwall

A modular cleanroom with transparent walls. Rigidwall cleanrooms are popular for the automotive, aerospace, medical device, and plastic manufacturing industries and meet ISO Class 4 to 8 requirements.

robots

A mechanical device that can be programmed to perform a variety of complicated, repetitive tasks. Robots are used in the strictest cleanrooms to prevent human contamination.

semiconductors

A material or element that has more electrical conductivity than an insulator but less than a conductor. Semiconductors are very sensitive to contamination and require cleanrooms during manufacturing.

separative devices

A piece of cleanroom equipment that creates a divide between defined spaces. Separative devices include clean air hoods, containment enclosures, gloveboxes, isolators, and mini-environments.

shoe covers

A disposable plastic barrier that fits over a shoe. Shoe covers prevent technicians from contaminating an area with the debris on their shoes.

softwall

A modular cleanroom that uses a minimalist and lightweight design with a steel or aluminum frame and ceiling grid. Softwall cleanrooms are generally used for ISO Classes 4 to 8.

stainless steel

A grouping of steels that contain large percentages of chromium, as well as nickel, manganese, and/or nitrogen. Stainless steels are used in cleanrooms because they are nonshedding, nonabsorbing, and nonreactive.

static electricity

An electrical charge caused by the buildup of friction in a person or object. Static electricity can ruin sensitive electronic devices, but it can be controlled in cleanrooms by using antistatic safety accessories.

static-dissipative

A material or object that conducts electricity away from a person or object and into the ground or floor. Static-dissipative PPE is often used in cleanrooms that manufacture electronics.

sterile

An environment or surface that does not contain any microorganisms. Sterile processes are necessary for industries like food manufacturing and for preserving research results.

sterile hazardous compounds

A medication that is toxic to humans or animals and is produced in an environment free of harmful microorganisms. Sterile hazardous compounds may require decontamination and cleaning procedures, deactivation, or spill control.

sterile nonhazardous compounds

A medication that is produced in an environment free of bacteria, viruses, and any other potentially harmful microorganisms. Sterile nonhazardous compounds include medications that require injection into the body.

sterilization

Removing, killing, or deactivating all forms of life present in or on a specific surface, object, or fluid. Sterilization can be achieved through various means, including heat, chemicals, irradiation, high pressure, and filtration.

stick-built cleanrooms

A type of cleanroom that is built on-site using a metal frame and parts. Stick-built cleanrooms are used for less strict cleanroom classes.

sticky floor

A permanent flooring, generally made of a polymer, that uses electrostatic attraction to capture particles. A sticky floor prevents technicians from carrying contaminants on their shoes into cleanrooms.

sticky mat

A piece of material placed on a floor with an adhesive surface located at the entrance or exit of a cleanroom that traps particles on shoes or the wheels of equipment being transported. A sticky mat must be replaced frequently because its efficacy decreases over time.

troubleshooting

A systematic approach to solving problems quickly and efficiently. Troubleshooting often involves a logical process of elimination to identify the source of a problem.

U.S. Pharmacopeia

USP. An organization that provides standards for developing, manufacturing, and packaging pharmaceutical products for use in animals or humans. The U.S. Pharmacopeia designates three different standards based on the type of product being manufactured and whether it is sterile or hazardous.

ultrafine particulate processing

The production and manipulation of extremely small particles in the nanometer to micrometer size range. Ultrafine particulate processing occurs in nanotechnology production and requires strict cleanrooms.

ultra-low particulate air filters

ULPA filters. A disposable, dry filter encased in metal or cardboard capable of filtering 99.99% of particles from the air. Ultra-low particulate air filters are used for the strictest cleanroom classes.

ultraviolet light

UV light. Light that is invisible to the naked eye because it consists of very short wavelengths. Ultraviolet light can eliminate contaminants such as bacteria, viruses, and dust.

unidirectional airflow

A type of air circulation system that directs air in a constant stream downwards or horizontally towards filters on the walls or floors for recirculation. Unidirectional airflow, which is also called laminar airflow, is the most common air circulation system used for cleanrooms.

vibration

A rapid, steadily repeating movement. Vibrations can cause sensitive products to fail.

vibration isolation workstations

A table that uses various technologies to reduce the transmission of vibration to objects on its surface. Vibration isolation workstations are necessary for high-precision work, such as semiconductor fabrication.

viruses

An infective contaminant that requires a living host to multiply. Viruses can be brought into cleanrooms by humans and cause contamination.