EN ISO 14644-18:2023
(Main)Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)
This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles, microorganisms or pyrogens) is considered as a special property of consumables. Identification of associated risks are considered.
This document complements cleanroom operation as outlined in ISO 14644-5.
This document gives guidance concerning:
— determination of cleanroom suitability of consumables in general;
— specification of requirements for an intended use of a consumable by the customer with respect to functional performance, cleanliness attributes and special properties;
— specification of properties for a designed use of a consumable by supplier;
— assessment of a consumable for an appropriate use;
— documentation.
Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom.
Cleaning agents, disinfectants and lubricants are considered as consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all consumables.
This document does not apply to:
— design details of consumables;
— testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip resistance of flooring;
— health and safety requirements; legal requirements can apply in specific countries;
— cleanability;
— (raw) materials which are added within the production process as ingredients;
— performance or function testing;
— transport containers;
— process media such as gases or liquids;
— the functional performance of cleaning agents, disinfectants and lubricants.
Reinräume und zugehörige Reinraumbereiche - Teil 18: Bewertung der Reinraumtauglichkeit von Verbrauchsgegenständen (ISO 14644-18:2023)
Dieses Dokument bietet eine Anleitung für die Bewertung persönlicher und nicht persönlicher Verbrauchsgegenstände für ihre geeignete Verwendung in Reinräumen, reinen Bereichen oder kontrollierten Bereichen auf der Grundlage der Produkt- und Prozessanforderungen, der Reinheitsattribute und der funktionalen Leistungseigenschaften. Die behandelten Reinheitsattribute sind Partikel oder Chemikalien in der Luft oder auf Oberflächen. Biokontamination (lebensfähige Partikel/Mikroorganismen oder Pyrogene) gilt als besondere Eigenschaft von Verbrauchsgegenständen. Die Identifizierung der damit verbundenen Risiken wird berücksichtigt.
Dieses Dokument ergänzt den in ISO 14644 5 beschriebenen Reinraumbetrieb.
Dieses Dokument bietet eine Anleitung für:
die Bestimmung der Reinraumtauglichkeit von Verbrauchsgegenständen im Allgemeinen;
die Spezifikation von Anforderungen an die bestimmungsgemäße Verwendung eines Verbrauchsgegenstandes durch den Kunden im Hinblick auf die funktionalen Leistungseigenschaften, Reinheitsattribute und besondere Eigenschaften;
die Spezifikation von Eigenschaften für eine vorgesehene Verwendung eines Verbrauchsgegenstandes durch den Lieferanten;
die Bewertung eines Verbrauchsgegenstandes für eine geeignete Verwendung;
die Dokumentation.
Informative Anhänge werden verwendet, um Beispiele für persönliche und nicht persönliche Verbrauchsgegenstände, Überprüfungsverfahren für Reinheitsattribute und die potenzielle Auswirkung von Verbrauchsgegenständen auf einen Reinraum aufzuführen.
Reinigungsmittel, Desinfektionsmittel und Schmierstoffe werden im Hinblick auf ihre Verpackung als Verbrauchsgegenstände betrachtet, da an ihre Verpackung wahrscheinlich die gleichen Reinheitsanforderungen bestehen, wie für alle Verbrauchsgegenstände.
Dieses Dokument ist nicht anwendbar für:
Gestaltungsdetails von Verbrauchsgegenständen;
die Prüfung der funktionalen Leistungseigenschaften von Materialien, z. B. Barriereeigenschaften von Handschuhen, Verschleiß- und Rutschfestigkeit von Bodenbelag;
Gesundheits- und Sicherheitsanforderungen; in bestimmten Ländern können gesetzliche Anforderungen gelten;
Reinigungsfähigkeit;
(Roh-) Materialien, die innerhalb des Produktionsprozesses als Inhaltsstoffe hinzugefügt werden;
Leistungs- oder Funktionsprüfungen;
Transportbehälter;
Prozessmittel wie Gase oder Flüssigkeiten;
die funktionalen Leistungseigenschaften von Reinigungsmitteln, Desinfektionsmitteln und Schmierstoffen.
