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.
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Cleanroom Air Conditioning
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An established microbial or airborne particle level that, when exceeded, should trigger appropriate...
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An actuator is a mechanical component that can move a mechanism or system.
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Feet that can be adjusted to ensure a level system is created, even on uneven floors.
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Advisory Committee on Dangerous Pathogens
The Advisory Committee on Dangerous Pathogens' (ACDP) role is to provide scientific advice on the ri...
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The amount of time a cleanroom can completely replace its air volume within an hour.
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With regards to cleanrooms, air cleanliness is usually measured by taking airborne particle counts w...
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See temperature and humidity control
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Air differential
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Connect 2 Cleanrooms support the implementation of Air Handling Units only in certain circumstances.
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A small room with interlocked doors, constructed to maintain air pressure control between adjoining...
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Airborne particle counts are an air sampling method, used to determine if a cleanroom is meeting the...
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Airborne particles are sub-micron particles, which are invisible to the naked eye.
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An established microbial or airborne particle level giving early warning of potential drift from nor...
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The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, par...
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Approved Code of Practise (ACOPs)
ACOPs describe preferred or recommended methods that can be used (or standards to be met) to comply...
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A cleanroom that is complete, functional and ready for operation, but without the equipment and pers...
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A state of control attained by using an aseptic work area and performing activities in a manner that...
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The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms...
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A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and e...
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A room in which one or more aseptic activities or processes are performed.
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A major benefit of an assisted build is that it can keep costs down, as travel and accommodation req...
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A cleanroom that is complete, functional and ready for operation, with the equipment inside, but wit...
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Bacterial Filtration Efficiency (BFE)
The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that...
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This test is performed to validate that a filter can remove bacteria from a gas or solution.
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A physical partition that affords aseptic processing area (grade A) protection by partially separati...
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Bioburden is the number of bacteria living on an un-sterilised surface. See Rotational Cleaning f...
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Biocidal Products Regulation (BPR)
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market...
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Many biocidal disinfectants have a broad spectrum of activity, especially against bacteria and fungi...
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A population of microorganisms inoculated onto a suitable medium (e.g. solution, container or closur...
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Blow-Fill-Seal (BFS) technology is a pharmaceutical filling process in which containers are formed f...
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Breakout panels should be clearly marked and need to be able to be removed in seconds to allow exit....
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CFM is an abbreviation for cubic feet per minute (cu ft/min). When used in the context of a particle...
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It is good practice for all cleanrooms to include a change area as it helps operatives adhere to gow...
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Clean in Place products and processes - Clean-in-place is a method of cleaning the interior surfaces...
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An area with defined particle and microbiological cleanliness standards.
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Clean Non Classified (CNC) area
An area that does not meet any of the formal pre-determined grades of cleanliness included in the An...
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The removal of soils and residues (including biofilms) through use of a detergent. This should alway...
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A cleanroom is a "room within which the number concentration of airborne particles is controlled.......
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A cleanroom may need to be extended to allow organisations to react to increased market demand.
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There are a number of reasons for which a cleanroom may need to be relocated.
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A system in which the sterile product is not exposed to the surrounding environment.
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CMC is an acronym for Chemistry Manufacturing and Controls, which are stages of the drug development...
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A microbiological term that describes the formation of a single macroscopic colony after the introdu...
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Activities to verify that equipment and systems are installed according to specification
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Any ingredient intended for use in the manufacture of a drug product, including those that may not a...
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A material made up of 2 component parts, typically resin and fibre, used to create strong but lightw...
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When the floor is extended at the edges to be applied up the wall, creating a curved surface from wa...
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An area designed to maintain sterility of sterile materials. Sterilized product, containers, closure...
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Surfaces that may come into contact with, or directly affect, a sterilized product or its containers...
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Particle counters display readings in two columns: cumulative (often depicted by ∑ sigma) and differ...
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The time (in minutes) of exposure at a given temperature that causes a one-log or 90 per cent reduct...
