Cleanroom Das Reinraum Wiki: Begriffe und Definitionen

Welcome to the Cleanroom Wiki, the wiki for terms related to cleanroom technology.

This service of COLANDIS GmbH was created to provide companies from the industry and technology sector with a central contact point for the technical area in cleanroom technology.

We will regularly explain new terms related to cleanroom, cleanliness suitability and cleanroom suitability. Have fun browsing, looking up and informing.

acceptance test (acceptance, qualification)

qualitative and quantitative verification of the specified parameters and/or acceptance criteria of an ME at the intended place of use prior to commissioning (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

ACC filter

Device dedicated to the removal of gaseous (molecular) contamination from the air.

Note 1: Its functioning is based on physical or chemical mechanisms.

Note 2: The following terms are also common: adsorber, molecular filter, gas-phase filter, chemical filter.

(VDI 2083: Blatt 8.1: 2014-10 Düsseldorf)

Acid

Species whose chemical reaction characteristic is to establish new bonds by the acceptance of electron pairs (ISO 14644-8: 2003-09)

Substance whose chemical reaction characteristic is to establish new bonds by the acceptance of electron pairs. (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Acid capacity (KS)

Quantity of hydrogen ions (H₃O⁺) that a certain volume of water can accommodate until reaching a predefined of water can accommodate until reaching a predefined pH-value. In water, this is primarily the effect of hydrogen-carbonate and carbonate ions. With regard to the titration curve of carbonic acid, the final pH-values are specified to be 8,2 and 4,3: acid capacity up to pH-value 8,2 (K_S8,2), acid capacity up to pH-value 4,3 (K_S4,3; formerly carbonate hardness or m-value). (as defined in DIN 4046)

Note: Obsolete term: m-value

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Action level

Level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including the investigation of cause, and corrective action. (EN ISO 14644-7) (VDI 2083: Blatt 3.1: 2012-06 Düsseldorf)

Active minienvironment

A minienvironment that creates and maintains a controlled condition. (SEMI E44-96, Guide for Procurement and acceptance of minienvironments, 1995)

ME which creates special process conditions by active ventilation through HEPA and/or AMC filters or by means of an inert gas flow (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Activity

Effective concentration of atoms, ions and molecules. It is the measure of concentration to be entered in the laws derived for ideal mixtures and solutions (such as the law of mass action) so that they can even be applied when the behaviour in the respective system is no longer ideal. It is expressed in terms of the activity coefficient. (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Adapted minienvironment

A minienvironment which can be removed from the process tool without restricting the tool’s wafer loading/unloading and processing functions. Tools may have provisions for input/output interface, power and interlock communications. (SEMI E44-96, Guide for Procurement and acceptance of minienvironments, 1995)

ME which is not permanently connected to the production facility, which is thus removable, and which can (but does not necessarily) contain components for the supply of conditioned air (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Adapted SMIF

A unit including a SMIF port and a cassette transfer mechanism. The unit can be removed from the process tool without restricting the tool’s loading/unloading function. (SEMI E44-96, Guide for Procurement and acceptance of minienvironments, 1995)

Aerosol generator

"instrument capable of generating particulate
matter having appropriate size range (e.g.
0,05 μm to 2 μm) at a constant concentration,
which may be produced by thermal, hydraulic,
pneumatic, acoustic, or electrostatic means"

(EN ISO 14644-6:2007)

Agar

A dried substance of algar origin having the property of melting at 100°C and solidifying into a gel at 40°C . Agar is not normally digested by most bacteria and is used as a medium in the preparation of solid cultures of microorganisms. (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Airborne molecular contamination (AMC)

Presence in the atmosphere of a cleanroom or controlled environment of molecular (chemical, non-particulate) species in the gaseous or vapour state, which may have a deleterious effect on the product, process or equipment in the cleanroom or controlled environment

NOTE. This definition does not include biomolecules, which are judged to be particulates.

(ISO 14644-8: 2003-09)

Air changes

A value indicating the number of times per hour that the air is changed within a certain room or containment. A very commonly used indicator for conventional cleanroom that purge themselves. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Air changes

Airlock

Intermediate room that is normally ventilated. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Intermediate room that is normally ventilated, and used to minimize the transfer of airborne contaminants from one area to another (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Air velocity

A value indicating the speed of the air movement in a room. A very commonly used indicator of the ability of a unidirectional-flow cleanroom that purge itself. (Introduction to Contamination Control and Cleanroom Technology, 1999)

A value indicating the speed of the air movement in a room or a zone in the room. A very commonly used indicator of the ability of a unidirectional-flow cleanroom that purge itself. (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Alcohol

Any of a class of organic substance formed from hydrocarbons by the substitution of one or more hydrogen atoms with en equal number of hydroxyl groups. Alcohols are mainly used as cleaning agents because they can solubilize fats and are potent disinfectants where microorganisms are concerned (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Alert level

Level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, should result in increased attention to the process. (EN ISO 14644-7) (VDI 2083: Blatt 3.1: 2012-06 Düsseldorf)

Algae

A group of cryptogamic plants in which the body is unicellular. This group includes seaweeds and many unicellular fresh water plants, most of which contain chlorophyll. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Alkali

A class of chemicals which from soluble soaps with acids and also form soluble carbonates. These substances are mainly used as cleaning agents due to their ability to dissolve proteins and other organic, material (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

AMC (airborne molecular contamination)

The occurrence of such molecular (chemical, nonparticulate) substances in the gas or vapour phase, within the atmosphere of a cleanroom or controlled environment, as can have a detrimental effect on the product, the process, the equipment or the personnel.

Note: The classification of a substance as AMC is application-specific; this means that the same substance may, or may not, in different applications, be classified as a contamination.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Presence in the atmosphere of a cleanroom or controlled environment of molecular gases or vapours that may have a deleterious effect on humans, the product, process, environment or equipment (adapted from DIN EN ISO 14644-6, 2.12)

Note 1: This definition does not include macromolecules of biological origin, which are judged to be particles [adapted from DIN EN ISO 14 644-6].

Note 2: The AMC classification varies from case to case. Hence, the same substance can be classified or not as a contaminant in different cases (compatibility with the required cleanliness).

According to current standards, “AMC” is no longer used for classifying cleanliness. For this purpose, the airborne cleanliness by chemicals (ACC) as per DIN EN ISO 14 644-8 shall be used.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

AMC filter

Device dedicated to the removal of gaseous (molecular) contamination from the air. Its functioning is based on physical or chemical mechanisms.

Note: The following terms are also common: adsorber, molecular filter, gas-phase filter, chemical filter.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Anderson sampler

Sampling device for the collection of microorganisms based on impaction. The sampler has up to eight stages stacked in series, each stage consisting of a perforated plate. A Petri dish of agar growth medium is placed beneath each plate. Air that is draw into the sampler impacts with the agar of each stage. Air velocity increases at each succeeding stage due to progressively smaller holes causing suspended particles to be distributed among the plates according to size. Larger particles are trapped in the upper stages; smaller particles in the lower stages (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Anisokinetic sampling

The condition of sampling in which the mean velocity of the flowing air stream differs from the mean velocity of the air entering the inlet sampling probe. Because of particle inertia, anisokinetic sampling can cause the concentration of particles in the sample to differ from the concentration of particles in the air being sampled. (Federal Standard FED-STD-209E / 11. September 1992; airborne particulate cleanless classes in cleanrooms and clean zones)

The taking of air samples under conditions in which the velocity and direction of the air entering the sampler are different from the velocity and direction of the air in the room (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

"sampling condition in which the mean velocity of the air entering the sample probe inlet is significantly different from the mean velocity of the unidirectional airflow (2.138) at that location"

(EN ISO 14644-6:2007)

Antistatic

Property of a material having little tendency to electrostatic charging

Note: The limits listed in this standard (resistance, charge, etc.) are but examples and have to be agreed upon between user and supplier for the object in question. For instance, even electrostatic potentials below 10 V can damage or destroy electronic components.

Antistatic properties

The capability to reduce electrostatic charges on the surfaces of the workplace or the product, either to a specified level or to the nominal value, by means of conduction or other mechanism. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

As-built cleanroom (facility)

A cleanroom (facility) that is complete and ready for operation, with all services connected and functional, but without equipment or operating personnel in the facility. (Federal Standard, Stuttgart 1991)

Condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present (ISO 14644-1:1999 (E))

Aseptic filling

Sterile containers are filled with the sterile product and sealed with sterile closures. Frequently used with products that cannot be sterilized at the final stage of production (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Aseptic technique

Techniques that are carried out to avoid infection. In other words aseptic techniques are used to prevent sterile material and/or products from becoming infected. (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

At-rest cleanroom (facility)

A cleanroom (facility) that is complete, with all services functioning and with equipment installed and operable or operating, as specified, but without operating personnel in the facility. (Federal Standard, Stuttgart 1991)

Condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present (ISO 14644-1:1999 (E))

Autoclave

An apparatus for effecting sterilization by steam under pressure, fitted with a gauge that automatically regulates the pressure and therefore the degree of heat to which the contents are subjected (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Background

Outgassing rate of the vacuum chamber under normal conditions of operation at a certain mass range and time in the absence of the part to be verified. (ASML-Standards, Cleanliness Grades, Grade 2: Verification RGA, GSA 07 2211,2008)

Barrier class

The barrier classes are based on the protective effect to be afforded by the clean environment. Depending on the application, they are either

-person-related,

-product-related,

-environment-related or

-combinations of the above,

Base

Species whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs (ISO 14644-8: 2003-09)

Substance whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs. (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Base capacity (KB)

Quality of hydroxide ions (HO^–) that a certain volume of water can accommodate until reaching a predefined pH-value. The final pH-values defined are the same as for the acid capacity:

base capacity up to pH-value 8,2 (K_B8,2); formerly “free carbonic acid”), base capacity up to pH-value 4,3 (K_B4,3, formerly negative m-value). (as defined in DIN 4046)

Note: Obsolete term: p-value

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Biocontamination (biological contamination)

Biocontaminations may be particulate (bacteria, viruses, etc.) or molecular (endotoxins, etc.).

Note: In the context of this guideline, medical or specific characteristics of biocontamination are not addressed unless these characteristics concern matters of general product protection/personal protection. Also, the guideline only deals with such characteristics as concern the respective categories, rather than considering characteristics of specific biological entities, provided this is not required for assessing the hazard potential (see also VDI 2083 Part 18)

(VDI 2083: Blatt 16.1: 2010-08 Düsseldorf)

Contamination of raw materials, equipment, personnel, surfaces, liquids, gases or air with viable particles. (VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Biofilm (bacterial lawn)

Film-like growth of microorganisms held together by a matrix of extracellular polymeric substances (EPS). Biofilms form primarily in the aqueous phase. They can form and grow at any aqueous-phase interface. (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Biofouling (biological fouling)

Deposits on surfaces due to microbial growth (bacteria, algae, moulds) and to biofilm formation. May lead to corrosion and material damage.

Note: See also fouling of membranes (Section 3.3) and fouling of ion exchangers (Section 3.4).

