EN ISO 14644-5:2004

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2004)

Dieser Teil von ISO 14644 legt grundlegende Anforderungen an den Betrieb von Reinräumen fest. Er richtet sich an alle, die die Nutzung und den Betrieb eines Reinraums planen. Sicherheitsaspekte, die keinen direkten Bezug zur Kontaminationskontrolle haben, werden in diesem Teil von ISO 14644 nicht berücksichtigt. Landesspezifische und örtliche Sicherheitsbestimmungen sind ebenso einzuhalten. Diese Norm behandelt  alle Klassen von Reinräumen, die zur Herstellung der verschiedensten Produkte eingesetzt werden. Dieses Dokument ist daher auf eine breite Anwendung ausgelegt und geht daher auf besondere Anforderungen für einzelne Industriezweige nicht ein. Verfahren und Programme zur laufenden Überwachung im Reinraum werden in diesem Teil von ISO 14644 nicht im Einzelnen behandelt; hinsichtlich der Überwachung von Partikeln wird auf ISO 14644-2 und ISO 14644-3 und hinsichtlich der Überwachung von Mikroorganismen auf ISO 14698-1 und ISO 14698-2 verwiesen.

Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO 14644-5:2004)

L'ISO 14644-5:2004 spécifie les exigences de base pour l'exploitation des salles propres. Elle s'adresse aux personnes qui envisagent d'utiliser et d'exploiter une salle propre. Les aspects de sécurité qui ne concernent pas directement la maîtrise de la contamination ne sont pas pris en compte dans l'ISO 14644-5:2004. Les réglementations nationales ou locales en matière de sécurité doivent être respectées. Le présent document s'applique à toutes les classes de salles propres utilisées pour la production de tous les types de produits. Le présent document a donc un vaste domaine d'application et n'aborde pas les exigences particulières de telle ou telle industrie en particulier. Les méthodes et les programmes de surveillance régulière dans les salles propres ne sont pas abordés de manière détaillée dans l'ISO 14644-5:2004. Il convient cependant de se référer à l'ISO 14644-2 et à l'ISO 14644-3 pour la surveillance des particules, ainsi qu'à l'ISO 14698-1 et à l'ISO 14698-2 pour la surveillance des micro-organismes.

Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO 14644-5:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-Aug-2004
• Withdrawal Date: 22-Sep-2025
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Jun-2025
• Completion Date: 23-Sep-2025
• Ref Project: SIST EN ISO 14644-5:2005 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)

Relations

• Replaced By: EN ISO 14644-5:2025 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)
• Effective Date: 13-Dec-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2005
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO'HORYDQMH,62
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-
5:2004)
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2004)
Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO
14644-5:2004)
Ta slovenski standard je istoveten z: EN ISO 14644-5:2004
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.

EUROPEAN STANDARD
EN ISO 14644-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2004
ICS
English version
Cleanrooms and associated controlled environments - Part 5:
Operations (ISO 14644-5:2004)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 5:
Partie 5: Exploitation (ISO 14644-5:2004) Betrieb (ISO 14644-5:2004)
This European Standard was approved by CEN on 29 July 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-5:2004: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 14644-5:2004) 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 February 2005, and conflicting national
standards shall be withdrawn at the latest by February 2005.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 14644-5:2004 has been approved by CEN as EN ISO 14644-5:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 14644-5
First edition
2004-08-15
Cleanrooms and associated controlled
environments —
Part 5:
Operations
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
Reference number
ISO 14644-5:2004(E)
©
ISO 2004
ISO 14644-5:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Specification of requirements . 3
Annex A (informative) Operational systems. 7
Annex B (informative) Cleanroom clothing. 13
Annex C (informative) Personnel . 18
Annex D (informative) Stationary equipment. 22
Annex E (informative) Materials and portable equipment . 26
Annex F (informative) Cleanroom cleaning . 33
Bibliography . 43

