SIST EN ISO 14644-5:2025

SLOVENSKI STANDARD
01-september-2025
Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO 14644-5:2025)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-
5:2025)
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2025)
Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO
14644-5:2025)
Ta slovenski standard je istoveten z: EN ISO 14644-5:2025
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 14644-5
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-5:2004
English Version
Cleanrooms and associated controlled environments - Part
5: Operations (ISO 14644-5:2025)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 5:
- Partie 5: Exploitation (ISO 14644-5:2025) Betrieb (ISO 14644-5:2025)
This European Standard was approved by CEN on 25 May 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-5:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-5:2025) 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 December 2025, and conflicting national standards
shall be withdrawn at the latest by December 2025.
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.
This document supersedes EN ISO 14644-5:2004.
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 14644-5:2025 has been approved by CEN as EN ISO 14644-5:2025 without any
modification.
International
Standard
ISO 14644-5
Second edition
Cleanrooms and associated
2025-05
controlled environments —
Part 5:
Operations
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
Reference number
ISO 14644-5:2025(en) © ISO 2025

ISO 14644-5:2025(en)
© ISO 2025
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 14644-5:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Abbreviations . 4
5 General . 4
6 Impact assessment . 5
7 Operations Control . 6
7.1 General .6
7.2 Operations control programme .6
7.2.1 General .6
7.2.2 Elements of the OCP.7
7.2.3 Additional considerations for the operations control programme .7
7.3 Materials Flow .7
7.3.1 General .7
7.3.2 Incoming materials and components .8
7.3.3 Finished goods.8
7.3.4 Waste removal .8
7.3.5 Transfer of maintenance tools and test equipment .8
7.3.6 Transfer and installation of large or stationary equipment .8
7.4 Personnel management programme . .8
7.4.1 Requirements and restrictions .8
7.4.2 Gowning programme .9
7.4.3 Training .10
7.5 Cleaning programme .11
7.5.1 General .11
7.5.2 Requirements for the cleaning programme .11
7.5.3 Special cleaning . 12
7.6 Maintenance programme . 12
8 Monitoring programme .13
Annex A (informative) Personnel management . 14
Annex B (informative) Gowning . 16
Annex C (informative) Training .18
Annex D (informative) Cleaning .20
Bibliography .24

iii
ISO 14644-5:2025(en)
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 Standardisation (CEN) Technical Committee
CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 14644-5:2004), which has been technically
revised.
The main changes are as follows:
— new normative content for development of an impact assessment, development of an Operations Control
Programme and the associated programmes that support cleanroom operation, and updated information
concerning the movement of goods and materials into and out of the cleanrooms;
— informative sections have been condensed so as not to duplicate information available in books and papers.
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.

iv
ISO 14644-5:2025(en)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to air and
surface cleanliness levels appropriate for accomplishing contamination-sensitive activities.
Consistent quality depends, in part, on cleanliness. Specified cleanliness levels for all contaminants
addressed in the ISO 14644 series can be attained and maintained through a deliberate programme to
establish and implement adequate design and operational procedures. Regulatory agencies that have
authority over processes and products produced in the cleanroom can require additional procedures and
measures.
Processes and products that benefit from the control of contamination include those in industries such as
aerospace, automotive, assorted consumer products, defence, microelectronics, optics, nuclear, scientific
research and life sciences (pharmaceuticals, biotechnology, medical devices, food, healthcare).
This document specifies basic requirements for cleanroom operations. It is intended for those who design,
construct, start up or operate a cleanroom. For guidance about consumables and equipment used in
cleanrooms refer to the ISO 14644 series.

v
International Standard ISO 14644-5:2025(en)
Cleanrooms and associated controlled environments —
Part 5:
Operations
1 Scope
This document specifies requirements for the establishment of an operations control programme (OCP) to
ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of
personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.
This document specifies operational requirements that relate to:
— providing a system that specifies policies and operational procedures for maintaining cleanliness levels;
— training of personnel;
— transferring, installing and maintaining stationary equipment;
— transferring material and portable equipment into and out of the cleanroom;
— maintaining a personnel management programme that includes a gowning programme;
— maintaining a cleaning programme that addresses special cleaning;
— maintaining a cleanroom maintenance programme;
— establishing an appropriate monitoring programme.
This document gives additional information in annexes for:
— personnel management;
— gowning;
— training;
— cleaning.
This document does not specifically address biocontamination control. For details on this topic, see
ISO 14698-1 and ISO 14698-2.
This document does not apply to the following topics:
— aspects of health and safety management that have no direct bearing on contamination control;
— specific requirements for individual industries;
— specific requirements for equipment and materials used or associated with processes and products;
— design details of equipment;
— cleaning agent compatibility with cleanroom materials.