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Biological agents

Microorganisms, including those which have been genetically modified, cell cultures and human endoparasites which may be able to provoke any infection, allergy or toxicity.

(in accordance with the Council Directive 90/679/EEC)

(VDI 2083: Blatt 12: 2000-01 Düsseldorf)

Biosafety cabinet

Contaminate device for protection of operations and workers from hazardous microorganisms and in some cases for protecting the work area from contaminants from the outer environment (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Biotoxic

Contaminant species that is obnoxious to the development and preservation of the life of organisms, microorganisms, tissues or individual cells (ISO 14644-8: 2003-09)

"contaminant (2.41) substance that is obnoxious to the development and preservation of the life of organisms, microorganisms, tissues or individual cells"

(EN ISO 14644-6:2007)

Calibration

Comparison of a measurement standard or instrument of unknown accuracy (Federal Standard, Stuttgart 1991)

Determination of the accuracy of an invariation from a standard, to a certain necessary correction factor. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Comparison of a measurement standard or instrument of unknow accuracy with another standard or instrument of know accuracy to detect, correlate, report, or eliminate by adjustment any variation in the accuracy of the unknown standard or instrument. (Federal Standard FED-STD-209E / 11. September 1992; airborne particulate cleanless classes in cleanrooms and clean zones)

Capacity

The mass of a specific substance (AMC) taken up by a filter before a specified breakthrough occurs.

Note 1: The capacity is a characteristic of AMC filters which depends on the concentration and the operating conditions.

Note 2: The total capacity is the mass of a specific substance (AMC) for 100% breakthrough.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Cascade Impactor

"sampling device, which collects particles from an aerosol using the principle of impaction
upon a series of collector surfaces

NOTE Each successive collector surface is
exposed to an aerosol stream flowing at a higher
velocity than was the previous one, thus allowing collection of smaller particles than the previous one."

(EN ISO 14644-6:2007)

Centrifugal air sampler

A sampling device used for the collection of microorganisms suspended in air, based on impaction. The impaction force is obtained with a rotating fan which forces particles in the onto an agar plate (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Changing room

Room where people using a cleanroom may change into or out of cleanroom clothing. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Room where people using a cleanroom may change into, or out of, cleanroom apparel (ISO 14644-4:2001 (E))

"room where people entering or leaving a cleanroom put on or take off cleanroom clothing

NOTE: Adapted from ISO 14644-4:2001, 3.1., and ISO 14644-5:2004, 3.1.2."

(EN ISO 14644-6:2007)

Chemical contamination

(molecular contamination)

Undesirable perceivable molecular modification of substances and their contamination or degradation, caused by contaminations, regardless of the contamination path (e.g. from the gas phase, as a particle, as a germ).

(VDI 2083: Blatt 8.1: 2014-10 Düsseldorf)

Undesirable and perceptible chemical change, or contamination (3.1) or destruction, of substances caused by contaminants (3.4), regardless of how the contamination is carried in (from the gaseous phase, as a particle (3.2) or germ, etc.). (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Chemical-mechanical polishing (CMP)

Planarization of structures on a wafer surface by the action of mechanical forces and simultaneous chemical action of the oxidant.

Note: The process uses polishing slurries and abrasives.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Chemical resistance

Resistance to the effects of chemicals (e.g. cleaning agents and disinfectants)

Note 1: The outer appearance can change.

Note 2: “Chemical resistance” is not to be mistaken in this case for the PPE requirements regarding chemical protection.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Chemical resistance generally describes the durability of materials (3.1) under the influence of chemicals/substances (such as cleaning agents and disinfectants).

Note 1: Changes in appearance of material are possible.

Note 2: An aspect of chemical resistance referring to matals is corrosion (3.6).

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Chemisorption

The removal of specific substances (here: ->AMC) by way of physical adsorption and subsequent chemical reaction. The chemical reaction is, as a rule effected by a reactive agent with which the adsorbent has been impregnated (cf. ->physiorption).

Note: Unlike physisorption, chemisorption is mostly irreversible.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Classification

Level (or the process of specifying or determining the level) of airborne particulate cleanliness applicable to a cleanroom or clean zone, expressed in terms of an ISO Class N, which represents maximum allowable concentrations (in particles per cubic metre of air) for considered sizes of particles

NOTE 1 The concentrations are determined by using equation (1)

NOTE 2 Classification in accordance with this International Standard is limited to the range extending from ISO Class 1 through ISO Class 9.

NOTE 3 The considered particle sizes (lower threshold values) applicable for classification in accordance with this International Standard are limited to the range from 0,1 µm through 5 µm. Air cleanliness may be described and specified (but not classified) in terms of U descriptors or M descriptors (see 2.3.1 or 2.3.2) for considered threshold particle sizes that are outside of the range covered by classification.

NOTE 4 Intermediate ISO classification numbers may be specified, with 0,1 the smallest permitted increment; i.e., the range of intermediate ISO classes extends from ISO Class 1,1 through ISO Class 8,9.

NOTE 5 Classification may be specified or accomplished in any of three occupancy states

(ISO 14644-1:1999 (E))

Distinction of classes of air cleanliness by defining limits. The limit of a class is the maximum permissible particle concentration for a specified particle size (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

Distinction of airborne particulate cleanliness according to class limits. The class limit is the maximum permissible particle concentration at a specified particle size (VDI 2083 Part 1). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Rating of the particle emission from materials (3.1) under frictional load based on nationally and internationally established air cleanliness classes (such as VDI 2083 Part 1, DIN EN ISO 14644-1). (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Clean area(s)

Zones in which the concentration of airborne particles is controlled to meet a specified cleanless class according to part 1 of this Guideline. (VDI 2083: Blatt 4: 1996 Düsseldorf)

Area within a room, an installation, or a machine, where the condition are specified as for a cleanroom, and which may be enclosed by a further area (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

Cleaning

Removal of contamination (ASML-Standards, Cleanliness Grades Grade 2: Surface Cleanliness, GSA 07 2310, 2007)

Cleaning for the purpose of this Guideline is the removal of particulate contamination affecting product or process. (VDI 2083: Blatt 4: 1996 Düsseldorf)

For the purposes of this guideline, the term “cleaning” denotes the targeted removal of particulate contaminations affecting the product or the process. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Targeted removal of contaminants from a surface (ISO 14698-3). (VDI 2083: Blatt 5.1: 2007-09 Düsseldorf)

Cleaning is the targeted removal of visible particle and other contamination.

Note: The effectiveness is assassed visually, using optical means, if required. This assessment is qualitative.

(VDI 2083: Blatt 16.1: 2010-08 Düsseldorf)

targeted reduction of impurities to a defined level

Note: Effectiveness is established according to specified procedures. As a rule, these are qualitative procedures.

(VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Dedicated removal of contaminations (3.1) interfering with the product or the process. (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Removal of contamination from an area or an object to the extent required for further processing and for the intended use. (VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Cleanliness

Condition of a product, surface, device, gas, fluid, etc. with a defined level of contamination

NOTE Contamination can be particulate, non-particulate, biological, molecular or of other consistency.

(ISO 14644-4:2001 (E))

Air cleanliness at the work place is particulate cleanliness, i.e. the absence of disturbing airborne contamination (particles) which appear as dust, mist or microorganisms. The measure of this cleanliness is the particulate concentration per volume unit.

Non-particulate cleanliness of gases and ions (electrical fields) has be differentiated from this.

(VDI 2083: Blatt 2: 1996-02 Düsseldorf)

Cleanliness level

An established maximum allowable amount of contamination in a given area or volume, or on a component. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Cleanliness suitability

Cleanliness suitability tests on operation materials are concerned with all contamination factors (see Annex A). Product-specific cleanliness requirements form the basis for assessing form the basis for assessing the cleanliness suitability of an operating material.

(VDI 2083: Blatt 8: 2000-08 E; Düsseldorf)

Cleanliness suitability tests on operation materials are concerned with all contamination factors Product-specific cleanliness requirements form the basis for assessing form the basis for assessing the cleanliness suitability of an operating material.

(VDI 2083: Blatt 8: 2002-09 Düsseldorf)

Cleanroom

A room in which the concentration of airborne particles is controlled and which contains one or more clean zones. (Federal Standard, Stuttgart 1991)

Room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary (ISO 14644-1:1999 (E))

Room with a defined concentration of airborne particles, so designed and used as to minimise the number of particles carried into, or generated in, the room, and deposited in the room, and where other parameters relevant to cleanliness, such as temperature, humidity, and pressure are controlled as required (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

Room in which a specified limit for the concentration of airborne, and other forms of, contamination is observed.

Note: A controlled environment may be open or enclosed and may lie within or outside of a cleanroom.

(VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

A room in which the concentration of airborne particles is controlled to a certain level. Control of cleanliness in such a room in often achieved by controlling the introduction, formation and retention of particles in the room. In many cases there is also a need to control temperature, pressure and humidity (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

"room in which the concentration of airborne
particles is controlled, and which is
constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary"

(EN ISO 14644-6:2007)

Cleanroom compatibility

Cleanroom compatibility serves to assess the suitability of a piece of equipment for use in cleanrooms specified in accordance with a technical rule for assessing the air cleanliness. For the purposes of this guideline, the classification is based on the particle emission. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

criterion for the assessment of the suitability of a piece of equipment for use in cleanrooms specified in accordance with technical in rule for assessing the air cleanliness

Note 1: For the purposes of this standard, the classification is based on the particle emission.

Note 2: Cleanroom compatibility is included in the compatibility with the required cleanliness.

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Evaluation of consumables in terms of the compatibility with cleanrooms based on the release of particulate contaminants Note: Cleanroom compatibility is part of compatibility with the required cleanliness. Regarding the cleanroom compatibility of equipment/compatibility of equipment with the required cleanliness, see Figure 1 as well as VDI 2083 Part 9.1 and Part 17.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Cleanroom installation

Cleanroom or one or several controlled environments together with all associated buildings, air-conditioning systems, connections and utilities (ISO 14644-1:1999, 2.1.3). (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Cleanroom protocol

The cleanroom protocol includes activities during the realisation of a cleanroom project, which serve to maintain a defined level of cleanliness during the construction stage in question; examples are cleanroom apparel, behaviour, the entering of personnel and materials, cleaning and clean assembly. (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Cleanroom suitability

Cleanroom suitability assesses the suitability of an operating material for use in cleanrooms which have been specified in accordance with a regulating body for assessing air cleanliness. The classification criterion in this instance is the emission of particles from the operation material. Cleanroom suitability is an integral part of cleanliness suitability.

The tests must be carried out in cleanrooms with unidirectional airflows (prevention of cross-contamination).

No other particle sources may influence the test whilst measurements are being performed. The exclusion of foreign particles ensures that only particles emitted from the operating material are detected. Before carrying out measurements, the person concerned must first perform qualitative measurements at the measuring site using random samples without the operating material being present. In this way, no other particle sources should be able to influence the measurements obtained during the classification measurements. The operating material must first be decontaminated using suitable cleaning techniques before it is introduced into the cleanroom (see VDI 2083 Part 4).

