Cleanroom Terminology:
a glossary of cleanroom terms

In cleanrooms, air cleanliness is usually measured by taking airborne particle counts with a particle counter. The cleaner the air, the higher class a cleanroom.

A device used to remove airborne contaminants. Most cleanroom air filters are composed of fibers which are designed to capture particulates like dust, bacteria, pollen, chemicals, and mold spores through adsorption, straining, absorption, or static electric charge.

A centralized unit that conditions and distributes air throughout a cleanroom. It typically handles heating, cooling, filtration, and humidity. In some cleanrooms, AHUs are replaced by smaller, decentralized fan filter units (FFUs).

A small room with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic processing airlock is to prevent ingress of particulate matter and microorganism contamination from a lesser controlled area.

A specialized chamber which utilizes forced air to remove any particulate matter from a person or object before accessing a cleanroom facility. In order to minimize contamination, a cleanroom air shower often uses air filters to capture any dust, bacteria, pollen, or mold that may be present on the surface of a person or object.

The rate of air movement measured in distance traveled relative to time elapsed. Air velocity is commonly measured in meters per second (m/s) or feet per minute (ft/min).

Airborne particle counts are an air sampling method, used to determine if a cleanroom is meeting the required particle concentration limits within its ISO 14644-1:2015 class parameters. They can be taken with a particle counter and will form part of a cleanroom validation check. They should also be taken regularly to ensure the cleanroom is still operating effectively between validations.

Airborne particles are sub-micron particles, which are invisible to the naked eye.

Stream of air as it passes over the surface of a moving object or within a wind tunnel where air may move over the surface of a stationary object.

The consistency with which a stream of air passes over the surface of an object. Measured in volume occupied relative to time elapsed. Common airflow uniformity is measured in cubic meters per second (m³/s), liters per second (L/s), or cubic feet per minute (ft³/min).

An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels and are established based on historical and qualification trend data and periodically reviewed.

ACOPs describe preferred or recommended methods that can be used (or standards to be met) to comply with regulations and the duties imposed by the Health and Safety at Work Act.

Commonly used acronym for Air Conditioning, Refrigeration, & Building Services. ARBS refers to a large trade event that is held every two years for heating, ventilation, air conditioning, refrigeration, and other building related industries.

A cleanroom that is complete, functional, and ready for operation, but without the equipment and personnel inside. Testing a cleanroom as-built reflects the quality of the supply air.

A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product.

The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms. This term is synonymous with “aseptic processing facility.”

A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.

A room in which one or more aseptic activities or processes are performed.

Commonly used acronym for the American Society of Heating, Refrigerating, and Air-Conditioning Engineers. This international organization has a mission to advance the HVAC & R (heating, ventilation, air-conditioning, and refrigeration) industries to better serve humanity and promote sustainability. ASHRAE accomplishes this mission through research, continuing education programs, and the writing and publishing of industry standards.

Often used for international cleanroom builds, an assisted build is where a small number of people from the cleanroom company oversee a team of subcontractors provided by the client, who conduct the cleanroom build. A major benefit of an assisted build is that it can keep costs down, as travel and accommodation requirements are significantly reduced.

A cleanroom that is complete, functional, and ready for operation, with the equipment inside, but without the personnel. Testing a cleanroom at-rest allows for smoke testing over critical equipment surfaces to check positioning.

The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that are designed to provide protection. It is a measurement of a material’s resistance to penetration of bacteria.

This test is performed to validate that a filter can remove bacteria from a gas or solution.

A physical partition that affords aseptic processing area (Grade A) protection by partially separating it from the surrounding area, such as RABS or isolators.

Classification used to determine the levels of containment a fume hood will provide in regard to potential contamination by hazardous vapors, gases, and particles.

Bioburden is the number of bacteria living on an un-sterilized surface. GMP Annex 1 describes it as “the total number of microorganisms associated with a specific item prior to sterilization.”

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials, or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

A biocide is a disinfectant with a broad spectrum of activity, especially against bacteria and fungi. Microbial contamination could consist of bacteria, fungi, viruses, or bacterial spores. Most biocides are not effective against bacterial spores, which pose a threat as they are difficult to kill and can lie dormant for extended periods of time.

