Glossar

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.

  • 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...

  • 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 or more component parts to create a material with specialist properties to s...

  • 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...

  • 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...

  • 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.

  • 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...

  • 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...

  • OQ – Operational Qualification for Cleanrooms

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

  • Panel System Cleanroom

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

  • 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...

  • Rapid roller door

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

  • 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...

  • 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.

  • 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...

  • ULPA Filtration

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

  • UV Lighting

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

  • 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.

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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