Salles propres et environnements maîtrisés apparentés - Partie 18: Évaluation de l’aptitude à l’emploi des consommables (ISO 14644-18:2023)
Le présent document fournit des recommandations concernant l’évaluation des consommables pour le personnel et autres consommables pour leur usage approprié dans les salles propres, zones propres ou zones maîtrisées, sur la base des exigences des produits et procédés, des attributs de propreté et des propriétés de performances fonctionnelles. Les attributs de propreté couverts sont les particules ou les produits chimiques dans l’air ou sur les surfaces. La biocontamination (particules viables, microorganismes ou pyrogènes) est considérée comme une propriété particulière des consommables. L’identification des risques associés est considérée.
Le présent document complète l’exploitation des salles propres telle qu’elle est décrite dans l’ISO 14644-5.
Le présent document fournit des recommandations concernant:
— la détermination de l’aptitude à l’emploi en salle propre des consommables en général;
— la spécification des exigences pour un usage prévu d’un consommable par le client en matière de performances fonctionnelles, d’attributs de propreté et de propriétés particulières;
— la spécification des propriétés pour un usage de destination d’un consommable par le fournisseur;
— l’évaluation d’un consommable pour un usage approprié;
— la documentation.
Des annexes informatives sont utilisées pour énumérer des exemples de consommables pour le personnel et autres consommables, des méthodes de vérification pour les essais d’attributs de propreté et l’impact potentiel des consommables sur une salle propre.
Les agents nettoyants, désinfectants et lubrifiants sont considérés comme des consommables en ce qui concerne leur emballage, car il est probable que leur emballage possède des exigences de propriété communes avec tous les consommables.
Le présent document ne s’applique pas à ce qui suit:
— détails de la conception des consommables;
— essai de performances fonctionnelles des matériaux, par exemple propriétés barrières des gants, résistance à l’usure et au glissement du revêtement de sol;
— exigences en matière de santé et de sécurité; des exigences légales peuvent s’appliquer dans certains pays;
— nettoyabilité;
— matières (premières) ajoutées en tant qu’ingrédients dans le procédé de production;
— essais de performances ou fonctionnels;
— conteneurs de transport;
— utilités process comme les gaz ou les liquides;
— performances fonctionnelles des agents nettoyants, désinfectants et lubrifiants.
Čiste sobe in podobna nadzorovana okolja - 18. del: Ocena ustreznosti potrošnih materialov (ISO 14644-18:2023)
Ta dokument podaja smernice za ocenjevanje osebnega in neosebnega potrošnega materiala glede njegove ustrezne uporabe v čistih sobah, čistih območjih ali nadzorovanih območjih na podlagi zahtev za izdelek in proces, atributov čistosti in funkcionalnih lastnosti delovanja. Obravnavani atributi čistosti
so delci ali kemikalije v zraku ali na površinah. Biokontaminacija (živi delci, mikroorganizmi ali pirogeni) velja za posebno lastnost potrošnih materialov. Upoštevana je identifikacija povezanih tveganj.
Ta dokument dopolnjuje delovanje čiste sobe, kot je določeno v standardu ISO 14644-5.
Dokument podaja smernice za:
– določanje ustreznosti čiste sobe za potrošne materiale na splošno;
– specifikacijo zahtev za predvideno uporabo potrošnega materiala s strani stranke v smislu
funkcionalnega delovanja, atributov čistosti in posebnih lastnosti;
– specifikacijo lastnosti za predvideno uporabo potrošnega materiala s strani dobavitelja;
– oceno potrošnega materiala za ustrezno uporabo;
– dokumentacijo.
Informativne priloge se uporabljajo za navedbo primerov osebnih in neosebnih potrošnih materialov, metod preverjanja za preskušanje atributov čistosti in potencialnih vplivov potrošnih materialov na čisto sobo. Čistilna sredstva, razkužila in maziva se štejejo za potrošni material glede na njihovo embalažo, saj mora embalaža najverjetneje izpolnjevati podobne zahteve glede čistoče kot vsi potrošni materiali.