(VDI 2083: Blatt 8: 2000-08 E; Düsseldorf)

(VDI 2083: Blatt 8: 2002-09 Düsseldorf)

Cleanroom suitability of materials

Suitability of materials for use in cleanrooms based on an evaluation of their emission of particulate contaminations (3.1) (particles 3.2).

Note: All contamination criteria relevant to the product in question are taken into consideration.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Cleanroom technology

That area of contamination control which utilizes cleanrooms. Cleanroom technology also includes all the different actions and precautions taken in order to create a working environment in which the level of contamination is controlled (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Cleanwork place

A controlled area with a cleanliness level corresponding to the air cleanliness classes as specified in Part 1

The personnel can stay either with the clean work place (cleanroom) or outside (e.g. clean work bench or clean cabin).

Different types of clean work places can be distinguished by size and constructional demarcation, e.g.:

-cleanroom (personal is working within the room);

-clean cabin (personal only opens the all-enclosed cabin if required);

-cleanroom tent (clean area enclosed by foil)

(VDI 2083: Blatt 2: 1996-02 Düsseldorf)

Clean zone

A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness. (Federal Standard, Stuttgart 1991)

Dedicated space in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary

NOTE This zone may be open or enclosed and may or may not be located within a cleanroom

(ISO 14644-1:1999 (E))

Collected volatile condensable material (CVCM)

The mass that outgasses from a material and subsequently condenses on a collector surface as specified in ASTM E 595 expressed as a percentage of the initial specimen mass. See also Total Mass Loss. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Colloid (colloidal system)

Heterogeneous substance consisting of a liquid (dispersion medium) in which ultramicroscopic (1nm to 100nm) particles are suspended evenly because of their electrical charges. They exhibit Brownian motion and are subject to cataphoresis. (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Colony-forming unit (cfu)

Unit for expressing the number of culturable microorganisms. [DIN EN 13098]

Note 1: A colony-forming unit may be formed by one microorganism, a clump of microorganisms or a large number of microorganisms adhering to a particle. [DIN EN 13098]

Note 2: The number of colonies formed can depend on the culture conditions. [DIN EN 13098]

(VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Compatibility of materials with the required cleanliness

Suitability of materials (3.1) for use in clean production environments, established by evaluation.

Note: All contamination criteria relevant to the product in question are taken into consideration.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Compatibility with the required cleanliness

Compatibility with the required cleanliness serves to assess pieces of equipment or air-handling components in view of their use in cleanrooms. It describes the generation or existence of the contamination generated by, or existing on, the piece of equipment or air-handling component. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Criterion for the assessment of pieces of equipment or air-handling components in view of their use in cleanrooms

Note: The compatibility with the required cleanliness describes the generation or existence of the contamination generated by, or existing on, the piece of equipment or air-handling component.

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Evaluation of consumables in terms of the compatibility with controlled production environments

Note 1: All contamination criteria relevant to the product in question are taken into consideration (see also Table 1)

Note 2: Cleanroom compatibility is part of compatibility with the required cleanliness. Regarding the cleanroom compatibility of equipment/compatibility of equipment with the required cleanliness, see Figure 1 as well as VDI 2083 Part 9.1 and Part 17.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Commissioning

Planned and documented series of inspections, adjustments and tests carried out systematically to set the installation into correct technical operation as specified (ISO 14644-4:2001 (E))

Planned and documented series of inspections, adjustments and tests carried out systematically with the aim of commissioning the cleanroom installation in accordance with requirements for specified normal operation. (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Condensable

Species capable of depositing on a surface by condensation, under cleanroom operating conditions (ISO 14644-8: 2003-09)

Substance, which, under cleanroom operation conditions, is capable of depositing on a surface by condensation (see ISO 14644-8). (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

"substance capable of deposting on a surface by condensation under cleanroom operating conditions"

(EN ISO 14644-6:2007)

Condensation nucleus counter (CNC)

An instrument for counting small airborne particles, approximately 0.01 μm and larger, by optically detecting droplets formed by condensation of a vapor upon the particles. (Federal Standard 209D, Stuttgart 1991)

An instrument for counting small airborne particles, approximately 0.01μm and larger in size, by detecting, with optical methods, droplets formed by condensation of vapor on the particles (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

"instrument that is capable of enlarging ultrafine particles by means of condensation for subsequent counting using optical particle
counting techniques"

(EN ISO 14644-6:2007)

Consequential nonconformity

For the purposes of this guideline, consequential nonconformities are deviations from specified quality requirements to be fulfilled by the products or persons to be protected through contamination control while the clean facility is in operation, provided that these deviations can be identified to be contamination-control-related.

Note: These definitions apply to all stage to all stage of design, construction and operation of a clean facility. For instance, even planning and design work not allowing to expect fulfilment of requirements and specifications in accordance with the rules of contamination control, must be considered nonconforming.

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Consumable

Equipment used in cleanrooms or controlled environments and disposed of as intended after single or multiple use

Note 1: Production facilities, equipment for long-term use and powder-like or gaseous and liquid media are not consumables.

Note 2: Consumables for multiple use, e.g. multiple use cleanroom clothing, can be subjected to cleaning cycles.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Contact plate

A small plastic dish overfilled with growth medium so that the level of agar rises above the rim of the plate and used for surface sampling of microorganisms. To take a sample on a flat surface the convex agar surface is firmly pressed against the surface using a gentle rocking motion in order to secure complete contact. (Introduction to Contamination Control and Cleanroom Technology, 1999)

"contact device where the container is a
rigid dish"

(EN ISO 14644-6:2007)

Containment

Something that contaminates. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Technical containment: the use of suitable barriers either to contain as much as possible or to avert the accidental release of biological/chemical agents or ionizing radiation from a closed system (e.g. fermenter, room, building) into the environment. (VDI 2083: Blatt 12: 2000-01 Düsseldorf)

"state achieved by separative devices (2.118) with high degree of separation between operator and operation"

(EN ISO 14644-6:2007)

Contaminant

A specific type of contamination. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

"any particulate, molecular, non-particulate and
biological entity that can adversely affect the
product or process"

(EN ISO 14644-6:2007)

Contaminant category

Group of contaminants (3.4) with similar chemical properties. [adapted from DIN EN ISO 14644-6] (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

"common name for a group of compounds with a specific and similar deleterious effect when
deposited on the surface of interest"

(EN ISO 14644-6:2007)

Contamination

Any particulate or non-particulate, molecular, physical or biological entity having a potential of affecting the product or process (ISO 14644-4). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Any particulate, molecular, non-particulate or biological unit which is capable of exerting a negative influence on the product or process. (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Particulate or non-particulate, chemical, physical or biological entity that can adversely affect the product or process. (adapted from DIN EN ISO 14644-4) (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Contamination Control

Organized action to control the level of (re)contamination during all processes starting after cleaning up to install. (ASML-Standards, Cleanliness Grades Grade 2: Surface Cleanliness, GSA 07 2310, 2007)

Securing an environment in which the number/concentration of airborne particles and or other relevant contaminants of the direct process environment is controlled or minimised (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Any organized action taken to control the level of contamination. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

The overall description of all actions taken in order to gain control of contaminants. Can be used either to product being manufactured or to protect the personnel working in the production, or both (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Corrective action

action to eliminate the cause of a detected nonconformity (International Standard, ISO/FDIS 14001, 2004)

"action to be taken when the results of monitoring indicate that alert levels or
action levels are exceeded"

(EN ISO 14644-6:2007)

Corrosion

Reaction of a metallic material (3.1) with its environment, producing a measurable change of the material, and leading possibly to an impairment od the function of a metal component or entire system.

Note 1: In most cases, this reaction is electrochemical in nature, but in a few cases, it can also be of a chemical or metal-physical character (corrosion as defined in DIN EN ISO 8044).

Note 2: Corrosion is the term used for metallic materials, whereas ageing is used for plastics and lubricants.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Count Median Particle Diameter CMD

"median particle diameter based on the
number of particles

NOTE For the count median, one half of the
particle number is contributed by the particles with a size smaller than the count median size, and one half by particles larger than the count median size."

( EN ISO 14644-6:2007)

Critical area

Confined area in which the product or the process in to be protected from defined contamination.

NOTE: Examples for critical areas are safety benches, SMIF-boxes, isolators and others; openings which cannot be avoided are secured by positive pressure.

(VDI 2083: Blatt 4: 1996 Düsseldorf)

Cross-over bench

See Step-over bench (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

"bench that is used as an aid to changing of
cleanroom clothing and which provides a
barrier to the tracking of floor contamination"

(EN ISO 14644-6:2007)

Decontamination

The freeing of a person or an object of some contaminating substance such as gas, radioactive material, microorganisms etc. Within the area of contamination control decontamination often refers to the reduction of numbers of living organisms to some lower population level, but not necessarily to zero. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Removal of undesirable material down to a specified level (lSO14644-7). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Reduction of contamination to a defined level (see also ISO 14644-7). (VDI 2083: Blatt 5.1: 2007-09 Düsseldorf)

Decontamination is the targeted removal of contamination down to a defined level.

Note: The effectiveness is established qualitatively in accordance with specified procedures.

(VDI 2083: Blatt 16.1: 2010-08 Düsseldorf)

Demonstrated equivalence

The condition where a method of measurement has passed a series of tests to show that it gives equivalent results to those of a standard measurement. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Designated Leak

"maximum allowable penetration, which is
determined by agreement between customer and supplier, through a leak, detectable during scanning of an installation with a discrete-particle counter oraerosol photometer"

(EN ISO 14644-6:2007)

Design qualification (DQ)

The basic design process shall reach closure in a qualification verifying conformance with the requirements as specified in the user requirements specification (URS). The following items shall be verified in particular (see also VDI 2083 Part 3):

cleanroom concept
materials and personnel flow diagrams
machine arrangement drawing
description of installation including design drawing
plans and drawings
incorporation of all agreed additional requirements
interfaces/limits to the scope of supply

(VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Discrete-particle counter (DPC)

An instrument, such as an optical particle counter or a condensation nucleaus counter, capable of resolving responses from individual particles. (Federal Standard 209D, Stuttgart 1991)

An apparatus used for the numerical counting of discrete particles. (Introduction to Contamination Control and Cleanroom Technology, 1999)

"instrument having a means of displaying and
recording the count and size of discrete particles (with a size discrimination) for specific air volume"

(EN ISO 14644-6:2007)

Disinfect

To free from pathogenic organisms, or to render them inert. Within contamination control the word disinfect is often used in order to express the gross elimination of all organisms (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Disinfectant

An agent that disinfects. The term is usually applied to agents used on in animate objects (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Disinfection

Elimination, destruction or deactivation of microorganism on objects or surfaces (see also ISO 14644-5). (VDI 2083: Blatt 5.1: 2007-09 Düsseldorf)

Disinfection is a process aiming to destroy, or irreversibly inactivate, bacteria, fungi and viruses found an and in objects. In the context of this VDI guideline, disinfection is considered to be a count of 1000000 organisms capable of reproduction (socalled colony-forming units -CFUs, germ count), only 10 should be detectable after disinfection. Disinfection is an important measure for discontinuing infection chains.