A population of microorganisms inoculated onto a suitable medium (e.g. solution, container, or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI.

Blow-Fill-Seal (BFS) technology is a pharmaceutical filling process in which containers are formed from a thermoplastic granulate, filled with product, and then sealed in a continuous, integrated, automatic operation. The two most common types of BFS machines are the Shuttling machine (with Parison cut) and the Rotary machine (Closed Parison) types.

Emergency break-out panels provide a convenient and quick escape route from the cleanroom in the event of an emergency. Breakout panels should be clearly marked and need to be able to be removed in seconds to allow exit.

CFM is an abbreviation for cubic feet per minute (cu ft/min). When used in the context of a particle counter’s flow rate, it is a measurement of the velocity at which air flows into the sample probe. For example, a flow rate of 0.1 CFM means the particle counter will sample 0.1 cubic feet of air per minute.

A cleanroom change area, or gowning area, is a room in which personnel can don their cleanroom garments prior to entering the main cleanroom zone. Often this room is at a lower classification and pressure than the main area, so the pressure cascade is maintained. It is good practice for all cleanrooms to include a change area as it helps personnel adhere to gowning procedures.

Clean-in-place is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters, and associated fittings, without disassembly.

Classification levels that indicate the acceptable number of particles in a cubic foot of cleanroom space. Class levels are generally determined from the number of 0.5 micron or larger particles per cubic foot.

An area with defined particle and microbiological cleanliness standards.

An area that does not meet any of the formal pre-determined grades of cleanliness (i.e. Grades A to D), but where a manufacturer-defined level of microbial control is still required. The area should be subject to a formal cleaning/disinfection regime and environmental monitoring program. The level, type, and frequency of both programs should be based on a formal risk assessment and should be commensurate with the specific risks to the processes and products within each CNC area.

The removal of soils and residues (including biofilms) through use of a detergent. This should always be carried out before disinfection takes place.

A room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed, and operated in a manner to control the introduction, generation, and retention of particles inside the room.

Non-shedding apparel that is designed specifically to serve as a barrier between cleanroom environments and possible contaminants released by cleanroom workers. Cleanroom garments may include footwear, shoe covers, coveralls, gowns, smocks, gloves, face masks, and head coverings.

A classification system used to determine the acceptable concentration of particles in an identified volume of air given specific particle size parameters.

A space or system of spaces in which there are tightly controlled limits that govern airflow, air pressure, air filtration, temperature, relative humidity, viability of airborne particles, access, and operating procedures.

Furnishings that are designed specifically for convenient dispensing of cleanroom-safe products.

BS 8568:2013 is a code of practice for improving energy efficiency in cleanrooms and clean air devices. It gives recommendations on reducing energy consumption in areas such as facilities design, garment requirements, and operator competence.

The process of expanding an existing cleanroom by adding additional controlled space. Extensions must maintain the same air quality, pressure, and contamination control standards as the original cleanroom.

A cleanroom facility that is prepared for operation in terms of construction and systems but without staff present or manufacturing equipment in place.

A cleanroom facility that is fully equipped for operation with the exception of staff on site.

A cleanroom facility that is equipped and staffed for full operations, with all staff, equipment, and supplies present.

Specialized coatings used on cleanroom surfaces that are designed not to outgas or shed particles. Cleanroom paint must be durable, easy to clean, and resistant to the cleaning agents used in controlled environments.

The process of disassembling, transporting, and reassembling a cleanroom at a new location. Modular cleanrooms are particularly suited to relocation because their components are designed to be taken apart and rebuilt.

An area that provides full enclosure with controlled ventilation systems and regulated access.

A system in which the sterile product is not exposed to the surrounding environment.

CMC is an acronym for Chemistry, Manufacturing, and Controls, which are stages of the drug development life cycle.

A microbiological term that describes the formation of a single macroscopic colony after the introduction of one or more microorganisms to microbiological growth media. One colony forming unit is expressed as 1 CFU.

Activities to verify that equipment and systems are installed according to specification.

Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.

A material made up of two or more component parts to create a material with specialist properties to suit varying applications. For example, resin and fiber may be used to create a durable cleanroom worktop resistant to cleaning chemicals.

The utilization of filters and controlled ventilation systems in a designated space for capturing and containing potential contaminants.