Ta dokument se ne uporablja za:
– zasnovne podrobnosti potrošnega materiala;
– preskušanje funkcionalnih lastnosti materialov, npr. pregradne lastnosti rokavic, obraba in odpornost talnih oblog
proti zdrsu;
– zdravstvene in varnostne zahteve; v določenih državah lahko veljajo pravne zahteve;
– možnost čiščenja;
– (surovine) materiale, ki so dodani v proizvodnem procesu kot sestavine;
– preskušanje uspešnosti ali delovanja;
– transportne zabojnike;
– procesne medije, kot so plini ali tekočine;
– funkcionalno delovanje čistilnih sredstev, razkužil in maziv.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Čiste sobe in podobna nadzorovana okolja - 18. del: Ocena ustreznosti potrošnih
materialov (ISO 14644-18:2023)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability
of consumables (ISO 14644-18:2023)
Reinräume und zugehörige Reinraumbereiche - Teil 18: Bewertung der
Reinraumtauglichkeit von Verbrauchsgegenständen (ISO 14644-18:2023)
Salles propres et environnements maîtrisés apparentés - Partie 18: Évaluation de
l’aptitude à l’emploi des consommables (ISO 14644-18:2023)
Ta slovenski standard je istoveten z: EN ISO 14644-18:2023
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 14644-18
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2023
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
18: Assessment of suitability of consumables (ISO 14644-
18:2023)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 18: Évaluation de l'aptitude à l'emploi des 18: Bewertung der Reinraumtauglichkeit von
consommables (ISO 14644-18:2023) Verbrauchsgegenständen (ISO 14644-18:2023)
This European Standard was approved by CEN on 17 September 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-18:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-18:2023) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2024, and conflicting national standards shall be
withdrawn at the latest by April 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14644-18:2023 has been approved by CEN as EN ISO 14644-18:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-18
First edition
2023-10
Cleanrooms and associated controlled
environments —
Part 18:
Assessment of suitability of
consumables
Salles propres et environnements maîtrisés apparentés —
Partie 18: Évaluation de l’aptitude à l’emploi des consommables
Reference number
ISO 14644-18:2023(E)
ISO 14644-18:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 14644-18:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Description and cleanroom suitability properties of consumables .5
4.1 Types of consumables. 5
4.2 Properties of consumables . 5
4.2.1 General . 5
4.2.2 Functional performance properties. 5
4.2.3 Cleanliness attributes . 6
4.2.4 Special properties . 6
4.3 Intended use . 6
4.4 Consumable use . 7
4.4.1 Single-use . 7
4.4.2 Multiple-use . 7
5 Contaminant of concern . 7
5.1 General . 7
5.2 Emission of contaminants into the air . 7
5.3 Surface contamination by contact transfer . 7
5.4 Surface contamination via liquids. 7
6 Cleanroom suitability assessment prerequisites . 8
6.1 General . 8
6.2 Considerations . 8
6.3 Associated risks . . 8
6.4 Requirements, properties and cleanliness attributes . 8
6.5 Sustainability . 9
7 Customer requirements .9
7.1 General . 9
7.2 Description and intended use . 9
7.3 Requirements for consumable assessment . 9
7.3.1 Functional performance properties. 9
7.3.2 Cleanliness attributes . 10
7.3.3 Special properties . 10
8 Consumable properties as designed by the supplier .11
8.1 General . 11
8.2 Description and designed use . 11
8.3 Consumable properties and attributes . 11
8.3.1 Functional performance properties. 11
8.3.2 Cleanliness attributes . 11
8.3.3 Special properties .12
8.4 Supplier quality documentation .12
9 Assessment . .12
9.1 General .12
9.2 Initial comparison . 13
9.3 Detailed comparison .13
9.4 Cleanroom suitability assessment . 13
9.5 Implementation . .13
10 Documentation .14
10.1 General . 14
iii
ISO 14644-18:2023(E)
10.2 Initial customer’s documentation . 14
10.3 Supplier documentation . 14
10.4 Assessment documentation .15
Annex A (informative) Personal and non-personal consumables .16
Annex B (informative) Impact of consumables on cleanroom cleanliness levels .18
Annex C (informative) Test methods .22
Annex D (informative) Worked examples .29
Bibliography .37
iv
ISO 14644-18:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 14644 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO 14644-18:2023(E)
Introduction
Cleanrooms and associated controlled environments are used for the control of contamination to levels
appropriate for performing contamination-sensitive activities.