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Through a de-centralised air handling approach, the same results can be delivered as with an AHU, bu...
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De-ionised water (DI water of DIW)
Deionized water is water that has had almost all of its mineral ions removed, however deionization d...
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A process that eliminates viable bioburden via use of chemical agents.
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Delta (∆) column of particle counts
Particle counters display readings in two columns: differential (often depicted by ∆ delta) and cumu...
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A process used to destroy or remove pyrogens (e.g. endotoxin).
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Dew point (dp) is the temperature that a volume of air reaches when it becomes saturated with water...
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Dewpoint (dp) is the temperature that a volume of air reaches when it becomes saturated with water v...
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Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative...
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The process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection a...
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Interlocked doors support good cleanroom entry and exit practices by only allowing one door to open...
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Dispersed Oil Particulate (DOP) testing, is the process in which the integrity of your HEPA (High Ef...
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Design Qualification (DQ) is the documented verification that the proposed design of the facilities,...
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Environmental monitoring of controls such as pressure differential, particle counts, temperature & h...
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European Medicines Agency. European Union agencies network
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A pyrogenic product (e.g. lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead...
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For cleanroom environments where electrostatic charge is a process risk, static dissipative clear pa...
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A fan filter unit is a motorised unit which supplies clean, filtered air to a cleanroom.
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FDA - Food and Drugs Administration
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department...
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Federal standards for cleanrooms
Now defunct, the U.S. Federal Standard 209E Cleanroom Standards were the U.S. General Service Admini...
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A high risk area in pharmaceutical manufacture, for sterile filling.
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See DOP testing
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The main cleanroom flooring options are loose lay flooring and vinyl flooring.
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The flow rate of a particle counter is the speed in which air is drawn through the sample probe. For...
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Functional Design Specification (FDS)
Specification in which the demands of the manufacturer are transferred into a technical solution (fr...
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Functional Requirement Specification (FRS)
Definition of requirements to fulfil the demands of the process (from the Users‘s point of view).
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Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in...
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Good Automated Manufacturing Practice (GAMP)
A guide for the validation of automated systems in pharmaceutical manufacture.
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Contrary to safety PPE, clothing worn in cleanrooms acts to protect the environment from the wearer....
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A program that establishes, both initially and on a periodic basis, the capability of an individual...
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Approximate Composition – 18% chromium, 8% nickel (exact composition ranges vary between EN and ASTM...
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Approximate Composition – 17% chromium, 10% nickel, 2% molybdenum (exact composition ranges vary bet...
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Air which is passed through a filter qualified as capable of producing grade A non-viable quality ai...
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Glass reinforced polyester
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Hardwall panels are robust, with a high resistance to alcohol and solvents.
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See DOP testing
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A HEPA filter is a filter media which is efficient at removing submicron particles from the air.
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Humidity is the concentration of water vapour in the air. When working with advanced materials, the...
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HVAC is an acronym for Heating, Ventilation and Air Conditioning, so it relates to air handling.
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A hybrid cleanroom is often used to define a cleanroom which uses more than one envelope constructio...
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Industry 4.0 is the 4th industrial revolution - the digital transformation.
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For optimum space utilisation, integrated benching can be installed in cleanrooms.
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IQ – Installation Qualification
Evaluate and confirm that the installed cleanroom is consistent with what was specified.
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A decontaminated unit supplied with grade A (ISO 5) or higher air quality that provides uncompromise...
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Vertical laminar flow cabinets / booths create either a localised clean environment or additional pr...
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LED light fittings can be optimised to support minimum working plane Lux requirements.
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A low level exhaust vent is an outlet at the bottom of a cleanroom where particles are flushed out d...
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LPM is an abbreviation of litres per minute (l/min). When used in the context of a particle counter'...
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Typically, the minimum lux requirements for a cleanroom are driven by the production of small and se...
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Magnehelic differential pressure gauges are provided to ensure a positive pressure boundary is maint...
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MHRA - Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blo...