ISO 14644-5:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14644-5 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
 Part 1: Classification of air cleanliness
 Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
 Part 3: Test methods
 Part 4: Design, construction and start-up
 Part 5: Operations
 Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
 Part 8: Classification of airborne molecular contamination
The following part is under preparation:
 Part 6: Terms and definitions

iv © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
Introduction
Industries and organizations of all kinds utilize cleanrooms. Operational procedures have a profound effect on
the cleanliness levels achieved during the operation of the cleanroom and equipment. Consistent quality is
cleanliness dependent. Operational cleanliness can only be attained and maintained through a deliberate
programme established to specify, measure and enforce defined operational procedures. Regulatory agencies
that have authority over processes and products produced in the cleanroom may require additional
procedures and measures of cleanliness not covered in this general operating standard.
This part of ISO 14644 addresses normative and informative operational requirements related to:
a) providing a system that defines policies and operational procedures;
b) clothing used to isolate human-generated contamination from the cleanroom environment;
c) training of personnel inside the cleanroom and monitoring their compliance to specified procedures and
disciplines;
d) transfer, installation and maintenance of stationary equipment (selection criteria is not discussed);
e) selection and use of materials and portable equipment in the cleanroom;
f) maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures.

INTERNATIONAL STANDARD ISO 14644-5:2004(E)

Cleanrooms and associated controlled environments —
Part 5:
Operations
1 Scope
This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning
to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are
not considered in this part of ISO 14644 and national and local safety regulations must be observed. This
document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in
application and does not address specific requirements for individual industries. Methods and programmes for
routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made
to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring
micro-organisms.
2 Normative references
The following referenced documents are indispensable for the application 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 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing
and monitoring to prove continued compliance with ISO 14644-1
1)
ISO 14644-3:— , Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control —
Part 1: General principles and methods
ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control —
Part 2: Evaluation and interpretation of biocontamination data