Note 1: Technically, a distinction is made between disinfection and sterilization. In the case of sterilization. In the case of sterilization, all bacteria, fungi and viruses must be irreversibly inactivated irrespective of the original count.

Note 2: The term disinfection is also used to designate sanitizing, a term common in water and food applications. Both are selective measures that will not destroy all microorganisms (see also sterilization).

Note 3: Note applies to German version only.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Inactivation of all pathogens and a multitude of other microorganisms down to a level adequate to the hygienic use of the facility. [DIN EN 1672-2] (VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Documentation

The results from requalification or testing of each installation to prove continued compliance shall be recorded and submitted as a comprehensive report, along with a statement of compliance or non-compliance with the specified tests. (ISO 14644-2:2000 (E))

Dopant, doping agent

Species which, after sorption, is incorporated in the bulk of a product and is capable of changing the properties of materials, even in trace amounts

NOTE. Typical examples of bulk modifiers in microelectronics are dopants and critical metal contaminants like, e.g. Na, Cu or Fe.

(ISO 14644-8: 2003-09)

Substance which, following -> sorption and/or diffusion, will migrate into the bulk of a product, and which, even as a trace constituent, is capable of modifying the characteristics of materials.

Note 1: Common examples of dopants are compounds of P, B, As, Sb, Ga (see ISO 14644-8).

Note 2: The process of doping can be an intended process step or an undesirable contamination process, e.g. through ->AMC.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Substance which, after adsorption, is incorporated in the bulk of a product and is capable of changing the properties of materials, even in trace amounts.

Note: Typical example of dopants are substances changing the electrical properties of semiconductor materials, e.g. critical metal contaminants such as P, B and As.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Dry heat sterilization

Thermal sterilization at relative humidities less than 100%. It is less efficient than moist heat where the relative humidity is 100% and required longer exposure times at higher temperatures (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

D-value

The decimal reduction time. The D-value is defined as the sterilization time, for a physical or chemical agent, used to obtain a 90% reduction in the number of microorganisms (one log) present in a sample (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Electrical resistance of water

Electrical resistance of water as a measure of the total amount of ions dissolved in the water, unit: Ω cm or M Ω cm.

Note: Electrical resistance is the reciprocal of electrical conductivity.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Electrostatic charging

Difference in potential, generated by friction and separation of materials (triboelectric charging), or by the action of an electric field (electrostatic induction, or influence).

Note 1: The magnitude of the charging potentials depends largely on the tendency of the materials to accumulate charges and on the relative humidity of ambient air.

Note 2: The limits listed in this guideline (resistance, charge, etc.) are but examples and have to be agreed upon between user and supplier for the object in question. Even potentials below 10V can damage or destroy electronic components; this fact should be given consideration in the selection of suitable materials.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Electrostatic discharge (electrostatic dissipation, ESD)

Spontaneous transfer of electrostatic charge between two bodies or materials at different electrostatic potentials

Note 1: An electrostatic discharge occurs through direct contact or is induced by an electrostatic field.

Note 2: Regarding the determination of electrostatically charged materials/material combinations, see SEMI E78-0309.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Spontaneous transfer of charges between two bodies or materials at different electrostatic potentials, caused by direct contact or induced by an electrostatic field.

Note: Electrostatically charged (combinations of) materials can be determined by means of electrostatic-field measurements in accordance with, e.g. SEMI E78-0309)

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Endotoxin

Endotoxins are biochemical substances in the external membrane of Gram-negative bacteria (lipopolysaccharides). Endotoxins are pyrogens and can induce fever when brought into contact with mucosae and when entering the blood of humans and some animals species. Endotoxins are pyrogens and can induce fever when brought into contact with mucosae and when entering the blood of humans and some animal species. Endotoxins are released after cell death and are biologically effective at even the minutest concentrations (lower pg/m range). Unlike the bacteria from which they originate, endotoxins are highly heat-resistant, withstanding even sterilization. (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Entrance plane

A plane perpendicular to the unidirectional airflow located immediately upstream of the region. (Federal Standard 209D, Stuttgart 1991)

A plane perpendicular to the unidirectional airflow located immediately upstream of the region of interest (typically the work area unless otherwise specified) and having the same dimensions an the cross section of the clean zone perpendicular to the direction of the airflow. (Federal Standard FED-STD-209E / 11. September 1992; airborne particulate cleanless classes in cleanrooms and clean zones)

Equipment/ piece of equipment

Equipment includes e.g., the facilities or objects listed hereafter, which are brought into a controlled environment.

This list of examples of pieces of equipment is based on the list given in VDI 2815 Part 5:

-production facilities (such as bonders, assembly equipment, filling stations)

-measuring and testing equipment (such as inspection facilities, microscopes)

-equipment for transport and handling (such as linear axles, conveyor belts, robots)

-storage units (such as boxes, buffers)

-organization tools (such as workpiece carriers

-interior furnishings (such as tables, chairs)

-elements of interior work (such as walls, doors, ceilings, floors)

(VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

facilities or objects listed hereafter, which are brought into a controlled environment:

-production facilities (such as bonders, assembly equipment, filling stations)

-measuring and testing equipment (such as inspection facilities, microscopes)

-equipment for transport and handling (such as linear axles, conveyor belts, robots)

-storage units (such as boxes, buffers)

-organization tools (such as workpiece carriers

-interior furnishings (such as tables, chairs)

-elements of interior work (such as walls, doors, ceilings, floors)

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Equivalent diameter

The diameter of a reference sphere having the same properties and producing the same response in the sensing instrument as the particle being measured (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Facultative anaerobe

Microorganisms which are able to grow under either anaerobic or aerobic conditions (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Fall out plate

A Petri dish containing sterile agar medium used to determine the presence of microorganisms in the air. A fall out plate is placed on a surface and exposed to the surrounding air. Particles suspended in the air will be deposited in the agar as a result of the force of gravity and air movements (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Fermentation

An enzymatic decomposition, especially of carbohydrates as used in the production of alcohol, bread, vinegar and other food or industrial materials (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Fiber

A fiber is defined (ISO 14644) as a particle that has an aspect (length-to-width) ratio of 10 or more (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Filter life

Time of operation of a filter until the maximum permissible passage of residual AMC concentration (protection goal) is reached, or until maximum permissible -> breakthrough.

Note: This definition deviates from the one usual for particle filtration where the filter is defined by the reaching of a maximum permissible pressure drop. The pressure drop across an -> AMC filter, however, is not a function of the filter load.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Fouling of ion exchangers

Accumulation of mainly organic substances, leading to a decrease in efficiency of the ion exchanger. (as defined in DIN 54400)

Note: See also fouling of membranes.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Friction

Dissipation of mechanical energy as relative motion occurs, begins or ends between materials in contact.

Note: Solid-body friction is a specific form of sliding friction, where surface elevations are planed (reshaped and/or removed), which in turn gives rise to the emission of particulate contaminations (3.1).

Sliding friction depends on the magnitude of the normal force, F_N, acting between the surface (3.5) of the material pair, on the coefficient of sliding friction, µ_GL, and the relative velocity, v_rel, of the sliding surfaces rubbing against each other. It is determined by the roughness and material type of the interacting surfaces. The friction coefficient, µGL, is a material-specific quantity, defined as the ratio of frictional force over normal force.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Generation time

The time needed for the act or process of reproduction, e.g. the time needed for one microorganism to divide into two daughter cells (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Germ count

Number of colony-forming units that will form macroscopically countable colonies unter specified condition. (based on DIN 10192-1)

Note: The common unit is the number of colony-forming units (CFUs); the term “colony number” is also in use.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

GMP

Good Manufacturing Practice. A series of rules, used to ensure that the product is always produced in the same way with respect to cleanliness, identity, effect and content. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Ground resistance

Electrical resistance between an electrode placed at an arbitrary point on the surface of a piece of equipment and the groundable point of that piece of equipment, which has a potential of 0 V (mass). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

HACCP

Hazard Analysis Critical Control Point. HACCP is a risk analysis mostly used by the food and beverage industry (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

HAZOP

Hazard and Operability studies of the International Social Security Association. A method for assessing risks (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

HEPA

High Efficiency Particulate Air Filter. A HEPA filter is defined as a filter for ventilation air with the ability to reduce the number of particles of 0.3 µm or greater in size in the air by at least 99.97 % as measured with a DOP aerosol. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Hourly Leak Rate

"ratio of the hourly leakage q of the containment enclosure under normal working conditions (pressure and temperature) to the volume V of the said containment enclosure

NOTE: It is expressed in reciprocal hours (h^-1).

(EN ISO 14644-6:2007)

Impaction

Physical phenomenon taking place when the movement of a particle suspended in a gas is stopped by an obstruction present in the gas stream. When a gas stream is forced towards a solid material, the gas itself will alter direction. Particle suspended in this gas stream, if they have a mass great enough, will not follow the gas stream due to inertia, and will continue in a tangential direction and finally hit the solid material. Impaction is often utilized in apparatus used for the collection of solid contaminants. (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Impingement

Collection of airborne particles in liquids by means of several underlying mechanisms such as impaction, diffusion, interception and sedimentation.

[VDI 4252 Part 3 and VDI 4257 Part 2]

(VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Impinger

Purpose-made gas-washing bottle made of glass or Teflon, serving to sample air constituents. In the impinger, the air is brought into contact with a sampling liquid (solvent or sorption medium) (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Special gas-washing bottle made of glass or Teflon, serving to collect airborne substances. The air is brought into contact with a liquid (solvent or sorption medium). [VDI 2083 Part 8.1] (VDI 2083: Blatt 18: 2012-01 Düsseldorf)

An apparatus used for the collection of contaminants in air and other gases when the gas is forced through liquid in a flask (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Impregnation agent

Substance with which a sorption agent is impregnated in order to allow, by way of chemical reactions (cf. chemisorption) between the impregnation agent and the adsorbed substance, the removed of -> AMC which cannot economically be removed from gas streams by mere physisorption. (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Impregnation agent

Incubation

The process of maintaining warm conditions in which microorganisms or other cells can replicate when provided with appropriate media (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Incubator

An apparatus for maintaining a constant and suitable temperature for the development of eggs, cultures of microorganisms or other living cells (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Increase in salinity

Increase of the salt concentration in treated water compared to raw water as a result of the excess regenerating agents which is indispensable for the regeneration of ion exchangers and the neutralization of the regeneration effluents. (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Inductive charging

Moving conductors carrying art electric current in a static magnetic field, or the variation in time of a magnetic field (B-field) around an electric current which is constant in time and space. will cause induction which may result in a build-up of surface potentials. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Inertia

Inability to move spontaneously. Inertia is used in many sampling techniques and is based on the inability of a particle to be collected due to both mass and speed of movement of the particle (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

In operation

Condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

ready and in operation while producing (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Installation qualification (IQ)

A systematic series of inspections, measurements and tests (and modifications, if necessary) shall be carried out in order to ensure the compliance of each and every part of the cleanroom installation which the design requirements. The following items shall be verified in particular:

inspection and tests for completeness as well as quality in comparison with the specifications given
confirmation of compliance with safety regulations, ergonomic requirements and the relevant regulations and standards
acceptance pf supplier certificates
interfaces between systems and trades
completeness of the cleanroom installation
spare parts package
installation and on-site testing of terminal filters
agreed documentation

(VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Installed filter system

System consisting of filter medium, filter frame and retainer, installed in the ceiling, wall, in a unit or an air duct. (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

"filter system mounted in the ceiling wall, apparatus or duct"

(EN ISO 14644-6:2007)

Installed filter system leakage test

"test performed to confirm that the filters are properly installed by verifying that there is absence of bypass leakage in the installation, and that the filters and the grid system are free of defects and leaks"

(EN ISO 14644-6:2007)

Insulation material

Material with a very limited mobility of charges, as a consequence of which any occurring charges do not dissipate.