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A micron is one thousandth of a millimetre.
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Modular cleanrooms are freestanding structures that can withstand the high volume of airflow require...
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Monobloc cleanroom systems feature flush-fitting wall panels for reduced particle retention and supe...
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Nadcap (National Aerospace and Defense Contractors Accreditation Program) is aimed at generating a c...
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As-built - condition where the cleanroom or clean zone is complete with all services connected and f...
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Offsite Cleanroom Construction
Off-site construction offers a more accurate and timely installation with less chance of failure, wi...
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Opaque hardwall cleanroom panels provide a good resistance to alcohol and solvents and give a bright...
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A cleanroom that is complete, functional and ready for operation, with the equipment and personnel i...
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Any individual participating in the aseptic processing operation, including line set-up, filler, mai...
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OQ – Operational Qualification for Cleanrooms
Verify that the cleanroom equipment is achieving the operational parameters specified.
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Overkill sterilization process
A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minim...
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Monobloc cleanroom systems feature flush-fitting wall panels for reduced particle retention and supe...
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A small room with interlocked doors, constructed to maintain air pressure control between adjoining...
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Pharmaceutical Quality System (PQS)
Highlights the specific requirements of the PQS when applied to sterile medicinal products.
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Mild steel box section is applied with a polyester powder coating. This provides a very even, semi-g...
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PQ - Performance Qualification
Challenge that the cleanroom equipment is performing together in an operational state.
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Pressure cascades with a cleanroom environment ensure that the flow of contamination is from clean t...
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A pressure differential is a difference of pressure between points in a process system. They are use...
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Establishing documented evidence that provides a high degree of assurance that equipment or faciliti...
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Rapid roll doors are effective at providing a large opening into a cleanroom for goods in/out.
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Restricted Access Barrier System (RABS)
A restricted access barrier system (RABS) provides an enclosed, but not closed, environment meeting...
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To control the bioburden in your cleanroom you will need to use disinfectants; these are chemicals t...
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The documented written program of cleaning and disinfecting the cleanroom surface.
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Sigma (∑) column of particle counts
Particle counters display readings in two columns: cumulative (often depicted by ∑ sigma) and differ...
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With a depth of just 50mm, this compact steel door and frame is designed for use in slim line partit...
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Systems in which some product contact components are used only once (i.e. single use components) to...
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Sliding doors are produced using controlled manufacturing processes and corrosion inhibiting steel...
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Available in a variety of options, our softwall panels provide an economical, effective and durable...
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A sporicide is a disinfectant that is effective against spores.
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Static electricity is a form of electricity at rest caused by an imbalance at a molecular level with...
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For purposes of this guidance, sterile product refers to one or more of the elements exposed to asep...
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A filter that, when appropriately validated, will remove a defined 2222 microbial challenge from a f...
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Ecolab’s SteriShield Delivery System’s (SDS) unique combination of bag in the bottle design and pate...
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Temperature & humidity control
Particle control and temperature and humidity performance need to be balanced in order to create a r...
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The application of a lethal sterilizing agent to finished product within a sealed container to achie...
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The Federal Standard 209E "Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones" gr...
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An ULPA filter is a filter media which is efficient at removing submicron particles from the air. It...
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An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed, to...
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User Requirement Specification (URS)
Definition of requirements to fulfil the demands of the process (from the Users‘ point of view).
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To supplement standard cleanroom lighting, UV lamps and UV light equipment can be used for both insp...
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Establishing documented evidence that provides a high degree of assurance that a specific process wi...
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Vaporised Hydrogen Peroxide (VHP)
Vaporised hydrogen peroxide (VHP) has antimicrobial properties and so has decontamination and steril...
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A vent protector can stop any large object entering the cleanroom.
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Water for Injections contains water that has been cleaned and purified so there are no chemicals, ba...
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Sterile, distilled and nonpyrogenic water usually presented in plastic bottles.
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A set of conditions encompassing upper and lower processing limits and circumstances, including thos...
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