ISO 14644-5:2025(en)
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 14644-9, Cleanrooms and associated controlled environments — Part 9: Assessment of surface cleanliness
for particle concentration
ISO 14644-10, Cleanrooms and associated controlled environments — Part 10: Assessment of surface cleanliness
for chemical contamination
ISO 14644-18, Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of
consumables
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
cleaning efficiency
fraction of specific contaminants removed from a surface by a cleaning process
Note 1 to entry: The fraction is determined by the accomplished surface cleanliness in respect to the initial surface
cleanliness.
[SOURCE: ISO 14644-13:2017, 3.3]
3.2
cleanliness
condition not exceeding a specified level of contamination
[SOURCE: ISO 14644-15:2017, 3.5]
3.3
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]

ISO 14644-5:2025(en)
3.4
clean zone
defined space which is constructed and operated in a manner to control the introduction, generation and
retention of contaminants inside the space below a maximum concentration of airborne particles based on
its designation
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(s) can be a defined space within a cleanroom or can be achieved by a separative device.
Such a device can be located inside or outside a cleanroom.
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]
3.5
consumable
item selected for a prescribed, limited use and subsequent disposal, if applicable, within cleanrooms and
controlled environments
Note 1 to entry: Consumables can be garments, gloves, (see 3.11) and wipes, swabs, paper.
Note 2 to entry: Items for use and disposal, if applicable within cleanrooms and controlled environments.
[SOURCE: ISO 14644-18: 2023, 3.9]
3.6
contamination
unwanted matter in an undesirable location
[SOURCE: ISO 14644-13:2017, 3.4]
3.7
installation
cleanroom or one or more clean zones, together with all associated structures, air-treatment systems,
services and utilities
[SOURCE: ISO 14644-1:2015, 3.1.3]
3.8
operational
agreed condition where the cleanroom or clean zone is functioning in the specified manner, with equipment
operating and with the specified number of personnel present
[SOURCE: ISO 14644-1:2015, 3.3.3]
3.9
particle
minute piece of matter with defined physical boundaries
[SOURCE: ISO 14644-1:2015, 3.2.1]
3.10
personnel
persons entering the cleanroom for any purpose

ISO 14644-5:2025(en)
3.11
personal consumable
consumable (3.5) that is worn by a person
[SOURCE: ISO 14644-18:2023, 3.15]
3.12
service life
length of time or number of cycles a consumable is suitable for use
Note 1 to entry: In this document, items are considered as consumable (3.5).
Note 2 to entry: Service life is dependent on appropriate use.
[SOURCE: ISO 14644-18:2023, 3.16, modified — added Note 1 to entry.]
3.13
shutdown
action of turning off or taking out of operation
Note 1 to entry: It can be applied to equipment within the installation.
3.14
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.
Note 3 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12]
4 Abbreviations
OCP Operations control programme
5 General
A cleanroom or associated controlled environment is designed to protect processes or products from
contamination. The operations within the cleanroom impact air cleanliness, deposition rates and surface
cleanliness. The specifications of the product and process determine the required cleanliness levels and
operational requirements.
An impact assessment is intended to identify factors that can prevent the cleanroom from attaining or
maintaining the required cleanliness concerning contaminants of interest (particles, macro-particles,
microorganisms, chemicals and/or nanoparticles). The cleanroom shall have adequate ancillary areas, such
as utilities, equipment storage and equipment preparation to support its operations. An impact assessment,
as discussed in Clause 6, is the basis for the operations control programme, which is discussed in 7.2.
A cleanroom or clean zone that operates successfully within specified limits requires a systematic approach,
starting with design and continuing throughout construction, commissioning, selecting equipment, and
operating the process. Cleaning of surfaces, equipment, and transferred items shall be accomplished in a
manner that will not impact operations. The systematic approach includes operational aspects, such as the
control and limiting of emissions and the effects of potential cross-contamination, electrostatic discharge,
maintenance and personnel.
Trained individuals are critical for cleanroom operation. Personnel executing operations in cleanrooms shall
be managed as discussed in 7.4.