Note: For instance, the surface resistance (3.4) of an insulating packaging material as specified in DIN IEC 61 340-1 (VDE 0300-1) has be at least 1 x 10¹¹ Ω ore more under the specified conditions.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Integrated minienvironment

The minienvironments in an integral part of the tool. (SEMI E44-96, Guide for Procurement and acceptance of minienvironments, 1995)

ME which is permanently connected to, or integrated in, the production facility and is thus an inherent part of the production facility (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Internal audit

systematic, independant and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the environmental management system audit criteria set by the organization are fulfilled (International Standard, ISO/FDIS 14001, 2004)

Intrinsic conductivity of water

Electrical conductivity of pure water.

Note: Due to the intrinsic dissociation of water into H₃O⁺ and OH^– -ions which a concentration of 10^-7 mol/ l each (pH=7), at 25°C, the electrical conductivity of pure water is 0,05483 µS/cm (see EN 27888); this corresponds to an electrical resistance of approximately 18,24 M Ω cm.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Isokinetic sampling

The condition of isoaxial sampling in which the mean velocity of the air entering the probe inlet is the same as the mean velocity of the unidirectional airflow at that location. (Federal Standard 209D, Stuttgart 1991)

The condition of isoaxial sampling in which the mean velocity of the air entering the probe inlet is the same as the mean velocity of the unidirectional airflow at the location (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Item

Anything that can be individually described considered, examples including:

– an activity

– a process

– a product

– an organization

– a system

– a person

– a combination of the aforementioned items

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

LAF

Laminar Airflow. A theoretical situation where the air is moving in absolutely parallel streams. In practice very hard to achieve. LAF is not used frequently today. A more accurate term to use is UDF (Unidirectional Flow9. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Lag phase

The early period in the growth pattern of microorganisms when growth or cell division is slow, following inoculation into a culture medium (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

LAL test (Limulus Amebocyte Lysate test)

Test system that determines the coagulation/clotting of amebocyte lysate extracted from the blood of horseshoe crabs (limulus polyphemus) with lipopoly-sacchiarides in the cell walls of Gram-negative bacilli. The test system reacts to as little as 100 to 1000 Gram-negative bacteria per ml; however, it only responds to endotoxin (LPS) released by Gram-negative bacteria. The results are expressed in the international unit EU (endotoxin units). (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Load collective

<tribology> Parameters of input quantities acting on material pair under fictional load.

Note: A load collection is commonly composed of the normal force and the relative velocity between the materials, the duration of load application, and the path lengths covered between the materials (3.1).

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Logarithmic phase

Logarithmic growth phase, the stage of active division in the growth pattern of microorganisms (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Mass Median Particle Diameter MMD

"median particle diameter based on the particle mass.

NOTE: For the mass median, one half of mass of
all particles is contributed by particles with a size smaller than the mass median size, and one half by particles larger than the mass median size.

(EN ISO 14644-6:2007)

M Descriptor

"measured or specified concentration of macroparticles per cubic metre of air, expressed in terms of the equivalent diameter that is characteristic of the measurement method used

NOTE: The M descriptor may be regarded as an upper limit for the averages at sampling locations [or as an upper confidence limit, depending upon the number of sampling locations used to characterize the Cleanroom or clean zone ]. M descriptors cannot be used to define airborne particulate cleanliness classes, but they may be quoted independently or in conjunction with airborne particulate cleanliness classes."

(EN ISO 14644-6:2007)

Membrane methods

For the purpose of this guideline, membrane methods are:

-reverse osmosis (RO)

-ultrafiltration (UF)

-nanofiltration (NF)

-microfiltration (MF)

-continuous electrodeionization (CEDI)

-electrodialysis (ED)

-electrodialysis with polarity reversion (EDR)

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Membrane types

-Anion membrane: membrane selectively permeable for anions (negative ions) while retaining cation

-Cation membrane: membrane selectively permeable for cations (positive ions) while retaining anions

-Composite membrane: membrane consisting of various laminates, a thin separating layer made from various materials

-Symmetric membrane: membrane acting as separating layer throughout its thickness

-Asymmetric membrane: membrane consisting of a thin separating layer and a porous supporting layer

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Micrometer (µm)

A unit of measurement equal to onemillionth of a meter, or approximately thirty-nine millionths of an inch (0,000039 inch), or, 25 microns is approximately 0.001 inch. The micrometer has replaced the micron in the SI system of measurement. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

One thousand of a millimeter, or one millionth of a meter (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Minienvironment (ME)

confined, isolated product environment designed to protect the product against contamination

Note 1: Sources of contamination are, e.g., human beings and other, adjacent processes or process environments.

Note 2: It has proven beneficial to distinguish various ME types (see Figure 2)

Note 3: Transport and storage containers are MEs as defined in this standard. They can be passive or active MEs.

(VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Module types (membrane module types)

The following module types are used in membrane methos:

-spiral-wound module

-hollow-fibre module

-capillary module

-plate module

-tubular module

-cushion module

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Monitoring

"observations made by measurement in accordance with a defined method and plan to provide evidence of the performance of an installation

NOTE: This information may be used to detect trends in operational state and to provide process support."

(EN ISO 14644-6:2007)

Molecule

A particle consisting of at least two identical or different atoms being held together by covalent bonds. Molecules are the smallest parts of compounds still having the properties of the compounds and consisting of stable aggregates of atoms. (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Molecular/chemical contamination

The undesirable and perceivable molecular modification of substances and their contamination of substances and their contamination or degradation, caused by contamination, regardless of the contamination path (e.g. from the gas phase, as a particle, as a germ) (see also ISO 14644-6).

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Monitoring

Immediate systematic recording, observation and checking of measurands, core functions being

data recording,
comparison to specifications; triggering alerts, if required,
representation/visualization, and
data storage/archiving

(VDI 2083: Blatt 3.1: 2012-06 Düsseldorf)

Monitoring

The routine determination of airborne concentrations, as well as the other relevant conditions, in cleanrooms and clean zones. (Federal Standard 209D, Stuttgart 1991)

Observations made by measurement in accordance with a defined method and plan to provide evidence of the performance of an installation

NOTE This information may be used to detect trends in operational state and to provide process support

Routine monitoring of airborne particle concentration and other parameters shall be performed according to a written plan

NOTE Monitoring is normally performed with the installation in the operational state

(ISO 14644-2:2000 (E))

Nonconformity

non-fulfilment of a requirement (International Standard, ISO/FDIS 14001, 2004)

For the purpose of this guideline, nonconformities are, e.g., exceedances of limits given in the contamination control specifications for a facility as agreed between the parties involved. (VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Non-particulate contamination

Non-particulate contamination are precipltates, condensates, filmlike deposits or diffusion products with varying physical states (ionic components, radio-active, reactive materials or allergens, endotoxins, droplets etc.). (VDI 2083: Blatt 4: 1996 Düsseldorf)

Liquid or paste-like, film-like contamination having the potential to affect the process, the product, the personnel or the facilities. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Nonunidirectional airflow

Airflow which does not meet the defintion of unidirectional airflow; previously referred to as “turbulent” or “non-laminar” airflow. (Federal Standard 209D, Stuttgart 1991)

Air distribution where the supply air entering the clean zone mixes with the internal air by means of induction (ISO 14644-4:2001 (E))

Air distribution where the supply air entering the room mixes with the internal air by means of induction. This type of air distribution results in dilution of the concentration of particles and/or other contaminants (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Non-Volatile Residue (NVR)

Material remaining after evaporation of a liquid. Units are determined by the test method used. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Obligate anaerobe

Microorganisms that can grow only in the complete absence of molecular oxygen. Some obligate anaerobe microorganisms are killed by oxygen (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Occupancy state

Occupancy states for cleanrooms (as built, at rest, in operation) are defined in VDI 2083 Part 1. The modes of operation for pieces of equipment shall be agreed. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

States for cleanrooms (as built, at rest, in operation) as defined in DIN EN ISO 14644-1, 4.1)

Note 1: The modes of operation for pieces of equipment shall be agreed.

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

OEL value

OEL values (occupational exposure limits) are limit values for hazardous substances in breathing air, specified to protect occupational health and safety (OHS).

Note 1: Based on OEL values, occupational exposure bands (OEB) or OEL classes can be defined.

Note 2: Figure 2 compares the concentration bands of the OEL-classes to specific barrier techniques.

(VDI 2083: Blatt 16.1: 2010-08 Düsseldorf)

Offline measuring technique

Measuring technique where measured data are transmitted to a master data processing system at regular intervals, with some delay between recording and transmission. (VDI 2083: Blatt 3.1: 2012-06 Düsseldorf)

Operational Cleanroom

A cleanroom or facility in normal operation, with all services functioning and with equipment and personnel, if applicable, present and performing their normal work functions in the facility. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon (ISO 14644-1:1999 (E))

Operational qualification (OQ) or functional qualification (FQ)

A series of tests and measurements shall be carried out in order to ensure the functioning of all parts of the cleanroom installation in such a way as to meet the conditions required for the occupancy states “as built”, and “at rest”. The following items shall be verified in particular:

proper functioning of utilities and auxiliary equipment
calibration of sensors and measuring equipment
testing of open- and closed-loop control systems
confirmation of reserve capacity of the air-conditioning systems
determination of barrier function of the controlled environment, where specified
if necessary, proof and recording of airflow profiles or air change rates as a function of the type of flow
filter leak test
if necessary, verification whether or not the required over- or under-pressure (depending on the purpose of installation) is reached
determination of the particulate air cleanliness class
verification if the requirements concerning temperature and relative humidity can be met
determination of sound pressure, illuminance and type of illumination

(VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Operator inspection

That part of the quality inspection required for quality control which is performed by the operator himself. (DIN 55350-17)

Note 1: “Operator inspection” must be distinguished from “operator control” which is “that part of quality control which is performed by the operator himself”.

Note 2: “Operator inspection” must be distinguished from “self-inspection” and “third-party inspection”, the latter two terms stating whether a quality inspection is performed by the manufacturer or by a different body.

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

organization

Company, corporation, firm, enterprise, authority or institution, or part or combination thereof, whether incorporated or not, public or private, that has its own functions and administration. (International Standard, ISO/FDIS 14001, 2004)

Osmotic pressure

Pressure differential caused by water transport through a semi-permeable membrane that separates two salt solutions of different concentration levels.