Products and processes that benefit from the control of contamination include those in industries such
as aerospace, microelectronics, optics, displays, nuclear, micro-mechanical devices, consumer goods,
cosmetics and life sciences (e.g. pharmaceuticals, medical devices, food). Contamination control in
the healthcare sector benefits the patients by enabling access to products free of potentially harmful
particles.
Consumables are widely used during preparation and operations in cleanrooms, clean zones or
controlled zones to maintain the air or surface cleanliness level in the cleanroom by shielding a
contamination source or a vulnerable object or by removing contamination from a surface. For
monitoring and testing purposes, consumables can be used for sampling contamination. Consumables
need to be carefully selected and appropriately used in order to maintain cleanliness levels and mitigate
risk for processes and products.
Consumables are used for a limited time only. They do not constitute a part of the final product.
This document addresses the suitability assessment of consumables for use in cleanrooms, clean zones
or controlled zones in respect to contamination in air and on surfaces by:
— particles;
— chemicals;
— microorganisms.
Customers or users need to have the opportunity to assess a given consumable by matching their
intended use requirements with the designed use data of the supplier. This can be supplemented by
additional tests. This match of intended use and designed use is addressed as appropriate use.
Depending on the use case, an impact assessment to determine the kind and acceptable quantity of
contamination from consumables can be derived by benchmarking the requirements with respect to
emission of contaminants.
This document is written for suppliers (manufacturers of consumables or distributors) and customers
(as users of consumables) to assess the cleanroom suitability of consumables.
The cleanroom suitability assessment always has to be accompanied with a description of use, technical
data as required by the nature of the consumable and test results. A sole statement such as “suitable for
cleanroom of classification ISO 5” is not foreseen, due to the variety and complexity of use cases and
the likelihood that a cleanroom suitability assessment would not rely on test data relating solely to
airborne particle emissions.
vi
INTERNATIONAL STANDARD ISO 14644-18:2023(E)
Cleanrooms and associated controlled environments —
Part 18:
Assessment of suitability of consumables
1 Scope
This document gives guidance for assessing personal and non-personal consumables for their
appropriate use in cleanrooms, clean zones or controlled zones, based on product and process
requirements, cleanliness attributes and functional performance properties. The cleanliness attributes
addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles,
microorganisms or pyrogens) is considered as a special property of consumables. Identification of
associated risks are considered.
This document complements cleanroom operation as outlined in ISO 14644-5.
This document gives guidance concerning:
— determination of cleanroom suitability of consumables in general;
— specification of requirements for an intended use of a consumable by the customer with respect to
functional performance, cleanliness attributes and special properties;
— specification of properties for a designed use of a consumable by supplier;
— assessment of a consumable for an appropriate use;
— documentation.
Informative annexes are used to list examples for personal and non-personal consumables, verification
methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom.
Cleaning agents, disinfectants and lubricants are considered as consumables with respect to
their packaging, as their packaging is likely to have cleanliness requirements in common with all
consumables.
This document does not apply to:
— design details of consumables;
— testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip
resistance of flooring;
— health and safety requirements; legal requirements can apply in specific countries;
— cleanability;
— (raw) materials which are added within the production process as ingredients;
— performance or function testing;
— transport containers;
— process media such as gases or liquids;
— the functional performance of cleaning agents, disinfectants and lubricants.
ISO 14644-18:2023(E)
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
by particle concentration
ISO 14644-8:2022, Cleanrooms and associated controlled environments — Part 8: Assessment of air
cleanliness by chemical concentration (ACC)
ISO 14644-9, Cleanrooms and associated controlled environments — Part 9: Assessment of surface
cleanliness for particle concentration
ISO 14644-10:2022, Cleanrooms and associated controlled environments — Part 10: Assessment of surface
cleanliness for chemical contamination
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
air cleanliness by chemical concentration
ACC
quantity of chemical detected in the air, expressed in terms of an ISO-ACC level N, which represents the
maximum allowable concentration of a given chemical species or a group of chemical species
Note 1 to entry: Units: g/m .
