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...

  • 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 accomodation requ...

  • At-rest cleanroom

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

  • 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...

  • 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...

  • Cleanroom

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

  • Cleanroom Energy Standard BS 8568:2013

    BS 8568:2013 is a code of practice for improving energy efficiency in cleanrooms and clean air devic...

  • 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.

  • 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 that has been purified to a level where its ions have been removed, but not as much as WFI.

  • 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).

  • 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

    Proof that your cleanroom is capable of compliance with regulatory and process needs.

  • ECO Cleanroom Control

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

  • 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...

  • 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...

  • GMP Guidelines

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

  • 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...

  • 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.

  • HVAC

    See Temperature & humidity control

  • 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 metres per minute (m/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 s...

  • 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...

  • 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...

  • 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.

  • 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...

  • 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...

  • 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 that is produced to the highest level of purity that it is used in solutions that could be obj...

  • Worst case

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

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