Glossary

Welcome to the first ever industry leading Cleanroom Glossary supplied to you by Connect 2 Cleanrooms Ltd. Browse the Glossary to find explanations to cleanroom terms that you may not be familiar with.

  • A/C

    Cleanroom Air Conditioning

  • Action Level

    An established microbial or airborne particle level that, when exceeded, should trigger appropriate...

  • Actuators

    An actuator is a mechanical component that can move a mechanism or system.

  • Adjustable height feet

    Feet that can be adjusted to ensure a level system is created, even on uneven floors.

  • Advisory Committee on Dangerous Pathogens

    The Advisory Committee on Dangerous Pathogens' (ACDP) role is to provide scientific advice on the ri...

  • Air changes per hour

    The amount of time a cleanroom can completely replace its air volume within an hour.

  • Air cleanliness

    With regards to cleanrooms, air cleanliness is usually measured by taking airborne particle counts w...

  • Air Conditioning

    See temperature and humidity control

  • Air differential

    Air differential

  • Air handling units (AHU)

    Connect 2 Cleanrooms support the implementation of Air Handling Units only in certain circumstances.

  • Air lock

    A small room with interlocked doors, constructed to maintain air pressure control between adjoining...

  • Airborne particle counts

    Airborne particle counts are an air sampling method, used to determine if a cleanroom is meeting the...

  • Airborne particles

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

  • Alert Level

    An established microbial or airborne particle level giving early warning of potential drift from nor...

  • ANVISA

    The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, par...

  • Approved Code of Practise (ACOPs)

    ACOPs describe preferred or recommended methods that can be used (or standards to be met) to comply...

  • As-built cleanroom

    A cleanroom that is complete, functional and ready for operation, but without the equipment and pers...

  • Asepsis

    A state of control attained by using an aseptic work area and performing activities in a manner that...

  • Aseptic Manufacturing Area

    The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms...

  • Aseptic Processing Facility

    A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and e...

  • Aseptic Processing Room

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

  • Assisted build

    A major benefit of an assisted build is that it can keep costs down, as travel and accommodation req...

  • At-rest cleanroom

    A cleanroom that is complete, functional and ready for operation, with the equipment inside, but wit...

  • Bacterial Filtration Efficiency (BFE)

    The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that...

  • Bacterial retention testing

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

  • Barrier

    A physical partition that affords aseptic processing area (grade A) protection by partially separati...

  • Bioburden

    Bioburden is the number of bacteria living on an un-sterilised surface. See Rotational Cleaning f...

  • Biocidal Products Regulation (BPR)

    The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market...

  • Biocide

    Many biocidal disinfectants have a broad spectrum of activity, especially against bacteria and fungi...

  • Biological Indicator (BI)

    A population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closur...

  • Blow-Fill-Seal (BFS)

    Blow-Fill-Seal (BFS) technology is a pharmaceutical filling process in which containers are formed f...

  • Breakout Panel

    Breakout panels should be clearly marked and need to be able to be removed in seconds to allow exit....

  • CFM

    CFM is an abbreviation for cubic feet per minute (cu ft/min). When used in the context of a particle...

  • Change area

    It is good practice for all cleanrooms to include a change area as it helps operatives adhere to gow...

  • CIP

    Clean in Place products and processes - Clean-in-place is a method of cleaning the interior surfaces...

  • Clean Area

    An area with defined particle and microbiological cleanliness standards.

  • Clean Non Classified (CNC) area

    An area that does not meet any of the formal pre-determined grades of cleanliness included in the An...

  • Cleaning

    The removal of soils and residues (including biofilms) through use of a detergent. This should alway...

  • Cleanroom

    A cleanroom is a "room within which the number concentration of airborne particles is controlled.......

  • Cleanroom extension

    A cleanroom may need to be extended to allow organisations to react to increased market demand.

  • Cleanroom relocation

    There are a number of reasons for which a cleanroom may need to be relocated.

  • Closed system

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

  • CMC Pharmaceuticals

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

  • Colony Forming Unit (cfu)

    A microbiological term that describes the formation of a single macroscopic colony after the introdu...

  • Commissioning

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

  • Component

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

  • Composite

    A material made up of 2 component parts, typically resin and fibre, used to create strong but lightw...

  • Coved floor

    When the floor is extended at the edges to be applied up the wall, creating a curved surface from wa...

  • Critical Area

    An area designed to maintain sterility of sterile materials. Sterilized product, containers, closure...

  • Critical surfaces

    Surfaces that may come into contact with, or directly affect, a sterilized product or its containers...

  • Cumulative particle counts

    Particle counters display readings in two columns: cumulative (often depicted by ∑ sigma) and differ...

  • D value

    The time (in minutes) of exposure at a given temperature that causes a one-log or 90 per cent reduct...