Note 2 to entry: This definition does not include macromolecules of biological origin, which are judged to be
particles.
[SOURCE: ISO 14644-8:2022, 3.1.2, modified — Units moved to note to entry.]
3.2
appropriate use
application matching designed use (3.12) and intended use (3.13) within acceptable limits
Note 1 to entry: This use is typically stated by the customer of the consumable (3.9).
3.3
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
[SOURCE: ISO 14644-8:2022, 3.1.1]
3.4
cleanliness
condition not exceeding a specified level of contamination (3.10)
Note 1 to entry: In this document, contamination (3.10) refers to particles, chemicals or viables.
[SOURCE: ISO 14644-14:2016, 3.1, modified — Note to entry added.]
ISO 14644-18:2023(E)
3.5
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes, such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations can also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters can also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.6
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone (3.7) when used as
intended
[SOURCE: ISO 14644-14:2016, 3.3, modified — Note 1 to entry deleted.]
3.7
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes, such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations can also be
specified and controlled.
Note 3 to entry: A clean zone can be a defined space within a cleanroom (3.5) or can be achieved by a separative
device. Such a device can be located inside or outside a cleanroom (3.5).
Note 4 to entry: Other relevant physical parameters can also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.8
compatibility
state of which at least two things are able to exist without adverse effect
Note 1 to entry: All types of contamination (3.10) emitted from the consumables under consideration that could
have an impact on the quality of the product or process shall be taken into account.
3.9
consumable
item for use and disposal, if applicable, within cleanrooms (3.5) and controlled environments
3.10
contamination
unwanted matter in an undesirable location
[SOURCE: ISO 14644-13:2017, 3.4]
ISO 14644-18:2023(E)
3.11
controlled zone
designated space in which the concentration of at least one contamination category (particles, chemical,
biocontamination) in air and on surfaces is controlled and specified and which is constructed and used
in a manner to minimize the introduction and impact of contamination
Note 1 to entry: Levels of cleanliness attributes such as chemical and viable concentrations in the air or
cleanliness in terms of particle, chemical and viable concentrations on surfaces should be specified.
Note 2 to entry: Other relevant parameters may also be controlled as necessary, e.g. temperature, humidity and
pressure, vibration and electrostatic.
Note 3 to entry: A controlled zone can be a defined space within a cleanroom (3.5) or may be achieved by a
separative device. Such a device can be located inside or outside a cleanroom (3.5).
[SOURCE: ISO 14644-15:2017, 3.9, modified — deleted “by class(es)” in Note 1 to entry]
3.12
designed use
application as foreseen for a specified purpose and shelf-life (3.17)
Note 1 to entry: This is typically stated by the manufacturer or supplier of the consumable (3.9).
3.13
intended use
application in accordance with a specified purpose
Note 1 to entry: This is typically stated by a user, customer or third party of the consumable (3.9).
3.14
material
single substance or composite
Note 1 to entry: It can be necessary to provide material in a representative form to enable testing.
[SOURCE: ISO 14644-15:2017, 3.13]
3.15
personal consumable
consumable (3.9) that is worn by a person
3.16
service life
period of time or number of cycles a consumable is suitable for use
Note 1 to entry: Service life is dependent on appropriate use (3.2).
3.17
shelf-life
specified period of time from the date of manufacture of a product to its labelled expiration date
[SOURCE: ISO 18369-1:2017, 3.1.9.10]
3.18
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.
ISO 14644-18:2023(E)
Note 3 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12]
4 Description and cleanroom suitability properties of consumables
4.1 Types of consumables
Consumables consist of 2 types:
a) Personal consumables: consumables worn by personnel, primarily to protect the product and
process from contamination emitted by the wearers, see A.2. Personal consumables can also have
a special function to protect the person wearing them. Fit, function and comfort are important
aspects for personal consumables.
b) Non-personal consumables, see A.3.
In Annex A, examples of typical consumables are described.
4.2 Properties of consumables
4.2.1 General
Consumables are used operationally in a clean controlled environment to both maintain the cleanliness
of this environment and facilitate the product realization process. However, due to their high use
rate, and their proximity to the process and product, consumables can also pose a considerable risk
of contamination with particles, chemicals or material of biological nature, such as microorganisms
or pyrogens. Depending on the type, consumables can be either disposed of after a single use or
reprocessed to the required quality for multiple use within a cleanroom.