When the floor is extended at the edges to curve up the wall, creating a smooth surface from wall to floor. A coved finish creates an easy-to-clean system and is one of the hallmarks of GMP design, making it the preferred choice for healthcare and medical cleanrooms.

An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas such as the Grade A area or a closed system.

Surfaces that may come into contact with, or directly affect, a sterilized product or its containers or closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is maintained throughout processing.

Particle counters display readings in two columns: cumulative (often depicted by ∑ sigma) and differential (often depicted by ∆ delta). The cumulative total shows the number of particles that were found at that size and greater. The differential total shows the counts which are at least that size in diameter and up to, but not including, the next size.

The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism.

Through a decentralized air handling approach, the same results can be delivered as with an AHU, but with a significantly reduced installation cost and running cost. By utilizing several smaller, localized inverter-driven temperature control units and ceiling-mounted HEPA fan filter units, a high level of resilience and modularity can be achieved. All controlled air is appropriately blended in ducting before introduction into the cleanroom.

A process that eliminates viable bioburden through the use of chemical agents.

Water that has been purified to a level where its ions have been removed, but not to the same degree as WFI.

Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative (depicted by ∑ sigma). The differential total shows the counts which are at least that size in diameter and up to, but not including, the next size. The cumulative total shows the number of particles that were found at that size and greater.

A process used to destroy or remove pyrogens (e.g., endotoxin).

A sealable enclosure that contains desiccants or nitrogen gas used to prevent reactions between moisture-sensitive materials and atmospheric humidity.

Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative (depicted by ∑ sigma). The differential total shows the counts which are at least that size in diameter and up to, but not including, the next size. The cumulative total shows the number of particles that were found at that size and greater.

The process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores.

Interlocked doors support good cleanroom entry and exit practices by only allowing one door to open at a time, preserving the cleanroom’s integrity.

A method of testing filter integrity in which oil is dispersed as an aerosol into the upstream flow of the filter media, while the number of particles in the downstream flow is measured using a calibrated photometer.

Documented proof that your cleanroom design is capable of compliance with regulatory and process needs.

A control system designed to ensure that a cleanroom operates effectively by constantly monitoring operating conditions within the area, raising alarms if any parameters vary beyond a specified threshold. This enables environmental monitoring of controls such as pressure differential, particle counts, temperature, and humidity.

The transfer of electric charge between two surfaces as a result of friction.

European Medicines Agency. An agency of the European Union.

A pyrogenic product (e.g. lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections, ranging from fever to death.

For cleanroom environments where electrostatic charge is a process risk, static dissipative clear panels are recommended. Panels should feature a conductive static dissipative surface coating on both sides.

A fan filter unit is a motorized unit which supplies clean, filtered air to a cleanroom.

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, cosmetics, animal foods and feed, and veterinary products.

The Federal Standard 209E “Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones” graded cleanrooms as Class 1/10/100/1,000/10,000/100,000. FED-STD-209E was discontinued in 2001 and superseded by the ISO standard. However, this standard is still retained on many comparison tables to maintain consistency between older and newer facilities.

A high-risk area in pharmaceutical manufacture, used for sterile filling.

Also known as Dispersed Oil Particulate (DOP) testing, filter integrity testing is the process in which the integrity of your HEPA or ULPA filter is challenged by introducing particulates upstream and measuring the output downstream.

The main cleanroom flooring options are loose-lay flooring and vinyl flooring.

The flow rate of a particle counter is the speed at which air is drawn through the sample probe. For example, a flow rate of 0.1 CFM means the particle counter will sample 0.1 cubic feet of air per minute.

A cabinet with inward airflow that protects the operator from dangerous or noxious vapors or particles.

A specification in which the demands of the manufacturer are transferred into a technical solution (from the manufacturer’s point of view). Also known as Functional Specification (FS).

A definition of requirements to fulfill the demands of the process (from the user’s point of view).

A sealed enclosure that incorporates built-in gloves, allowing operators to handle materials inside without direct contact. Gloveboxes are used in cleanrooms and laboratories where products or processes must be isolated from the surrounding environment.

Good Manufacturing Practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes.

A guide for the validation of automated systems in pharmaceutical manufacture.