1) To be published.
ISO 14644-5:2004(E)
3 Terms and definitions
For the purposes of this part of ISO 14644, the following terms and definitions apply.
3.1 General Terms
3.1.1
biocleanroom
cleanroom used for products and processes that are sensitive to microbiological contamination
3.1.2
changing room
room where people entering or leaving a cleanroom put on or take off cleanroom clothing
NOTE Adapted from ISO 14644-4:2001, 3.1.
3.1.3
cross-over bench
bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to the tracking of
floor contamination
3.1.4
disinfection
removal, destruction or de-activation of micro-organisms on objects or surfaces
3.1.5
fibre
particle having an aspect (length-to-width) ratio of 10 or more
[ISO 14644-1:1999, 2.2.7]
3.1.6
operator
person working in the cleanroom performing production work or carrying out process procedures
3.1.7
particle
minute piece of matter with defined physical boundaries
NOTE For classification purposes refer to ISO 14644-1:1999.
3.1.8
personnel
persons entering the cleanroom for any purpose
3.1.9
separative device
equipment utilizing constructional and dynamic means to create assured levels of separation between the
inside and the outside of a defined volume
EXAMPLES Some industry-specific examples of separative devices are clean air hoods, containment enclosures,
gloveboxes, isolators and minienvironments.
3.1.10
unidirectional airflow
controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately
parallel airstreams
NOTE This type of airflow results in a directed transport of particles from the clean zone.
[ISO 14644-4:2001, 3.11]
2 © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
3.2 Occupancy states
3.2.1
as-built
condition where the installation is complete with all services connected and functioning but with no production
equipment, materials or personnel present
[ISO 14644-4:2001, 2.4.1]
3.2.2
at-rest
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 14644-4:2001, 2.4.2]
3.2.3
operational
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 14644-4:2001, 2.4.3]
4 Specification of requirements
4.1 Operational systems
4.1.1 A system of operational procedures shall be established and documented that will provide a
framework for producing the quality products and processes for which the cleanroom was designed.
4.1.2 A set of risk factors, appropriate for the use of the cleanroom, shall identify the areas where there is a
risk of contamination to the process. A method for monitoring these risks shall be instituted so that action can
be taken when conditions violate the contamination limits for the cleanroom classification.
NOTE Although not covered in detail in this part of ISO 14644, it is important to routinely monitor the operation of a
cleanroom. Guidance for monitoring particles is given in ISO 14644-2 and ISO 14644-3. Guidance for monitoring
biocontamination is given in ISO 14698-1 and ISO 14698-2.
4.1.3 A system for training personnel in cleanroom procedures shall be instituted. A method for monitoring
compliance to those training procedures shall be specified.
4.1.4 A documentation system shall be maintained to provide evidence that all personnel have received
suitable levels of training for their assignments.
4.1.5 A set of procedures shall be documented to describe how the cleanroom mechanical systems are to
be operated, maintained, repaired and monitored (see ISO 14644-4).
4.1.6 All activities that modify, supplement or enlarge the cleanroom shall be planned and include all
relevant personnel. Any significant change of operational use may be subject to re-qualification of the
installation in compliance with ISO 14644-2.
4.1.7 A system shall be documented that encourages and enforces safety for personnel in the cleanroom
that may influence aspects of contamination control.
NOTE Informative guidance concerning the operational systems requirements listed in 4.1.1 to 4.1.7 can be found in
Annex A.
ISO 14644-5:2004(E)
4.2 Cleanroom clothing
4.2.1 Cleanroom clothing shall protect the environment and products from contamination generated by the
personnel and their everyday clothing. To maximize this containment, the choice of barrier fabric, the clothing
style and extent of coverage of personnel by the cleanroom clothing shall be established.
4.2.2 Cleanroom clothing shall be made of fabrics and materials that will resist breakdown (minimal linting)
and therefore not shed contamination.
4.2.3 The frequency of changing into fresh cleanroom clothing before entering the cleanroom shall be
determined in accordance with the product and process cleanliness requirements.
4.2.4 Reusable cleanroom clothing shall be processed at regular intervals to remove contamination.
4.2.5 The necessary cleaning, processing (including sterilization or disinfection where required) and
packaging of clothing shall be defined.
4.2.6 Cleanroom clothing shall be transported and stored in a specified manner to minimize contamination.
4.2.7 Cleanroom clothing (clean packaged or dirty) shall not be removed beyond the confines of the storage
area and cleanroom except for laundering, repair or exchange purposes.
4.2.8 Cleanroom clothing shall be put on and taken off in such a way that the spread of contamination is
avoided or minimized.
4.2.9 If clothing is to be reused, it shall be removed and stored to ensure that contamination is minimized.
4.2.10 Cleanroom clothing shall be checked at regular intervals to ensure that it retains acceptable
contamination control characteristics.
4.2.11 Consideration shall be given for the comfort of personnel wearing the cleanroom clothing.
4.2.12 Consideration shall be given to special (e.g. chemical, physical or microbiological) properties of the
clothing that may be necessary for specific applications.
4.2.13 Consideration shall be given to special concerns for cleanroom clothing during and after emergency