ISO 14644-5:2025(en)
Operations shall be documented in procedures and monitored, as discussed in Clause 8.
An overview of cleanroom operational aspects is shown in Figure 1. The desired limits for air cleanliness,
contamination deposition rate, and product and process specifications with the intended operations control
programme are the input for the establishment of contamination control. Potentially applicable cleanroom
standards that can be used to fulfil these specifications and limits are shown in Figure 1; corresponding
paragraphs from Clauses 7 and 8 of this document are shown in parentheses.
Figure 1 — Overview of operational aspects of a cleanroom
6 Impact assessment
The goal of the impact assessment is to understand factors that may affect the cleanroom from operating
within specified limits. An impact assessment shall be performed for the start of the routine cleanroom
operation and shall be revisited or revised as part of planning major modifications, including an exchange of
stationary equipment.
The impact assessment is based on design data or as-built data for the cleanroom installation and the
specified cleanroom environment with its operations. It shall include the impact on products or processes to
aide in determining the operations in the environment.
The following aspects shall be assessed for their impact on achieving and maintaining specified
cleanliness levels:
— operations programme, including an assessment that necessary procedures are available and adequate;
— cleaning programme execution and control of surface cleanliness;
— gowning programme;
— selection of personal and non-personal consumables (ISO 14644-18, if applicable);
— maintenance programme for the installation;
— maintenance programme for the stationary equipment including considerations for repair during
operation;
— transfer of material, mobile equipment and tools in and out and within the cleanroom or clean zone;