Clothing worn in cleanrooms acts to protect the environment from the wearer, as opposed to safety PPE which protects the wearer from the environment.

A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner.

Approximate composition: 18% chromium, 8% nickel (exact composition ranges vary between EN and ASTM standards). This grade offers good corrosion resistance, good weldability, excellent ductility, and hygienic surfaces.

Approximate composition: 17% chromium, 10% nickel, 2% molybdenum (exact composition ranges vary between EN and ASTM standards). Molybdenum enhances the corrosion resistance of stainless steel even in relatively small amounts. In environments where 304 is found to be inadequate (e.g. due to harsh cleaning chemicals), 316 is the natural first grade to be considered.

Air which is passed through a filter qualified as capable of producing Grade A non-viable quality air, but where there is no requirement to continuously perform non-viable monitoring or meet Grade A viable monitoring limits.

A prefabricated room with rigid walls constructed to meet stringent cleanroom requirements. Hardwall cleanrooms may be incorporated into existing structures or may stand alone. They can be single-pass or recirculating, can sustain positive pressure, and can achieve ISO 3 through ISO 8.

A High Efficiency Particulate Air (HEPA) filter that meets specific standards for interception, impaction, and diffusion of airborne particulates.

A High Efficiency Particulate Air (HEPA) filter constructed to withstand high airflow levels. Measurements are estimated at 944 L/s at 350 Pa initial resistance.

A High Efficiency Particulate Air (HEPA) filter that is integrated into a disposable housing for use in cleanroom ceiling installations. HEPA filter modules are usually available in fan-assisted and non-fan-assisted variations.

HEPA filtration uses filter media which is efficient at removing submicron particles from the air.

Regulation of the degree of saturation (relative humidity) or quantity (absolute humidity) of water vapor in a mixture of air and water vapor.

HVAC is an acronym for Heating, Ventilation, and Air Conditioning.

A cleanroom which uses more than one type of wall construction. For instance, a hardwall cleanroom with a softwall change area.

Industry 4.0 refers to the fourth industrial revolution, characterized by the integration of digital technologies into manufacturing and industrial processes.

For optimum space utilization, integrated benching can be installed in cleanrooms.

The process of evaluating and confirming that the installed cleanroom is consistent with what was specified.

Cleanroom air cleanliness classifications that provide standards for the identification, control, and monitoring of various airborne particles and contaminants.

A decontaminated unit supplied with Grade A (ISO 5) or higher air quality that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel).

An air stream that flows through a HEPA filter and moves with uniform velocity within a confined space. Also referred to as “unidirectional flow,” laminar airflow generally moves along parallel flow lines.

Vertical laminar flow cabinets or booths that create either a localized clean environment or additional protection for critical processes within an existing controlled environment.

LED light fittings can be optimized to support minimum working plane lux requirements in cleanrooms.

An outlet at the bottom of a cleanroom where particles are flushed out due to the positive airflow and pressure differential. A full perimeter exhaust vent will allow an even airflow.

LPM is an abbreviation for liters per minute (L/min). When used in the context of a particle counter’s flow rate, it is a measurement of the velocity at which air flows into the sample probe. For example, a flow rate of 2.83 LPM means the particle counter will sample 2.83 liters of air per minute.

Lux is a measurement of light intensity. Getting the required lux levels right is important for the safe and effective operation of a cleanroom. Typically, the minimum lux requirements are driven by the production of small and sensitive components, where lighting levels need to be high enough so that processes are properly illuminated.

Magnehelic differential pressure gauges are used to ensure a positive pressure boundary is maintained between the cleanroom and less controlled areas.

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices, and blood components for transfusion in the UK. MHRA is an executive agency sponsored by the Department of Health and Social Care.

A unit of measurement equal to one-millionth of a meter or 0.00003937 inch. Expressed as µm and also referred to as a micrometer.

Prefabricated cleanroom units that are manufactured with self-contained ventilation and electrical systems that comply with industry standards. These are usually built in a manufacturing plant and assembled on site, and can be disassembled, relocated, and reassembled at any time.

Cleanroom systems featuring flush-fitting wall panels for reduced particle retention and superior load-bearing capacity. All seams are sealed to ensure there is no particulate retention.

An extended surface air filter that organizes the filter material in a series of pockets. The number and thickness of the filtration pockets may vary depending on the application.