Note: In reverse osmosis, the osmotic, pressure must be overcome.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Outgasing

Release of a molecular species in the gaseous or vapour state from a material (ISO 14644-8: 2003-09)

The emission of chemical substances into the gas phase by a material under typical specified cleanroom conditions (temperature, relative humidity and pressure). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

The release of a molecular substance, or of molecular substance, in the gaseous or vapour state, from a material. (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Release of a substance, or of molecular substance, in the gaseous or vapour state, from a material. (VDI 2083: Blatt 8.1: 2014-10 Düsseldorf)

Chemical compounds in the gaseous or vapour state released from a material under typical specified conditions (temperature, relative humidity and pressure)

Note: see also VDI 2083 Part 17

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Overpressure

A term used in a cleanroom if the pressure in the room is higher than in the surrounding envireonment. Overpressure is utilized to reduce the risk of contaminants entering critical environments (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Oxidant

Species which, upon deposition to a product or surface of interest, results in the formation of an oxide (ISO 14644-8: 2003-09)

"substance that, upon deposition onto a surface or product of interest, results in the formation of an oxide (02/03) or participates in a redox reaction"

(EN ISO 14644-6:2007)

Particle

An object of solid or liquid composition, or both, and generally between 0.001 and 1000 µm in size. (Federal Standard 209D, Stuttgart 1991)

Solid or liquid object which, for purposes of classification of air cleanliness, falls within a cumulative distribution that is based upon a threshold (lower limit) size in the range from 0,1 µm to 5 µm (ISO 14644-1:1999 (E))

Minute piece of matter with defined physical boundaries

NOTE For classification purposes refer to ISO 14644-1

(ISO 14644-4:2001 (E))

For the purpose of this Guideline, a particle is a minute piece of matter with defined physical boundaries.

Microorganisms are particles which can multiply under favourable conditions.

Fibres are particles with a length of more than five times the diameter.

(VDI 2083: Blatt 4: 1996 Düsseldorf)

Solid or liquid object with defined physical borders and a particle size of at least 0,1µm, but no more than 5µm (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

Microparticle with defined physical boundaries. (as defined in ISO 14644-5) (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Defined according most standards as an object of solid or liquid composition, or both, of a certain size. US Federal Standard 209 E specifies a size between 0.001 and 1.000µm. ISO 14644 defines a particle as a minute piece of matter with defined physical boundaries (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Particle concentration

The number of individual particles per unit volume of air. (Federal Standard 209D, Stuttgart 1991)

Number of individual particles per unit volume of air (ISO 14644-1:1999 (E))

The number of individual particles per unit volume of air (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Particle emission

Release of particles from a consumable under specified load

Note 1: All emitted particles released during typical use are considered. Therefore, unlike the particle emission behaviour of equipment (VDI 2083 Part 9.1) and materials (VDI 2083 Part 17), the particle emission behaviour of consumables is also influenced by the particle load condition.

Note 2: The following distinction can be made when measuring particle emissions from consumables:

– Immediately prior to the particle emission measurement, the particles are generated due to a typical load.

– Particles have been carried over due to an earlier particle sedimentation process.

– Surfaces from which particles are emitted have not been cleaned properly.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Particle size

The apparent maximum linear dimension of a particle in the plane of observation as seen with a microscope, or the equivalent diameter of a particle detected by automatic instrumentation. The equivalent diameter is the diameter of a reference sphere having known properties and producing the same responses in the sensing instrument as the particle being measured. (Federal Standard 209D, Stuttgart 1991)

Diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the response produced by the particle being measured

NOTE For discrete-particle-counting, light-scattering instruments, the equivalent optical diameter is used (ISO 14644-1:1999 (E))

The maximum linear dimension of a reference which is usually described by the equivalent diameter.

The equivalent diameter is the diameter of a reference sphere having known properties and producing the same response in the Instrument used as the particle being measured.

NOTE: Different measurement methods produce different equivalent diameters.

(VDI 2083: Blatt 4: 1996 Düsseldorf)

Diameter of any particle, determined by comparison with defined reference particles (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

The apparent maximum linear dimension of a particle in the plane of observation as seen with a microscope or the equivalent diameter of a particle detected by automatic instrumentation. (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Particle size distribution

Cumulative distribution of particle concentration as a function of particle size (ISO 14644-1:1999 (E))

Distribution of cumulative frequency of particle concentration as a function of particle diameter (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

Particulate contamination

Particles having the potential to affect the process, the product, the personnel or the facilities.

Note 1: The principal way for particles to settle on surfaces is by deposition. Deposition processes are primarily driven by physical effects such as gravitation, electrostatic attraction, diffusion, thermophoresis or a combination of these.

Note 2: Particulate contaminations may be generated by reactive, chemical processes such as corrosion or abrasion of a surface.

(VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Particulate percent area coverage

The fraction of the surface that is covered by particles, reported as total particle projected area divided by total surface area. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Pasteurization

The process of heating milk or other liquids to a moderate temperature for a specified period of time. This exposure kills most species of pathogenic bacteria and significantly retards the development of others (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Percentage of the theoretical (stoichiometric)

quantity (theoretical percentage)

Percentage of the theoretically required quantity of chemicals (100% is the stoichiometrically required quality) used for the regeneration of ion exchangers. As a rule, leaner-than-stoichiometric quantities are used (in excess of 100%)

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Performance qualification (PQ, also: clearance for production)

A series of tests and measurements shall be carried out in order to demonstrate compliance of the cleanroom installation with the specified design parameters, taking into account the personnel and the specified processes or activities in the occupancy state “in operation” (see also VDI 2083 Part 5.1). (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Physical contamination

Interference with the process, the product, the personnel or the facilities caused by physical factors such as humidity, temperature, vibration, electrostatic and electromagnetic fields. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Physisorption

The removal of specific substances (here AMC) by way of physical adhesion to the active surface of the sorbent and bonding by weak interaction, cf. ->chemisorption.

Note: Unlike chemisorption, physisorption is reversible.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Planning qualification

An integral planning test for complying with the requirements laid down in the technical specifications (planning objectives), performed by an authority independent of the project organization. (VDI 2083: Blatt 12: 2000-01 Düsseldorf)

Point of contact

A designated individual position in an organization, the occupant of which has the responsibility for assuring that contractual contamination control requirements are met. This position is identified and serves as a focal point for all activities concerning contamination control. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Point of use (POU)

The point where a particular activity is carried out. Typically the final filter of a ventilation system is point of use, i.e. the filter is an integrated part of the roof. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Actual consumer (introduction into the process), e.g. water quench in a wet etch bench. (as defined in VDI 2083 Part 10) (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

zone within which specified parameters shall be complied with (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

pre-acceptance test (initial acceptance)

qualitative and quantitative verification of the specified parameters and/or acceptance criteria of an ME at the contractor’s site after manufacture (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Pre-filter

A filter unit positioned in front of any other filter, used to reduce blockage of the main filter caused by containments. The pre-filter has in general a lower removal rating than the main filter. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Air filter fitted upstream of another filter to reduce the challenge on that filter (ISO 14644-4:2001 (E))

Present Engineering Classes

These Classes are used mainly in rooms where electronic and engineering items are manufactured. Most of these standards are based on one of the various of the US Federal Standard 209.

Some countries completely adopted FS 209, while others made their own national version, similar to FS 209. Some made minor changes of the classes to comply with the metric system, but all changed the denomination of the classes.

Major national standards

Country	Standard	Year	Description
Australia	AS 1386	1989	Cleanroom and clean work stations
France	AFNOR X44101	1981	Definition of cleanroom levels
Germany	VDI 2083.3	1993	Contamination control measuring technique for clean air rooms
Holland	VCCN 1	1992	Dust and microorganism classification of air
Japan	JIS-B-9920	1989	Measuring methods for airborne particles in cleanroom and evaluating methods, etc.
Russia	Gost-R 50766	1995	Cleanroom classification, general requirements
UK	BS 5295	1989	Environmental cleanliness in enclosed spaces
US	FS 209E	1992	Airborne particulate cleanliness and clean zones

A comparison of major engineering cleanroom classes in the world

USA 209E 1992		ISO 14644-1 1997	Japan B 9920 1989	France X44101 1981	Germany VDI 2083 1990	UK BS 5295 1989	Australia AS 1386 1989
		ISO Class 1	1

		ISO Class 2	2		0
	M1
1		ISO Class 3	3		1	C	0,035
	M2
10		ISO Class 4	4		2	D	0,35
	M3
100		ISO Class 5	5	4,000	3	E, F	3,5
	M4
1,000		ISO Class 6	6	–	4	G, H	35
	M5
10,000		ISO Class 7	7	40,0000	5	J	350
	M6
100,000		ISO Class 8	8	4,000,000	6	K	3500
	M7
		ISO Class 9			7	L

Note: The M values for FS 209E (and the ISO values) are in metric units. The M figures are therefore elevated above the line of the others, which are given in cubic feet. FS 209E class 100 therefore corresponds to M class 3.5 and ISO 5.

(Cleanroom Technology / Fundament of Cleanroom Technology, FESTO AG & Co., Ruiter Strasse 82, 73734 Esslingen; Festo Singapore: Jiang Hong, Christian Burdin, Edward Gasper, Festo Germany: Robert Strommer)

Prevention of pollution

use of processes, practices, techniques, materials, products, services or energy to avoid, reduce or control (separately or in combination) the creation, emission or discharge of any type of pollutant or waste, in order to reduce adverse environmental impacts (International Standard, ISO/FDIS 14001, 2004)

Protection factor

The protection factor is the ratio of emission to exposure for the respective type of protection (see also Figure 3).

The protection factor shall be related to the type of protection:

-person-related,

-product-related,

- environment-related or

-combinations of the above

(VDI 2083: Blatt 16.1: 2010-08 Düsseldorf)

Protozoa

A major group of microorganisms comprising the simplest forms of life in the animal kingdom (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Pyrogen

In the medical domain, pyrogens are substance that can induce fever when administered parenterally. This includes (bacterial endotoxin) as well as particles (Section 3.6, e.g. rubber abraded from injection bottles, microscopic plastic particles). (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

A substance that causes fever (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Qualification

Working process in accordance with defined procedures, serving to determine and/or verify the performance of a cleanroom installation or a part thereof. (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Documented process of demonstration that

a production unit,
an installation or a unit,
an activity,
a process,
a product,
an organisation, or
a combination of the aforementioned

is capable of meeting the specified requirements.

Note: In addition to the term “qualification”, the them “validation” is used in the field of pharmaceutics; in this field, the term “validation” subsumes, among other things, all activities verifying the suitability of processes.

(VDI 2083: Blatt 5.1: 2007-09 Düsseldorf)

Prospective definition and checking of systems, subassemblies, components and materials with the objective of proper functioning and achieving the expected results. (VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Quality

Degree to which a set of inherent characteristics fulfils requirements. (ISO 9000: 2000)

Note 1: The term “quality” can be used with adjectives such as poor, good or excellent.

Note 2: “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Quality inspection

Establishing to what degree an item fulfils a specified quality requirement. (DIN 55350-17)

Note 1: Quality inspections are performed on the basis of inspection characteristics. It must be specified which characteristics the quality inspection refers to and which stage of implementation of the quality requirement is relevant.