In principle, consumables can be selected for three main properties:
a) functional performance properties;
b) cleanliness attributes;
c) special properties.
These properties and attributes can be generic or specific and apply to both types of consumables,
personal or non-personal.
4.2.2 Functional performance properties
Functional properties are the starting point for consumable selection for use in a cleanroom, clean
zone or controlled zone. All necessary functional performance properties for a consumable shall be
considered. The following list can be used as an input for the consideration:
a) cleaning properties;
b) sorption;
c) physical properties;
d) chemical compatibility;
e) breathability, if applicable;
f) barrier protecting the cleanroom or controlled environment or process;
g) barrier protecting personnel;
ISO 14644-18:2023(E)
h) application of liquids to surfaces;
i) surface protection;
j) abrasion resistance.
4.2.3 Cleanliness attributes
Cleanliness attributes address the contaminant of concern and how the implementation of a personal
or non-personal consumable affects the overall cleanliness level when being used in a cleanroom or
controlled environment. In order to be able to assess the cleanroom suitability of a consumable, it has
to be specified which contaminants, such as particles, fibres, chemicals and microorganisms, are of
interest. Therefore, the cleanliness attributes shall be captured at least by:
a) contaminant of concern (see Clause 5);
b) maximum concentration of contaminant(s) of concern at observed airflow conditions;
c) transfer of contamination (direct or indirect).
Biocontamination can be addressed as a special property, either as sterility or bioburden (number of
contaminants and species). In addition, pyrogens can be assessed as applicable.
4.2.4 Special properties
Examples of special properties related to cleanroom suitability are:
a) antistatic or static dissipative properties;
b) supply chain management and logistics:
1) quality management systems;
2) batch or lot information or certification(s);
c) biocontamination sensitive processes:
1) specific sterilization methods, packaging marking, etc.;
2) material compatibility with sterilization processes;
3) bioburden or sterility;
4) pyrogens;
5) cleaning or disinfecting consumables;
i) particle filtration;
ii) residue requirements;
d) appearance and texture (e.g. woven or non-woven);
e) dry or wet used;
f) recycling.
4.3 Intended use
The intended use shall be documented by the customer along with the consumable description. It shall
take into consideration functional performance properties, cleanliness attributes and special properties,
if applicable. A clear description of the intended use enables selection of the most suitable consumable(s)
ISO 14644-18:2023(E)
for assessment. If known, reference should be made to the corresponding ISO classification of the
controlled environment, including the cleanroom ventilation in which the consumable will be used.
4.4 Consumable use
4.4.1 Single-use
Single-use consumables are designed to be used once and then disposed of. Regarding disposal, the
consumable should be designed to be recyclable, wherever feasible. Single-use consumables are used at
a discrete process stage or for a specified period and then discarded. A consumable is typically single-
use.
4.4.2 Multiple-use
Multiple-use consumables are designed to be used multiple times for a limited period of time and then
disposed of. Regarding disposal, the consumable should be designed to be recyclable, wherever feasible.
Multiple-use consumables are capable of being reprocessed and, when required, resterilized in order to
be used again. When deciding for multiple-use, a full life cycle assessment can be applied to identify a
good sustainable option.
The reprocessing shall ensure that the consumable continues to meet the functional, cleanliness and
special requirements through periodic evaluation or testing. The number of reprocessing cycles that
the consumable can undergo shall be specified and monitored. Ongoing conformity to requirements
and reprocessing cycles shall be documented.
5 Contaminant of concern
5.1 General
A consumable can cause contamination by particles (including microorganisms), pyrogens or chemicals
contamination by emission into the air of the controlled environment or onto a surface, either by
contact transfer or deposition. Annex B provides methods that can be used to estimate the acceptable
contamination from a consumable.
Contamination within a consumable or on its surface can be transferred into a liquid and by subsequent
deposition can remain as a residue on a surface.
5.2 Emission of contaminants into the air
Particles as defined in ISO 14644-1 or larger particles as addressed in ISO 14644-17 can be emitted
from the consumable by various mechanisms. Units and concentrations can be found in ISO 14644-1.