evacuations.
NOTE Informative guidance concerning cleanroom clothing requirements listed in 4.2.1 to 4.2.13 can be found in
Annex B.
4.3 Personnel
4.3.1 Personal and other items not intended for cleanroom use shall not be allowed inside the cleanroom,
unless approved.
4.3.2 Personnel shall be instructed in hygiene-related issues that will prepare them for properly working in
the cleanroom environment.
4.3.3 A policy concerning jewellery, cosmetics and similar materials that can cause contamination problems
shall be determined.
4.3.4 Cleanroom personnel shall be trained to conduct themselves in a manner that minimizes generation
of contamination which can be transferred or deposited on or into the product.
4.3.5 Personnel shall be protected against hazards. Personnel shall receive safety training for all known
health and safety risks associated with their work.
NOTE Informative guidance concerning personnel requirements listed in 4.3.1 to 4.3.5 can be found in Annex C.
4 © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
4.4 Stationary equipment
4.4.1 All equipment, with its associated moving and rigging equipment, shall be thoroughly cleaned or
decontaminated, or both, before being transported into the cleanroom environment.
4.4.2 Procedures relating to the entry of equipment into a controlled environment shall be specified to
ensure that all equipment undergoes the necessary cleaning and decontaminating.
4.4.3 Installation of equipment shall be planned and carried out to minimize the impact on the cleanroom
environment.
4.4.4 Equipment maintenance, repairs and calibration procedures shall be performed in such a way as to
control and minimize contamination of the cleanroom.
4.4.5 Documented procedures relating to maintenance work and repairs shall be specified to control
contamination.
4.4.6 Preventive maintenance schedules shall be established and timed to renew and replace components
before the components become contamination sources.
NOTE Informative guidance concerning stationary equipment requirements listed in 4.4.1 to 4.4.6 can be found in
Annex D.
4.5 Materials and portable and mobile equipment
4.5.1 All materials, as well as portable and mobile equipment, shall be appropriate for the level of
cleanroom cleanliness, and in use, shall not compromise the product and process.
4.5.2 Procedures shall be established to ensure materials and portable and mobile equipment entering the
cleanroom are not contaminated.
4.5.3 Procedures shall be established to minimize the quantities of materials stored in the cleanroom.
Consideration shall be given to shelf-life limitations, if applicable.
4.5.4 Materials stored in the cleanroom shall be subject to defined procedures and, where necessary, shall
be held in protective storage or isolation. The risk of contamination arising from the storage and subsequent
use of materials and portable and mobile equipment in the cleanroom shall be considered.
4.5.5 All used and waste materials shall be collected, identified and removed in accordance with defined
procedures. Waste materials shall be removed frequently and in a manner that does not compromise the
cleanliness of the product or process. Procedures for hazardous materials must conform to statutory
requirements set by local and other regulatory agencies.
NOTE Informative guidance concerning materials and portable equipment requirements listed in 4.5.1 to 4.5.5 can be
found in Annex E.
4.6 Cleanroom cleaning
4.6.1 Cleaning methods and procedures shall be specified and routinely followed to maintain cleanroom
surfaces at acceptable cleanliness levels.
4.6.2 Personnel responsible for the cleaning operation shall be designated and receive specific training for
accomplishing the task.
4.6.3 Cleaning schedules shall be defined and carried out at effective frequencies to ensure that specified
cleanliness levels are maintained.
4.6.4 Appropriate contamination checks shall be carried out on a routine basis to ensure the cleanroom is
maintained at specified levels.
ISO 14644-5:2004(E)
4.6.5 An assessment shall be made to identify any cleaning procedures that will place products or
processes at risk during the performance of such cleaning tasks. Preparations should be made to remove or
cover work-in-process before cleaning begins.
4.6.6 Special cleaning procedures and techniques shall be defined for unavoidable accidents or system
failures that create contamination that places the cleanroom, products, processes or personnel at risk.
NOTE Informative guidance concerning cleaning requirements listed in 4.6.1 to 4.6.6 can be found in Annex F.
6 © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
Annex A
(informative)
Operational systems
A.1 General
It is essential that management provides leadership that will focus the attention of its staff on generating and
maintaining systems that will encourage good cleanroom practices. A management structure should be
defined and published to ensure all parties are aware of their responsibilities. Good cleanroom practices will
have a significant impact on the quality of products being produced and the processes performed in the
cleanroom. This annex is provided to assist management in identifying those systems.
A.2 Assessing contamination risks
A.2.1 Methods for assessing risks
A risk assessment should be made to determine any relevant contamination control factors that may affect the
products or processes performed in the cleanroom.
Some examples of methods used for determining and managing these factors include:
[1]
a) HACCP (Hazard Analysis Critical Control Point) ;
[2][3]
b) FMEA (Failure Mode Effects Analysis) ;
[4]
c) FTA (Fault Tree Analysis) .
A.2.2 Determining operational risks
A.2.2.1 General
Improper control of the critical elements of an operational cleanroom can pose a risk to the cleanliness of the