  • De-centralised air handling

    Through a de-centralised air handling approach, the same results can be delivered as with an AHU, bu...

  • De-ionised water (DI water of DIW)

    Deionized water is water that has had almost all of its mineral ions removed, however deionization d...

  • Decontamination

    A process that eliminates viable bioburden via use of chemical agents.

  • Delta (∆) column of particle counts

    Particle counters display readings in two columns: differential (often depicted by ∆ delta) and cumu...

  • Depyrogenation

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

  • Dew point

    Dew point (dp) is the temperature that a volume of air reaches when it becomes saturated with water...

  • Dewpoint vs humidity

    Dewpoint (dp) is the temperature that a volume of air reaches when it becomes saturated with water v...

  • Differential particle counts

    Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative...

  • Disinfection

    The process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection a...

  • Door interlock

    Interlocked doors support good cleanroom entry and exit practices by only allowing one door to open...

  • DOP Testing

    Dispersed Oil Particulate (DOP) testing, is the process in which the integrity of your HEPA (High Ef...

  • DQ - Design Qualification

    Design Qualification (DQ) is the documented verification that the proposed design of the facilities,...

  • ECO Cleanroom Control

    Environmental monitoring of controls such as pressure differential, particle counts, temperature & h...

  • EMA

    European Medicines Agency. European Union agencies network

  • Endotoxin

    A pyrogenic product (e.g. lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead...

  • ESD Hardwall cleanroom panels

    For cleanroom environments where electrostatic charge is a process risk, static dissipative clear pa...

  • Fan Filter Unit (FFU)

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

  • FDA - Food and Drugs Administration

    The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department...

  • Federal standards for cleanrooms

    Now defunct, the U.S. Federal Standard 209E Cleanroom Standards were the U.S. General Service Admini...

  • Filling zone

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

  • Filter integrity testing

    See DOP testing

  • Flooring

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

  • Flow rate

    The flow rate of a particle counter is the speed in which air is drawn through the sample probe. For...

  • Functional Design Specification (FDS)

    Specification in which the demands of the manufacturer are transferred into a technical solution (fr...

  • Functional Requirement Specification (FRS)

    Definition of requirements to fulfil the demands of the process (from the Users‘s point of view).

  • GMP Guidelines

    Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in...

  • Good Automated Manufacturing Practice (GAMP)

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

  • Gowning Protocols

    Contrary to safety PPE, clothing worn in cleanrooms acts to protect the environment from the wearer....

  • Gowning Qualification

    A program that establishes, both initially and on a periodic basis, the capability of an individual...

  • Grade 304 Stainless Steel

    Approximate Composition – 18% chromium, 8% nickel (exact composition ranges vary between EN and ASTM...

  • Grade 316 Stainless Steel

    Approximate Composition – 17% chromium, 10% nickel, 2% molybdenum (exact composition ranges vary bet...

  • Grade A air

    Air which is passed through a filter qualified as capable of producing grade A non-viable quality ai...

  • GRP

    Glass reinforced polyester

  • Hardwall cleanroom panels

    Hardwall panels are robust, with a high resistance to alcohol and solvents.

  • HEPA filter test

    See DOP testing

  • HEPA filtration

    A HEPA filter is a filter media which is efficient at removing submicron particles from the air.

  • Humidity Control

    Humidity is the concentration of water vapour in the air. When working with advanced materials, the...

  • HVAC

    HVAC is an acronym for Heating, Ventilation and Air Conditioning, so it relates to air handling.

  • Hybrid

    A hybrid cleanroom is often used to define a cleanroom which uses more than one envelope constructio...

  • Industry 4.0

    Industry 4.0 is the 4th industrial revolution - the digital transformation.

  • Integral Benching

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

  • IQ – Installation Qualification

    Evaluate and confirm that the installed cleanroom is consistent with what was specified.

  • Isolator

    A decontaminated unit supplied with grade A (ISO 5) or higher air quality that provides uncompromise...

  • Laminar flow cabinets

    Vertical laminar flow cabinets / booths create either a localised clean environment or additional pr...

  • LED Lighting

    LED light fittings can be optimised to support minimum working plane Lux requirements.

  • Low level exhaust vent

    A low level exhaust vent is an outlet at the bottom of a cleanroom where particles are flushed out d...

  • LPM

    LPM is an abbreviation of litres per minute (l/min). When used in the context of a particle counter'...

  • Lux levels

    Typically, the minimum lux requirements for a cleanroom are driven by the production of small and se...

  • Magnehelic Pressure Gauge

    Magnehelic differential pressure gauges are provided to ensure a positive pressure boundary is maint...

  • MHRA - Medicines and Healthcare products Regulatory Agency

    The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blo...

  • Micron

    A micron is one thousandth of a millimetre.