NADCAP (National Aerospace and Defense Contractors Accreditation Program) is aimed at driving continual improvement for businesses within the aerospace manufacturing and defense industries. NADCAP accreditation leads to a standardized approach to quality assurance.

• As-built: The cleanroom is complete with all services connected and functioning but with no equipment, furniture, materials, or personnel present.
• At-rest: The cleanroom is complete with equipment installed and operating in a manner agreed upon, but with no personnel present.
• Operational: The cleanroom is functioning in the specified manner, with equipment operating and the specified number of personnel present.

Off-site construction offers a more accurate and timely installation with less chance of failure, with all elements being made and tested prior to delivery to site.

Opaque hardwall cleanroom panels provide good resistance to alcohol and solvents and give a bright, white, easy-to-clean finish to walls. This can be used for both interior and exterior divides and should be considered where solar heat gains could be an issue.

A cleanroom that is complete, functional, and ready for operation, with the equipment and personnel inside. Testing a cleanroom in its operational state allows for an accurate assessment of real working conditions.

Any individual participating in the aseptic processing operation, including line set-up, filling, maintenance, or other personnel associated with aseptic line activities.

The process of verifying that the cleanroom equipment is achieving the operational parameters specified.

A process that is sufficient to provide at least a 12-log reduction of microorganisms having a minimum D value of 1 minute.

A single- or double-layer filter that is either disposable or can be modified with replaceable filtration material. Most panel filters have a shallow profile with a thickness between 25–100 mm.

Cleanroom systems featuring flush-fitting wall panels for reduced particle retention and superior airtightness and load-bearing capacity.

A device that measures the size and quantity of particles per cubic volume of air. Used to determine the cleanliness rating of a cleanroom.

Minuscule segments of manmade or natural matter that have been suspended in gas or liquid.

A small chamber with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). Used to transfer materials between areas without compromising the cleanroom’s integrity.

A system that highlights the specific requirements for quality management when applied to the manufacture of sterile medicinal products.

Steel or aluminum that has been applied with a polyester powder coating. This provides a very even, semi-gloss finish that offers excellent resistance to various alcohols and solvents typically used to clean cleanroom facilities.

The process of confirming that the cleanroom equipment is performing together in an operational state.

A specialized filter that is designed to work with a downstream filter to guard against contamination from large dust particles.

Pressure cascades within a cleanroom environment ensure that the flow of air moves from clean to less clean areas. They are created by using airflow to create pressure differentials between zones. Pressure management is critical to the effective performance of a cleanroom, keeping contamination from reaching the critical process environment.

A pressure differential is a difference in pressure between two points in a system. Within the cleanroom industry, pressure differentials are used to create pressure cascades to control the flow of contamination. See Pressure Cascade.

Establishing documented evidence that provides a high degree of assurance that equipment or facilities will perform to the required specification detailed in the user requirement specification and the design qualification.

Rapid roll doors are effective at providing a large opening into a cleanroom for goods in and out. Cleanroom-compatible doors require limited space and are ideal for interlocks.

A restricted access barrier system (RABS) provides an enclosed, but not fully closed, environment meeting defined cleanroom conditions using a rigid-wall enclosure and air overspill to separate its interior from the surrounding environment.

To control bioburden in a cleanroom, disinfectants are used to kill microorganisms. Because microorganisms can develop resistance to a single disinfectant, two or more disinfectants are used in rotation. This practice is called rotational cleaning.

The documented written program of cleaning and disinfecting cleanroom surfaces.

Particle counters display readings in two columns: cumulative (often depicted by ∑ sigma) and differential (often depicted by ∆ delta). The cumulative total shows the number of particles that were found at that size and greater. The differential total shows the counts which are at least that size in diameter and up to, but not including, the next size.

A cleanroom door encased in a frame, designed to incorporate into modular hardwall systems. With a compact profile, it is designed for use in slim-line partition systems and features a hygienic, easy-to-clean powder coat finish.

Systems in which some product-contact components are used only once to replace reusable equipment such as stainless steel transfer lines or bulk containers. SUS are commonly used in manufacturing processes of sterile medicinal products and are typically made up of components such as bags, filters, tubing, connectors, storage bottles, and sensors.