cleanroom and the quality of the product. A list of these critical elements and some of the associated risks can
be found beginning in A.2.2.2 to A.2.2.6. An assessment of these risks should be carried out and plans
formulated by each organization to remedy non-compliant situations. In this assessment, it is especially
important to consider the following:
a) concentration of contamination in or on the risk factor;
b) distance from the risk to the product;
[5]
c) importance of the method used to protect product from the risk .
Information concerning cleanroom support parameters and factors including heating, ventilation and air
conditioning functions, pressure, temperature, humidity, air change failure and filter failure are discussed in
ISO 14644-2, ISO 14644-3 and ISO 14644-4.
ISO 14644-5:2004(E)
A.2.2.2 Cleanroom clothing
Risk factors that may influence the operation or environmental quality of the cleanroom include:
a) required human containment (coveralls, frocks, hoods, gloves, boots, masks, etc);
b) material performance (weave characteristics, filament types, sterility, antistatic, calendering, etc);
c) design and construction (special tailoring requirements);
d) comfort;
e) usage (launderable versus disposable);
f) choice of personal clothing worn under cleanroom clothing;
g) time interval or number of wearings before laundering is required;
h) choice of cleanroom clothing laundry;
i) renewing, packaging, storage and distribution.
A.2.2.3 Personnel
Risk factors that may influence the operation or environmental quality of the cleanroom include:
a) selection of personnel;
b) education and training;
c) safety (including emergency procedure);
d) personal attire, hygiene and behaviour, (including behaviour prior to entering the cleanroom);
e) chronic and acute medical conditions;
f) personnel who shed significantly more contamination than other personnel;
g) who is allowed to enter;
h) special procedures for visitors;
i) maximum occupancy;
j) entry and exit procedures;
k) movement and activity of personnel within the cleanroom.
A.2.2.4 Stationary equipment
Risk factors that may influence the operation or environmental quality of the cleanroom include:
a) entry and exit procedures;
b) installation;
c) cleaning techniques;
d) contamination generation;
8 © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
e) generation of heat, humidity and electrostatic charge;
f) maintenance and repair;
g) cleanliness of process material and utilities delivery systems;
h) potential equipment failures.
A.2.2.5 Materials and portable and mobile equipment
Risk factors that may influence the operation or environmental quality of the cleanroom include:
a) compatibility and selection;
b) entry, exit and movement procedures;
c) storage factors while in the cleanroom;
d) contamination factors during use;
e) generation of electrostatic charges;
f) liquid and gas purity supplied by delivery systems;
g) waste disposal;
h) packaging.
A.2.2.6 Cleanroom cleaning
Risk factors that influence the operation or environmental quality of the cleanroom may include:
a) routine environmental contaminating factors (airflows, airborne particles, out-gassing, hazardous gas,
micro-organisms, vibration, electrostatic charges, molecular contamination, etc.);
b) personnel and material flow;
c) service, maintenance and repair;
d) cleaning methodology;
e) emergency and planned shutdown;
f) facility expansion and modification;
g) frequency for monitoring the results of cleaning.
A.3 Monitoring and corrective action
A routine monitoring programme should be followed that encompasses personnel, cleaning and other
operational systems. Monitoring should be sufficiently frequent and comprehensive to detect actual or
emerging unacceptable conditions in a timely manner. Exceeding specified action levels should result in a
prompt response, including investigative and corrective action. Investigative and corrective action should
include the effect on product quality as a potential result of the non-compliant condition. Further information
can be found in ISO 14644-2 and ISO 14644-3 for particle monitoring. Information on microbiological
monitoring can be found in ISO 14698-1 and ISO 14698-2.
ISO 14644-5:2004(E)
A.4 Education and training
A.4.1 Involvement
General personnel activity within the cleanroom has a profound effect on the integrity of the clean
environment. Failure to properly train anyone entering, using or maintaining the facility will compromise the
effectiveness of the cleanroom. Management is therefore responsible for implementing a comprehensive
programme to train all personnel with regard to their responsibilities and how those responsibilities interact
with the clean environment. Certification should be based on successful completion of testing to demonstrate
understanding and compliance. The programme should ensure each of the following groups of personnel is
educated and trained appropriately:
a) operators;
b) technicians;
c) engineers and scientists;
d) quality assurance personnel;
e) supervisors and managers;
f) facilities personnel;
g) contractors;
h) field service personnel;
i) visitors.
A.4.2 Training course contents
Subjects that can be included in the training course include:
a) how the cleanroom works (design, airflow and air filtration);
b) cleanroom standards;
c) sources of contamination;
d) personal hygiene;
e) cleaning;
f) cleanroom clothing procedures;
g) maintenance procedures;
h) how a cleanroom is tested and monitored;
i) how to act in a cleanroom;
j) explanation of the work process, technologies or sciences employed and how the process can become
contaminated;
k) safety and emergency response.
A.4.3 Monitoring of cleanroom personnel and corrective action
The cleanroom training programme provides an explanation of requirements and actions that minimize the risk