ISO 14644-5:2025(en)
— transfer of stationary equipment in and out of the cleanroom;
— programme for monitoring of cleanliness parameters.
Special consideration shall be given for the impact of personnel. At a minimum the following aspects shall be
assessed:
— entry and exit procedures;
— maximum cleanroom occupancy;
— flow and activity of personnel within the cleanroom;
— personal attire, hygiene and behaviour (including behaviour prior to entering the cleanroom);
— use of personal electronic devices;
— health status (e.g., chronic or acute medical conditions, including shedding significantly more
contamination than anticipated);
— programmes for achieving and maintaining necessary skills;
— safety (including emergency procedures);
— policies and procedures for visitors.
The impact assessment shall address routine operation, reduced operation, shutdown and restart of the
installation.
Literature searches can provide methodologies for impact assessments that are applicable to specific
industries.
7 Operations Control
7.1 General
Successful operations in cleanrooms benefit from thorough design, construction and start up, as outlined
in ISO 14644-4, which includes considerations for products and related processes. However, cleanroom
operations that were not anticipated during design or construction phase shall also be assessed. OCP shall
be established and implemented to support maintaining the cleanroom within specified limits for operation,
reduced operation, maintenance and shutdown.
7.2 Operations control programme
7.2.1 General
The OCP is part of the overall contamination control strategy. Cleanrooms are designed to mitigate
contamination, such as particles, chemicals or microorganisms, from the product and process. Operational
elements can impact the required air and surface cleanliness levels. Adherence to the OCP will ensure
that operational requirements can be met. Subclause 7.2.3 addresses additional control requirements for
established cleanrooms that were designed with an undefined purpose or that have been modified. The OCP
includes sustainability (ISO 14644-16) and efficient use of consumables (ISO 14644-18).
The total number of personnel allowed in a cleanroom is related to the cleanroom design and the needs of
the process operations.
ISO 14644-5:2025(en)
7.2.2 Elements of the OCP
Management shall establish, implement and maintain an OCP. It shall address how the cleanroom shall be
operated within specified limits while manufacturing or handling products. The OCP shall address start-up,
reduced operation, and shutdown.
At a minimum, the OCP shall address and include the following:
a) documented impact assessment;
b) standard operating procedures or work instructions for all aspects of cleanroom setup, operation,
reduced operation, and shutdown;
c) documents showing the flow of products and raw materials, equipment, personnel and waste;
d) personnel management programme (requirements, gowning, training);
e) cleaning programme;
f) maintenance programme (cleanroom installation, equipment);
g) monitoring programme.
7.2.3 Additional considerations for the operations control programme
The following points can have an impact on the cleanroom operation and shall be assessed for any changes
to the design:
a) utilities (compressed gasses, water systems, chemicals);
b) vibration;
c) electromagnetic fields (e.g., interference, compatibility);
d) electrostatic properties of materials;
e) lighting (e.g., natural, artificial, and non-visible wavelength);
f) chemical emissions;
g) thermal load from equipment;
h) changed airflow patterns due to equipment placement;
i) modified standard operating procedures, work instructions and calibrations;
j) storage of materials.
7.3 Materials Flow
7.3.1 General
A documented system to control the transfer of materials, components, equipment and tools into and out of
the cleanroom shall be established.
Only materials, equipment and cleaning agents that are evaluated and found acceptable for use in the
cleanroom shall be permitted in the cleanroom. A formal written procedure shall be in place for handling
the response to an unexpected entry of unapproved items in the cleanroom.
Documented information shall be retained for the evaluation and acceptability of all materials used in the
cleanroom.
ISO 14644-5:2025(en)
7.3.2 Incoming materials and components
Protective packaging for transport or storage should be removed outside the cleanroom and the airlock
and the materials cleaned to an agreed particulate level compatible with the room’s ISO specification.
Cleanroom packaging, which is in contact with or intended to protect the materials and which is specifically
approved for entry into the cleanroom, may be removed inside the cleanroom before use. ISO 14644-9 and
ISO 14644-10 define acceptable cleanliness levels for particles and chemicals, as applicable.
NOTE Cardboard is not regarded as suitable material for cleanrooms, unless specially proven (ISO 14644-18).
Additional cleaning of incoming materials can occur in a controlled environment, airlocks, and pass-throughs
to meet increasing cleanliness. Cleaning shall be performed and can include outer bag removal, wiping, UV
light, or gases, as appropriate and can involve a system of suitable clean containers, such as a cleanroom-
approved conveyor or cart. Carts and containers and the materials transported in them should be assessed
for suitability as stated in ISO 14644-13, ISO 14644-14, and ISO 14644-15, as applicable.
7.3.3 Finished goods
Finished product should be protected, e.g., inside an approved container or packaging system, prior to
leaving the cleanroom through a designated and controlled exit. Any cart or containers shall be cleaned
appropriately before return to the cleanroom.
7.3.4 Waste removal
Solid material waste should be placed in specific containers for safe removal. Wipes and used consumables
may be separated and may be identified for recycling. Liquid waste should be marked and sealed for
controlled disposal outside the room. Gaseous waste and exhaust air should be properly disposed of outside
of the cleanroom. Consider whether local requirements or contamination control measures require the use
of a dedicated exit airlock for wastes.
7.3.5 Transfer of maintenance tools and test equipment
Maintenance tools and test equipment should be thoroughly cleaned and packaged, if applicable, before
admission to the cleanroom through an airlock.
It is recommended that frequently used tools and equipment, such as ladders, tool boxes and cleanroom
cleaning equipment, remain in the cleanroom.