Note 2: Quality inspections may be performed at any time and any site, e.g. referred to each stage of the quality cycle. The term “inspection”, “countercheck”, “preliminary check”, “check”, “compliance test” and “confirmation test” are often used as synonyms for “quality inspection”, althougt in a limited sense. These terms should, therefore, be avoided, or the definition applying to the respective application should be specified.

Note 3: Above definition and notes are based on DIN 55350-17

Note 4: The quality inspection may refer to one of the items below:

-material product,

-immaterial product,

-combination of material and immaterial products,

-activity or process

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Regulated operation

(operation in a regulated environment)

Operation of a system subject to legal stipulations.

Note: As an example, consider the operation of a GMP-regulated pharmaceutical plant.

(VDI 2083: Blatt 3.1: 2012-06 Düsseldorf)

Rejection rate (R)

Mean percentage of the undissolved particles and of the ionic and molecular (organic) substances removed by the membrane.

R = (1 – C_P/C_f) x 100

where

C_f feed solution concentration of the substance considered

C_P filtrate or permeate solution concentration of the substance considered

The rejection rate depends on the operating conditions as well as on the type of the membrane used. (based on EN 14652)

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Requalification

Execution of the test sequence specified for the installation to demonstrate compliance with ISO 14644-1 according to the classification of the installation, including the verification of the selected pre-test conditions (ISO 14644-2_2000 (E))

Performance of qualification activities activities at specified intervals and after substantial changes to the processes or subsystems. (VDI 2083: Blatt 5.1: 2007-09 Düsseldorf)

Reuse

Process of returning water from production for reuse and for the production of ultrapure water; with or without treatment, depending on the level of contamination.

Note: Reuse = recycling + reclaim

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Resistance to earth

Electrical resistance between an electrode on the surface (3.5) of the material and the grounding point of the material (3.1), when the latter is at a potential of 0 V (“ground”). (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Resistivity

Capability of dissipating any existing charge in a controlled manner and sufficiently raoidly.

Note: The conductivity of a material depends on its resistivity: the higher the resistivity, the lower the conductive or static dissipative and insulating materials (3.4).

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Salt passage

Percentage of salts passing through a separating membrane, expressed in terms of the ratio of concentration of salt on the permeate side of the membrane relative to the concentration of salt in the feedwater. (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Saturation index (SI)

Logarithm of the ratio of the product of the ion activities of calcium and carbonate over the solubility product of calcite under the prevailing thermodynamic conditions. (as defined in DIN 51009; based on DIN 38404-10)

Note: The auxiliary quantity SI can be used to describe the calcite saturation of water.

SI < 0: Calcite will dissolve in the water

SI = 0: The water is at calcite equilibrium

SI > 0: Calcite will precipitate from the water

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Separation descriptor [A_a:B_b]

"numerical abbreviation summarizing the difference in cleanliness classification between two areas as ensured by a separative device under specified test conditions, where

A is the ISO class inside the device;

a is the particle size at which A ist measured

B is the ISO class outside the device;

b is the particle size at which B is measured."

(EN ISO 14644-6:2007)

Separation device

"equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume.

NOTE: Some industry-specific examples of
separative devices are clean air hoods, containment enclosures, gloveboxes, isolators and minienvironments."

(EN ISO 14644-6:2007)

Separation efficiency

separation efficiency= ((c _roh -c _rein)/c _roh)x 100

where

c _roh crude-air concentration of a specific substance (->AMC)

c _rein clean-air concentration of a specific substance (AMC)

Note 1: The separation efficiency depends on the filter load; it is thus a function of time.

Note 2: The term “efficiency“ is a term adopted from particle filtration; it is not used in this guideline.

Note 3: The separation efficiency is expressed as a percentage.

(VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Settle plate

Appropriate vessel (such as a petri dish) of adequate size with a suitable, sterile nutrient medium, left uncovered for a specified time to collect viable particles from the air.

[DIN EN ISO 14698-1]

(VDI 2083: Blatt 18: 2012-01 Düsseldorf)

"suitable container (e.g. a Petri dish) of appropriate size, containing an appropriate, sterile, culture medium, which is left open for a defined period to collect viable particles depositing from the air"

(EN ISO 14644-6:2007)

Significant surface

Any surface of an item or product which is required to meet established cleanliness level requirements. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Silt density index (SDI, Plugging factor PF)

Ratio of the times required to filter a given volume of water (500ml) through a 0,45µm pore size membrane under a constant pressure (2 bar p_e) in percent per minute, measured before and after a constant filter test time of T=15min as a function of this test time. (as defined in ASTM D 4189)

Note: The SDI is a measure of the contamination of water with colloid-disperse substances.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Slit sampler

An impaction sampler for microbial analysis in which airborne particles are collected onto a slowly rotating agar plate making it possible to obtain the microbiological profile of a facility as a function of time. The impact forces in such an apparatus are obtained by allowing the air to be analysed to pass through a very fine slit. (Introduction to Contamination Control and Cleanroom Technology, 1999)

SMIF-Pod (standard mechanical interface pod)

ME with a standardised interface pod)

ME with a standardised mechanical interface (opening and connecting mechanism) for automated opening without human intervention. (VDI 2083: Blatt 16.2: 2021-04 Düsseldorf)

Specification

Document stating requirements. [ISO 9000: 2000]

Note: A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Spore

A subcellular body produced by some species of bacteria which is considerably more resistant to harsh conditions such as heat, disinfectants and radiation, than the vegetative form (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Softening

Reduction of water hardness by exchanging the alkaline-earth ions (primarily calcium and magnesium) with sodium ions. This is accomplished by directing the flow of water over a bed of cation-exchange-resin beads in which the cations are available in the form of sodium (as defined in EN 14743) (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Sorption

Generic term for the enrichment of a substance in the boundary region between different phases (e.g. -> absorption, -> adsorption, ->desorption). Sorption will occur predominantly at liquid-solid and gassolid interfaces. (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Enrichment of a substance in the boundary region between different phases (e.g. absorption, adsorption, desorption).

Note: sorption will occur predominantly at liquid-solid and gas-solid interfaces.

(VDI 2083: Blatt 8.1: 2014-10 Düsseldorf)

Standard leak penetration

"leak penetration detected by a discrete-particle counter or aerosol photometer with a standard sample flowrate when the sampling probe is stationary in front of the leak

NOTE: Penetration is the ratio of the particle
concentration downstream of the filter to the concentration upstream."

(EN ISO 14644-6:2007)

Start-up

Act of preparing and bringing an installation into active service, including all systems

EXAMPLE Systems may include procedures, training requirements, infrastructure, support services, statutory undertakings requirements.

(ISO 14644-4:2001 (E))

Preparation and commissioning of a cleanroom installation including all systems, following the execution of a construction activity. All procedures and requirements relevant to the functioning of a system, such as documentation, training and the operation of auxiliary equipment, are covered. (VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Static dissipative

Property of a material allowing an electrostatic charge to dissipate across its surface and/or through its volume within a period of time that is short compared to the time within which said charge is generated or the time within which said charge can cause an electrostatic problem

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

Static dissipative material

Material allowing an electrostatic charge to dissipate on its surface (3.5) and/or through its volume, within a period of time that is short compared to the time within which said charge is generated or can cause an electrostatic problem.

Note: Floorings, for instance, are classified as static dissipative according to DIN EN 14041 if their volume resistance measured to DIN EN 1081 is 10⁹ Ω or less.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Stationary phase

The stage in the growth pattern of microorganisms where the number of new cells formed is equal to the number of cells that die (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Sterile

Cleanliness defintion (Introduction to Contamination Control and Cleanroom Technology, 1999)

Cleanliness definition. Different definition can be recognised: Free from living organisms or free from living microorganisms (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Sterilization

Any process or activity leading to the complete elimination of microbial activity. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Process which eliminates all forms of viable microorganisms from a product. (based on ISO 14160) (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Total elimination of biological entities capable of reproduction. (VDI 2083: Blatt 16.1: 2010-08 Düsseldorf)

Process of inactivation of all microorganisms and all relevant microbial spores. [DIN EN ISO 14159] (VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Surface

This Guideline applies to all surfaces which

face the clean area and / or

are in contact with the cleanroom product

Textiles and other porous materials have no defined closed surface. Particles and other contamination are also emitted from within the material.

(VDI 2083: Blatt 4: 1996 Düsseldorf)

For the purposes of this guideline, the term “surface” denotes any surface

-facing the controlled environment,

-being located within the controlled environment and/or

-coming into contact with the product.

(VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Any area

-facing the controlled environment,

-being located within the controlled environment, and/or

-coming into contact with the product

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

All surfaces which

-are related within the controlled area and/or

-come into contact with the product manufactured.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Surface characteristics

Characteristics which are of importance in view of the surface cleanliness (such as roughness, surface conductivity, cleanability, accessibility, waviness) (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Characteristics relevant to surface cleanliness (such as roughness, conductivity, cleanability, accessibility, waviness). (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Surface chemical contamination

Substance on the surface which, owing to its physical and/or the product, the process, the installation and/or the personnel. (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Molecular (chemical, non-particulate) deposits on the surface (3.5) of a material (3.1), which may have a deleterious effect on humans, the product, process, environment or equipment. [VDI 2083 Blatt 8.1, DIN EN ISO 14644-6]

Note: Surface chemical contamination can be caused by, e.g. AMC and can cause AMC.

(VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Surface cleanliness

Surface cleanliness as defined by this Guideline is the absence of such particulate and non-particulate contamination which affect the process or the product. It is possible that particulate contamination is converted to non-particulate contamination, and vice versa. The definition of a clean surface as given by this Guideline includes its suitability for the intended use, which is determined by specified physical, chemical and constructional properties. (VDI 2083: Blatt 4: 1996 Düsseldorf)

For the purposes of this guideline, surface cleanliness denotes the absence of particulate contaminations which might affect the process, the product, the personnel or the facilities. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Absence of particulate contaminations (VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Surface cleanliness class (particulate) (SCC)

Number of individual particles on a reference surface area of I cm², referred to a reference particle size of 1µm, in a decimal evaluation system. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Surface electric potential

Isolated patches of positive or negative charge on the surface of the workplace or the product give rise to a difference in potential between these charges. The surface electric potential is a voltage which can be indicated by suitable measuring instruments (such as teraohm meters or field-strength meters). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Surface molecular contamination (SMC)

Presence on the surface of a product or analytical instrument of molecular (chemical, non-particulate) species in the sorbed state which may have a deleterious effect on the product, process or equipment in the cleanroom or controlled environment (ISO 14644-8: 2003-09)

Surface particle cleanliness by particle concentration class (SPC; SP class)

Classification in terms of the number of individual particles on a reference surface area, referenced on a reference particle diameter

Note: The reference surface area is 1 cm² as per VDI 2083 Part 9.1 or 1 m² as per DIN EN ISO 14 644-9. The regulation used as a basis in the particular case shall be stated.