  • Modular cleanroom

    Modular cleanrooms are freestanding structures that can withstand the high volume of airflow require...

  • Monobloc cleanroom system

    Monobloc cleanroom systems feature flush-fitting wall panels for reduced particle retention and supe...

  • NADCAP

    Nadcap (National Aerospace and Defense Contractors Accreditation Program) is aimed at generating a c...

  • Occupancy states

    As-built - condition where the cleanroom or clean zone is complete with all services connected and f...

  • Offsite Cleanroom Construction

    Off-site construction offers a more accurate and timely installation with less chance of failure, wi...

  • Opaque Panel

    Opaque hardwall cleanroom panels provide a good resistance to alcohol and solvents and give a bright...

  • Operational cleanroom

    A cleanroom that is complete, functional and ready for operation, with the equipment and personnel i...

  • Operator

    Any individual participating in the aseptic processing operation, including line set-up, filler, mai...

  • OQ – Operational Qualification for Cleanrooms

    Verify that the cleanroom equipment is achieving the operational parameters specified.

  • Overkill sterilization process

    A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minim...

  • Panel System Cleanroom

    Monobloc cleanroom systems feature flush-fitting wall panels for reduced particle retention and supe...

  • Pass through hatch

    A small room with interlocked doors, constructed to maintain air pressure control between adjoining...

  • Pharmaceutical Quality System (PQS)

    Highlights the specific requirements of the PQS when applied to sterile medicinal products.

  • Powder coated steel

    Mild steel box section is applied with a polyester powder coating. This provides a very even, semi-g...

  • PQ - Performance Qualification

    Challenge that the cleanroom equipment is performing together in an operational state.

  • Pressure cascade

    Pressure cascades with a cleanroom environment ensure that the flow of contamination is from clean t...

  • Pressure differential

    A pressure differential is a difference of pressure between points in a process system. They are use...

  • Qualification

    Establishing documented evidence that provides a high degree of assurance that equipment or faciliti...

  • Rapid roller door

    Rapid roll doors are effective at providing a large opening into a cleanroom for goods in/out.

  • Restricted Access Barrier System (RABS)

    A restricted access barrier system (RABS) provides an enclosed, but not closed, environment meeting...

  • Rotational cleaning

    To control the bioburden in your cleanroom you will need to use disinfectants; these are chemicals t...

  • Sanitation

    The documented written program of cleaning and disinfecting the cleanroom surface.

  • Sigma (∑) column of particle counts

    Particle counters display readings in two columns: cumulative (often depicted by ∑ sigma) and differ...

  • Single leaf swing door

    With a depth of just 50mm, this compact steel door and frame is designed for use in slim line partit...

  • Single Use Systems (SUS)

    Systems in which some product contact components are used only once (i.e. single use components) to...

  • Sliding door

    Sliding doors are produced using controlled manufacturing processes and corrosion inhibiting steel...

  • Softwall cleanroom panels

    Available in a variety of options, our softwall panels provide an economical, effective and durable...

  • Sporicide

    A sporicide is a disinfectant that is effective against spores.

  • Static Electricity

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

  • Sterile Product

    For purposes of this guidance, sterile product refers to one or more of the elements exposed to asep...

  • Sterilizing grade filter

    A filter that, when appropriately validated, will remove a defined 2222 microbial challenge from a f...

  • SteriShield Delivery System

    Ecolab’s SteriShield Delivery System’s (SDS) unique combination of bag in the bottle design and pate...

  • Temperature & humidity control

    Particle control and temperature and humidity performance need to be balanced in order to create a r...

  • Terminal sterilization

    The application of a lethal sterilizing agent to finished product within a sealed container to achie...

  • The Federal Standard 209E

    The Federal Standard 209E "Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones" gr...

  • ULPA Filtration

    An ULPA filter is a filter media which is efficient at removing submicron particles from the air. It...

  • Unidirectional flow

    An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed, to...

  • User Requirement Specification (URS)

    Definition of requirements to fulfil the demands of the process (from the Users‘ point of view).

  • UV Lighting

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

  • Validation

    Establishing documented evidence that provides a high degree of assurance that a specific process wi...

  • Vaporised Hydrogen Peroxide (VHP)

    Vaporised hydrogen peroxide (VHP) has antimicrobial properties and so has decontamination and steril...

  • Vent Protectors

    A vent protector can stop any large object entering the cleanroom.

  • Water for Injection (WFI)

    Water for Injections contains water that has been cleaned and purified so there are no chemicals, ba...

  • Water for Irrigation (WFI)

    Sterile, distilled and nonpyrogenic water usually presented in plastic bottles.

  • Worst case

    A set of conditions encompassing upper and lower processing limits and circumstances, including thos...

We hope you enjoyed using our Cleanroom Glossary, we will continue to populate the Glossary with more interesting cleanroom information. Please visit us again.


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