Chemical species as defined in ISO 14644-8 can be emitted from the consumable by various mechanisms.
Examples of chemical species and concentrations can be found in ISO 14644-8.
5.3 Surface contamination by contact transfer
A consumable can transfer particles or chemicals onto surfaces in the cleanroom by contact. Units,
chemical species and concentrations can be found in ISO 14644-9 and ISO 14644-10.
5.4 Surface contamination via liquids
Consumables can contaminate liquids with particles or chemicals. Contaminated liquids can create
contaminated surfaces. Examples for chemicals can be found in ISO 14644-10.
ISO 14644-18:2023(E)
6 Cleanroom suitability assessment prerequisites
6.1 General
This clause describes the steps and considerations that need to be taken by a customer and a supplier
to facilitate a cleanroom suitability assessment of a consumable. Documented data gathered during this
activity enables an effective comparison-based assessment. A consumable can then be selected on the
basis of its cleanroom suitability for an intended use case.
This clause does not address the numerous formal risk and hazard quality assessment methods
available. It is intended to highlight considerations that could negatively affect the cleanroom suitability
assessment of a consumable, should they be ignored.
6.2 Considerations
The customer shall provide requirements of the consumable, taking into consideration 4.1 to 4.4 and
Clause 5, together with an explanation of its intended use. Typical customer requirements for the
consumable are described in Clause 7.
The supplier shall provide, upon request, a description and data for the designed use of the consumable,
e.g. functional performance properties and cleanliness attributes. This information is usually made
available in data sheets.
6.3 Associated risks
For any cleanroom suitability assessment, the user shall consider making a judgement regarding how
critical the required consumable is to its cleanroom or controlled environment and product quality.
This risk-based judgement can influence the depth of requirements gathering and the rigour of the
assessment, plus the need for any subsequent verification activity, should the comparison-based
assessment alone be judged to be insufficient. This judgement can be updated following the cleanroom
suitability assessment, and prior to deployment of the consumable, as it can influence the scale of any
final verification activity.
Separately, when mitigating personal safety hazards, the design of the personal protective equipment
(PPE) consumable can present an associated contamination source. The selection of a consumable
for its PPE function shall also include an evaluation of the potential for contamination with regard to
its intended use. This evaluation can lead to measures to minimize the impact of this contamination
source.
6.4 Requirements, properties and cleanliness attributes
For the intended use of a consumable, customers shall specify their requirements for:
a) functional performance properties;
b) cleanliness attributes;
c) special properties.
The specification shall follow Clause 7.
NOTE It is expected that the more critical a consumable is to the cleanroom or controlled environment, the
more comprehensive the requirements and the related documentation.
Suppliers provide information on a consumable’s properties as outlined in Clause 8 to allow a
comparison between customer requirements and supplier data provided. Should additional data be
required for the customer’s cleanroom suitability assessment, the supplier can provide this data, if
readily available. Alternatively, new data can be created by testing the consumable specifically.
ISO 14644-18:2023(E)
The final assessment of cleanroom suitability (see Clause 9) is a comparison of information provided by
the customer (Clause 7) and supplier (Clause 8).
6.5 Sustainability
Due to their high usage volumes and predominance of single-use, organizations involved within the
creation, distribution and use of consumables shall address sustainability and thereby reduce their
environmental impact.
a) Manufacturers should implement a formal environmental management programme that addresses
impact mitigation ranging from energy and waste reduction to resource conservation generally
and finally optimum materials selection and recycling.
b) Companies involved in the distribution of consumables should address waste and energy reductions
via efficient logistics. Furthermore, they should enable material returns processes.
c) User companies should follow a formal environmental management programme. All users should
segregate waste materials at source to enable either material repurposing or recycling. Recycling
initiatives should also be enabled via the upstream supply chain (design for recyclability).
d) The sustainability of a consumable should be considered using a holistic approach. From production,
reprocessing, use to final disposal or recycling.
7 Customer requirements
7.1 General
To enable the subsequent comparison assessment for cleanroom suitability of a consumable, gathering
and documenting the customer (user) requirements is a key step. The content o
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