(VDI 2083: Blatt 9.2: 2017-01 Düsseldorf)

System space of a piece of equipment

The system space of a piece of equipment comprises the entire three-dimensional geometrical space of a piece of equipment. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Entire three-dimensional geometrical space of a piece of equipment (VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Technical specifications (performance specification)

Compilation of all customer requirements (delineation) and the contractor’s services (performance specification) with regard to the scope of supply and performance. (based on VDI/VDE 3694) (VDI 2083: Blatt 12: 2000-01 Düsseldorf)

Tenside

Surfactant. An agent, both hydrophobic as well as hydrophilic in nature. Used for cleaning purposes as it can be used to dissolve fats and make them water-soluble. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Terminal filter

Filter installed immediately upstream of the duct end (where the air is discharged into the cleanroom).

Note: ISO 16444 uses the term “terminal filter” for all suitable filters. As examples, this standard lists HEPA (High Efficiency Particulate Air) and ULPA (Ultra Low Penetration Air) filters where these are installed in a terminal position upstream of where the air is discharged into the cleanroom.

(VDI 2083: Blatt 4.1: 2006-10 Düsseldorf)

Test method

The overall process from sampling up to the interpretation and documentation. (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Overall process starting with sampling and ending with the interpretation of the results and documentation. (VDI 2083: Blatt 18: 2012-01 Düsseldorf)

Time-of-flight particle size measurement

"measurement of aerodynamic particle diameter determined by the time required for travelling the distance of two fixed planes.

NOTE: This measurement utilizes the particle velocity shift caused when a particle is introduced into the flow field with different velocity."

(EN ISO 14644-6:2007)

Total cell count

Number of all microbial cells (bacteria, algae, moulds, etc.) referred to a specified volume, mass or surface of a sample.

Note: Bacteria counts are mostly achieved by applying a DNA-specific marker dye, e.g. acridine-orange or DAPI, and subsequent counting by means of microscopic processes. The total cell count determines all cells without allowing statements as to their activity or vitality.

(VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

Total Mass Loss (TML)

The mass that outgases from a material, as specified in ASTM E595, expressed as a percentage of the initial mass of the specimen. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Toxin

A poison. The term is frequently used to refer specifically to a protein product (or other biomolecule) produced by some higher plants, certain animals and pathogenic bacteria, which is highly toxic to other living organisms (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Touch plates

Agar plates used for detecting the presence of microbial contaminants on hands. These sterile dishes are often used by operators engaged in aseptic filling (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

t90-time

The time elapsing between the beginning of the measurement and that point in time when the indication is 90% of the final value (final concentration). (VDI 2083: Blatt 9.2: 2009-07 Düsseldorf)

Time elapsing between the beginning of the measurement and that point in time when the indication is 90% of the final value (final concentration).

Note: In case of first-time measurements and/or changes to the installation, the t₉₀ time specific for the substance in question must be determined and specified. It is recommended to verify and document the t₉₀ time at regular intervals.

(VDI 2083: Blatt 8.1: 2014-10 Düsseldorf)

Turbidity

Reduction in transparency of a liquid, due to the presence of non-dissolved substances. It is expressed in FTU (or NTU in the USA). (as defined in ISO 7027) (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

The cloudiness of a liquid caused by the presence of finely divided suspended material. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Turbulent induction flow

Air distribution where the supply air entering the controlled environment blends with the air in the room through induction (ISO 14644-l). (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Air distribution where the supply air entering the cleanroom or clean zone mixes with internal air by means of induction

[DIN EN ISO 14644-1, 3.2.8, non-unidirectional airflow]

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

U descriptor

The maximum allowable concentration (particles per cubic meter of air) of ultrafine particles. The U descriptor serves as an upper confidence limit or as the upper limit for the location averages, or both, as appropriate, U descriptors are independent of airborne particulates cleanliness classes, and may be specified alone or in conjunction with one or more airborne particulate cleanliness classes. (Federal Standard 209D, Stuttgart 1991)

"measured or specified concentration, in particles per cubic metre of air, including the ultrafine particles

NOTE: The U descriptor may be regarded as an upper limit for the averages at sampling locations (or as an upper confidence limit, depending upon the number of sampling locations used to characterize the cleanroom or clean zone ). U descriptors cannot be used to define airborne particulate cleanliness classes, but they may be quoted independently or in conjunction with airborne particulate cleanliness classes."

(EN ISO 14644-6:2007)

UDF

Unidirectional Flow. New term replacing LAF. UDF is an airflow which has a single flow direction and may or may not contain uniform velocities of airflow. UDF results in quick, directed transport of particles out of the clean zone. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Ultrafine particles

Particles in the size range from approximately 0.02 µm to the upper limit of detecability of the DPC described in Appendix D. Ultrafine particles are operationally defined by the relationship for counting efficiency vs. particle size of Appendix D. (Federal Standard 209D, Stuttgart 1991)

Particles in the size range from approximately 0.01 µm to the upper detection limit of the DPC. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Particle with an equivalent diameter less than 0,1 µm (ISO 14644-1:1999 (E))

Particle whose equivalent diameter is less than o,1µm (VDI 2083: Blatt 1: 2003-06 Düsseldorf)

Unidirectional airflow

Airflow having generally parallel streamlines, operating in a single direction, and with uniform velocity over its cross section; previously referred to as “laminar” airflow. (Federal Standard 209D, Stuttgart 1991)

Controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately parallel streamlines

NOTE This type of airflow results in a directed transport of particles from the clean zone

(ISO 14644-4:2001 (E))

Unilateral flow

Controlled airflow with uniform velocity and almost parallel streamlines over the entire cross section of the controlled environment (ISO 14644-l).

Note: Such a flow affords a directed transport or particles, usually out of the controlled environment.

(VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Controlled airflow through the entire cross-section of a cleanroom or a clean zone with a steady velocity and airstreams that are considered to be parallel

[DIN EN ISO 14644-1, 3.2.7, unidirectional airflow]

Note: Such a flow affords a directed transport of particles, usually out of the controlled environment.

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Upper confidence limit (UCL)

An upper limit of the estimated mean which has been calculated so that, in a specified percentage of cases, its value exceeds the true population mean, both means having been sampled from a normal (Gaussian) distribution. In this Stndard, a 95 % UCL is used. (Federal Standard 209D, Stuttgart 1991)

Usability/ suitability for use

Quality and resistance/durability to the gradual failing, as a consequence of ageing, of characteristics of the surface of a piece of equipment, which are required for usability, or of its wear resistance. (VDI 2083: Blatt 9.1: 2006-12 Düsseldorf)

Note: Resistance to ageing is a characteristic inherent to the physico-chemical structure. Resistance to wear is based on the mechanical characteristics of the piece of equipment and can be tested using physical methods.

(VDI 2083: Blatt 9.1: 2021-01 Düsseldorf)

Validation

Full and detailed documentation that all processes and procedures are functioning in the manner for which they were designed. (Introduction to Contamination Control and Cleanroom Technology, 1999)

Documented confirmation that the requirements of a specified application are met.(VDI 2083 Part 5.1) (VDI 2083: Blatt 3.1: 2012-06 Düsseldorf)

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (ISO 900:2000)

Note 1: The term “validated” is used to designate the corresponding status.

Note 2: The use conditions for validation can be real or simulated.

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Verification

The procedure for determining the compliance of air in a cleanroom or clean zone to an airborne particulate cleanliness class limit or a U descriptor, or both, as specified. (Federal Standard 209D, Stuttgart 1991)

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. (ISO 9000: 2000)

Note 1: The term “verified” is used to designate the corresponding status.

Note 2: Confirmation can comprise activities such as:

-performing alternative calculations

-comparing a new design specification with a similar proven design specification

-undertaking tests and demonstrations

-reviewing documents prior to issue

(VDI 2083: Blatt 11: 2008-01 Düsseldorf)

Viable

Capable of growing and living. The ability of microorganisms to grow and form visible colonies on an appropriate medium (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

Viable Unit VU

"one or more viable particles that are enumerated as a single unit

NOTE: When viable units are enumerated as colonies on agar media, it is common usage to name them colony forming units (CFU). One CFU might consist of one or more VU."

(EN ISO 14644-6:2007)

Virtual impactor

"instrument to separate the particle used sizing by inertial force to collide on the hypothetical (virtual) surface.

NOTE: Large particles pass through the surface into a stagnant volume and small particles deflected with the bulk of the original airflow."

(EN ISO 14644-6:2007)

Virus

A group of minute infectious agents that, with certain exceptions, cannot be visualized with a light microscope. Viruses are characterized by their lack of independent metabolism and canreplicate only within a living host cell (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

VOC (volatile organic compounds)

Volatile organic compounds in the retention range between n-hexane C₆ and n-hexadecane C₁₆ and generic term used to subsume VVOC (3.3), VOC, SVOC (3.3) and TVOC (3.3). (VDI 2083: Blatt 17: 2013-06 Düsseldorf)

Volatile condensable material (VCM)

Gaseous products released from a material under specified conditions of temperature and pressure, that condense at other specified conditions of temperature or pressure or both. (Military Standard Product Cleanliness Levels and Contamination Control Program MIL-STD-1246C, 11. April 1994)

Water hardness units and methods of conversion

According to the SI system of units, the content of alkaline-earth ions, i.e. the total hardness is expressed in moles per litre or, considering the low concentration, in millimoles per litre (mmol/l) (see conversion table) (VDI 2083: Blatt 13.1: 2009-01 Düsseldorf)

z-value

The increase in temperature that will improve the destruction rate of microorganisms by a factor of 10. The z-value is used in relation to sterilization in an autoclave (Introduction to Contamination Control and Cleanroom Technology; Dr. Matts Ramstorp, Malmö, 2000; WILEY-VCH Verlag GmbH in Weinheim)

The Cleanroom Wiki: Terms and definitions

Absorption

acceptance test (acceptance, qualification)

ACC filter

Acess device

Acid

Acid capacity (KS)

Action level

Active minienvironment

Active surface

Activity

Adapted minienvironment

Adapted SMIF

Adsorption

Aerobe

Aerosol challenge

Aerosol generator

Aerosol photometer

Aerosole

Agar

Airborne contamination

Air Exchange Rate

Airborne molecular contamination (AMC)

Airborne particle

Air changes

Air changes

Airlock

Air / gas supply

Air velocity

Alcohol

Alert level

Alga

Algae

Alkali

Alkalinity

Alternative test method

AMC (airborne molecular contamination)

AMC filter

Anaerobic

Anaerobic microorganisms

Anderson sampler

Anisokinetic sampling

Antiseptic

Antisepsis

Antistatic

Antistatic material

Antistatic properties

As-built cleanroom (facility)

Aseptic

Aseptic filling

Aseptic technique

Associated controlled environment

ASTM

ATR

At-rest cleanroom (facility)

Attenuated total reflection

AU

Audit

Auditor

Audit trail

Autoclave

Average air flow rate

Background

Background noise

Bacteria

Bacterial

Bacteriostat

Bacteriostatic

Barrier

Barrier class

Base

Base capacity (KB)

Base noise

Bioaerosol

Biocide

Biocleanroom

Biocontamination (biological contamination)

Biofilm (bacterial lawn)

Biofouling (biological fouling)

Biological agents