factors important to the cleanroom, identified in A.2.2.3. The ability of personnel to incorporate all elements of
10 © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
cleanroom training into practice is essential to the continuous, effective operation of the cleanroom.
Personnel, although properly trained, may not fully comprehend all requirements or may lapse into poor
procedural habits. Therefore, actions of personnel listed in A.4.1 should be monitored to ensure personnel
carefully comply with correct cleanroom disciplines. Consideration should be given to a system that will
monitor cleanroom personnel. Monitoring programmes can be formal or informal depending on the level of
empowerment given to each person that is part of the cleanroom staff. Internal auditors can monitor the
actions of those in the cleanroom based upon the written procedures. Reports can be issued to management
[6]
on a regular basis detailing unsatisfactory behaviour and can be used for determining corrective action .
An effective programme should be a positive influence on all personnel to follow proper cleanroom
procedures.
A.4.4 Training documentation
A concise, comprehensive system that documents the training progression and level of each individual
associated with cleanroom operation and maintenance should be used. The management team should
identify each job and set of jobs or responsibilities. This documentation system should be easily accessible to
management and periodically reviewed. Basic documentation should include course contents, personnel
identification information, training and certification dates, and schedules for retraining that may be required at
future intervals.
A.5 Cleanroom support services
A.5.1 General overview
Management is responsible for ensuring cleanroom support services consistently function as designed on a
day-to-day basis. Support services may include clean and conditioned air systems, compressed air and
gasses, water and other utilities, and other aspects required for standard cleanroom operation. Failure of any
mechanical support system can seriously affect the cleanliness and operation of the cleanroom. Records and
procedures documenting the operation of the systems that provide and maintain the cleanroom should be
readily available. Some of the information required to establish such systems is given in A.5.1 to A.5.6. More
thorough coverage of the subjects listed in A.5.2 to A.5.6 is found in ISO 14644-4.
A.5.2 Record of the installation
This record should contain installation drawings, cleanroom classification including acceptance test results to
original specifications, and recommended spare parts lists.
A.5.3 Operating and maintenance instructions
Operating and maintenance instructions should include an explanation of how the systems work and their
influence on room cleanliness. The mechanical and electrical systems within the installation should have a
clear set of operating and maintenance instructions. These instructions should describe procedures used to
check and inspect all critical components prior to start-up. Emergency shutdown procedures and start-up
procedures after unplanned shutdowns should be documented.
A.5.4 Performance monitoring
Performance monitoring of the installation is essential to demonstrate satisfactory operation. Documented
schedules and procedures that specify the required tests and the frequency of testing are needed to
demonstrate specified cleanroom classifications. Action plans for non-compliant situations should be defined.
A.5.5 Maintenance procedures
Unplanned downtime can adversely affect productivity and introduce contamination to the cleanroom.
Ongoing performance checks and preventive maintenance should be performed to minimize contamination
ISO 14644-5:2004(E)
that may be caused by unanticipated equipment failures. Repair and maintenance procedures should contain
precautions that will help minimize and contain contamination. Tests may also be necessary to ensure that
reactivated equipment is clean and in specification before being accepted for reuse.
A.5.6 Maintenance records
Evidence of effective maintenance requires a documented record involving all maintenance activities. Problem
diagnoses, parts replaced, dates, times and personnel performing the maintenance should be documented.
Preventive maintenance schedules and charts should be updated as required. Periodic analysis of such
records may help in making improvements to the programme and help optimize preventive maintenance
schedules.
A.6 Upgrading and modifying the cleanroom
All upgrades or modifications, including the addition of stationary equipment and changes to floor plans, can
affect the cleanliness of the cleanroom. Management should make certain these changes are planned and
carried out in a controlled and thorough manner and that requalification of the installation is in compliance with
ISO 14644-2 and ISO 14644-4. A record of all changes or modifications should be documented after
requalification. All appropriate personnel with responsibilities affected by these changes should be involved
and kept informed of progress. Such personnel may include but are not limited to:
a) facility engineers;
b) manufacturing engineers;
c) equipment engineers;
d) contamination control engineers;
e) process engineers and scientists;
f) quality assurance engineers and scientists;
g) manufacturing managers;
h) contractors.
A.7 Safety
Normal operation of cleanroom facilities often includes the use of hazardous, toxic or infectious materials.
Preventive measures required by statutory regulations must be observed to protect personnel from exposure
to these agents. Management should implement and monitor effective systems for protecting the health and
welfare of personnel. Good programmes should include the following:
a) centralized, readily-available safety data sheets that describe hazardous materials;
b) evacuation plans and practice evacuations;
c) accident reporting system;
d) feedback suggestion systems for personnel;
e) appropriate monitoring of potentially hazardous conditions or materials;
f) rapid response to emergencies by trained personnel;
g) documentation that supports improvements and corrections to safety-related issues.
12 © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
Annex B
(informative)
Cleanroom clothing
B.1 Function of cleanroom clothing
Personnel disperse fragments from their skin and particles from their indoor, non-cleanroom clothing. This
airborne dispersion will vary from person to person and from time to time but can be several million particles
per minute and several hundred bacteria-carrying particles per minute. The prime function of cleanroom
clothing is to act as a barrier filter that protects product and process from human contamination. Therefore,
cleanroom clothing should be made from a fabric that filters the dispersed contamination. Cleanroom clothing
should also be designed to envelop a person and not allow significant amounts of unfiltered body emissions to
be dispersed into the cleanroom. An effective cleanroom undergarment in combination with cleanroom
clothing can provide an additional reduction in dispersion.
Although the majority of contamination originates from the skin and non-cleanroom clothing, contamination is
also dispersed from the surface of cleanroom clothing fabrics. The fabric used to manufacture cleanroom
clothing should not add to the contamination burden.
Personnel also emit inert and microbe-carrying particles from the mouth through sneezing, coughing and
talking. Therefore, cleanroom clothing should be made from a fabric that filters the contamination dispersed.
Touching will transmit contamination from the hands to surfaces in the cleanroom. Depending on the
cleanroom function and class, it may be necessary to wear face masks, helmets and gloves to minimize
transmission of these types of contamination. The choice of cleanroom clothing will vary according to the
product cleanliness and process requirements but will normally, but not exclusively, consist of hoods, caps,
helmets, coveralls, overboots, face masks and goggles or safety glasses.
B.2 General choice of cleanroom clothing
The best design of cleanroom clothing will completely envelop the person and have good closures at the wrist,
neck and ankle. The choice will depend on the class of cleanroom but cleanrooms with higher cleanliness
requirements are typified by a one-piece coverall, overboots and a hood with yoke or skirt that tucks under the
[8]
neck of the garment. Increasing technical requirements on cleanroom clothing may result in increasing
personal restrictions or discomfort. Therefore, consideration should be given to what is necessary for the
standard of room cleanliness. Where cleanliness and process requirements permit, clothing of lesser
[7] [8] [9] [10]
coverage may be acceptable . Certain separative devices with built-in clean air systems (e.g mini-
environments or isolators) may allow for the simplification of required cleanroom clothing.
There are two broad categories of clothing used in cleanrooms: 1) disposable (or limited use) and 2) reusable.
In general, disposable or limited use clothing usually is made from a non-woven materials and is used either
once or a few times, and then discarded. Reusable cleanroom clothing is processed at regular intervals and
usually made from tightly woven synthetic fabrics, constructed with lint-free, continuous filament materials
(such as polyester or polyamide). Natural fabrics made from fibres, such as cotton, would not normally be
used in cleanrooms as they easily break up and disperse contamination. More critical applications may require
the use of membrane barrier technology, which may be either disposable or reusable.
ISO 14644-5:2004(E)
B.3 Properties of fabric
B.3.1 Barrier properties
The fabric used in cleanroom clothing should prevent personnel-generated contamination from being
dispersed into the cleanroom. Woven fabric acts as a filter; effectiveness is related to the tightness of the
weave of the fabric. In the case of barrier-type fabrics such as non-wovens and laminate membranes, the
effectiveness to contain contamination is a function of the barrier characteristics. Fabric effectiveness can be
[8] [10] [11] [12]
assessed by a measurement of air permeability, particle retention and pore size . As air
permeability decreases, there is a corresponding increase in pressure within the garment as personnel move
about. This can result in an outward pumping action of unfiltered air through the closures of the cleanroom
clothing.
B.3.2 Durability
Cleanroom clothing should be resistant to breakdown and tearing. The fabric should disperse the minimum of
[7] [10] [13] [14]
particles. Information is available on tests used to assess these types of fabric properties .
B.3.3 Electrostatic properties
In some types of cleanrooms (e.g. microelectronics or rooms with flammable or explosive chemicals), the
electrostatic charges that build up on the surface of clothing will be harmful to the components being
manufactured or hazardous to operators. Fabrics are available with woven-in, static-dissipative threads to
discharge any induced voltage potentials on the fabric surface. The effectiveness of a fabric to dissipate an
electrostatic charge can be indirectly measured by checking the fabric’s surface resistivity. Such methods are
[10] [15] [16]
described in other sources . In a more effective test, a static charge of known voltage level is
applied to the fabric. Static dissipative performance can then be determined by the time it takes for the vo
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