Where access requirements, room configuration, or size demand an alternative to a swing door, a cleanroom sliding door provides a practical alternative. Sliding doors are produced using controlled manufacturing processes and corrosion-inhibiting steel sheets which are internally bonded with a strengthening honeycomb core.

Softwall panels provide an economical, effective, and durable barrier against the uncontrolled environment outside of the cleanroom, as well as good resistance to alcohol and solvents. A distinct advantage is that only a small aperture is created when entering or exiting the cleanroom, quickly restoring the barrier once passed.

A sporicidal is a disinfectant that is effective against bacterial spores. They can be aggressive enough to be harmful to health or equipment, and are therefore not suitable for frequent use. Bacterial spores pose a particular threat as they are difficult to kill and can lie dormant for extended periods of time.

Stainless steels are iron-based alloys containing 10.5% or more chromium. They have been used for many industrial, architectural, chemical, and consumer applications for over half a century.

Static electricity is a form of electricity at rest caused by an imbalance at a molecular level within a material.

A closed and validated trigger spray system that ensures content sterility throughout use, designed for the cleaning and disinfection of critical areas like cleanrooms.

A dedicated air supply that has been filtered to remove bacteria, viruses, yeasts, molds, and other microbiological organisms.

A sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.

A filter that, when appropriately validated, will remove a defined microbial challenge from a fluid stream, producing a sterile effluent.

Floor mats which remove contaminants from shoes or wheels as they contact its sticky surface. Sticky mats come in a permanent washable option or as disposable peel-off mats consisting of multiple layers of tacky plastic film which are peeled off as they get dirty.

See Sticky Mat.

An airtight voice communication device that can be mounted on a number of surfaces, including glass, plastic, Plexiglas, wood, and many other wall materials. Sound is transferred through a thin Mylar diaphragm, while visual communication is achieved through a small window. A sealed plastic frame is mounted on both sides of the cleanroom wall or window surface.

In cleanrooms, particle control and temperature and humidity performance need to be balanced to create a repeatable environment. Cleanroom performance can be delivered from air conditioning systems based on localized AC units, with all controlled air blended in the ducting before introduction into the cleanroom through ceiling-mounted HEPA fan filter units.

The application of a lethal sterilizing agent to a finished product within a sealed container to achieve a predetermined sterility assurance level (SAL) of 10⁻⁶ or better (i.e. the theoretical probability of there being a single viable microorganism present on or in a sterilized unit is equal to or less than one in a million).

ULPA stands for Ultra-Low Penetration Air. A ULPA filter has an efficiency rating of 99.9995% on 0.12 micron particles. ULPA filters are usually used to create ISO 4 (Class 10) or ISO 3 (Class 1) cleanrooms.

An air stream that flows through a HEPA filter and moves with uniform velocity within a confined space. Airflow in a unidirectional flow cleanroom generally moves along parallel flow lines.

A definition of requirements to fulfill the demands of the process, written from the user’s point of view.

To supplement standard cleanroom lighting, UV lamps and UV light equipment can be used for both inspection and disinfection processes.

Procedures for the monitoring and documentation of compliance to specified regulations for the design, construction, and performance of a clean manufacturing facility.

Vaporized hydrogen peroxide (VHP) has antimicrobial properties and is used for decontamination and sterilization applications, with an added benefit of working at low temperatures. With a wide kill spectrum that includes bacteria, spores, fungi, and viruses, VHP decontamination chambers can be preferred to autoclaves as they put less pressure on products and use less energy.

A vent protector prevents large objects from entering the cleanroom through ventilation openings.

Management of the environment in which silicon wafers are used for chip production. Proper wafer handling usually involves cleanroom standards for facility, apparel, and equipment.

Water that has been produced to the highest level of purity, used in solutions that could be injected into the body. WFI has very low particulate content and very high purity. If the water contains any impurities or tiny particles of metal, such as copper or lead, it can cause adverse health effects.

A free-standing station for use in labs or cleanrooms for safe and functional semiconductor processing, chemical analysis, plating, microelectronic manufacturing, and other custom processing. Operates under negative pressure to protect the operator from harmful vapors.

A three-step sterile cleaning kit designed to address USP 800 requirements by deactivating most hazardous drugs while staying USP 797 compliant.

A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.