7.3.6 Transfer and installation of large or stationary equipment
Where process equipment cannot be installed or removed without interruption to the cleanroom, a
documented process that includes a description and approval of the work shall be followed.
7.4 Personnel management programme
7.4.1 Requirements and restrictions
Personnel are a major source of contamination to products and the cleanroom environment. Potential
contamination due to activities and presence of personnel, particularly with respect to specified personnel
flow, hand washing and personal hygiene, are part of the personnel management programme.
Physical or timely separation between ingoing and outgoing cleanroom personnel is recommended to reduce
the impact of cross-contamination on the cleanroom, product or process. Consider whether one-way flow of
personnel is required in the cleanroom.
All cleanroom personnel shall comply with requirements for cleanroom entry, operational procedures, and
basic behaviours and conduct requirements that include:
— donning all required cleanroom garments properly prior to cleanroom entry according to the cleanroom
garment programme (7.4.2);
ISO 14644-5:2025(en)
— wearing their cleanroom garments and other appropriate items according to procedures and exit the
cleanroom if the integrity of the garments is damaged or otherwise compromised;
— adhering to all specified personal hygiene requirements;
— not entering the cleanroom if displaying visible illness, or experiencing symptoms that are not under
control (e.g., excessive sneezing or coughing);
— entering and exiting the cleanroom only through designated personnel airlocks, if applicable;
— completing all training and participate in continual education or training courses on a schedule;
— adhering to all applicable procedures, e.g., entry and exit, transfer, gowning, operation control and
production processes;
— reporting cleanroom problems, including potential contamination issues, to management promptly.
As part of the impact assessment (Clause 6), a review shall be conducted to determine requirements for
personal items and personal hygiene that can be sources of particle, microbial, or chemical contamination.
Examples of items to consider for exclusion from the cleanroom can be found in Annex A, Personnel
Management.
Practices that keep the impact of behaviour on cleanroom cleanliness under control shall be specified. At a
minimum, the criticality assessed in the impact assessment should guide how the following activities are
conducted:
— use of airlocks and personnel transfer;
— behaviour for planned or unplanned shutdowns/evacuations;
— use of doors;
— organization and management of workstations according to specified requirements;
— conduct in a manner that minimizes the possibility of contamination being generated, stirred up, or
transferred or deposited on or into product;
— cleaning practices.
7.4.2 Gowning programme
7.4.2.1 General
As part of cleanroom operation, a gowning procedure shall be established and implemented before personnel
are allowed to enter the cleanroom. The purpose of the gowning programme is to ensure that cleanliness
levels with respect to particles, chemicals and microorganisms can be maintained when personnel are
in the cleanroom. Personal consumables, e.g., garments, gloves, face masks, shall be selected and used
appropriately in accordance with ISO 14644-18 and the user specification.
The gowning programme shall be considered in the impact assessment.
7.4.2.2 Requirements for a gowning programme
Facilities and procedures shall be in place for proper handling of cleanroom personal consumables.
At a minimum the following items shall be addressed in the gowning programme:
a) fabric selection to meet the barrier, strength, and lint properties as required to maintain the desired
cleanliness level for the specified activity, including repair and laundry requirements;
b) personal consumables selection process and its result and conclusion, including documentation;
c) gowning procedures;
ISO 14644-5:2025(en)
NOTE Gowning procedures can be adapted for various activities performed in the cleanroom, e.g., for
personnel who are present for operations, maintenance, or supervision.
d) justification for multiple uses of personal consumable, including documentation;
e) justification of and documentation for service life of garments;
f) storage of the personal consumables;
g) removal of used personal consumables;
h) sterility, if required.
Additional information and details are provided in Annex B.
7.4.3 Training
Management shall establish and implement a programme to train persons who enter a cleanroom. Training
requirements shall be based on the role and area which the person will access.
The ability of personnel to incorporate all elements of cleanroom training into practice is essential to the
continuous effective operation of the cleanroom.
Appropriate training shall be completed prior to cleanroom entry. A training programme should consider
the following topics:
a) cleanroom operation procedures;
b) personal hygiene procedures;
c) entry and exit of personnel;
d) gowning requirements and procedures;
e) necessary procedures, and work instructions, including cleanroom procedures to maintain
cleanliness levels;
f) transfer of materials and equipment; this can include items that are approved for use in cleanrooms, and
those not approved for use;
g) cleaning procedures, where applicable;
h) behaviour in cleanrooms to minimize generation of contamination that can be transferred or deposited
on or into the product;
i) monitoring levels, such as alert and alarm levels and required responses;
j) individual behaviour and responsibilities for cleanroom access and operations;
k) procedures for problem reporting, and encouraging cleanroom personnel to report potential issues;
l) requirements for individual personnel certification for cleanroom access, and how often recertification
is required;
m) personnel monitoring programme;
n) safety and emergency response.
Management should periodically assess whether training is adequate and shall ensure, that personnel have
completed the required training. Periodic retraining is recommended and should be scheduled, as necessary.
Basic training documentation should include course contents, personnel identification information, training
and learning objective check dates. Documented evidence for successful completion of training programme
shall be available. A system can be used to document completion of required training.

ISO 14644-5:2025(en)
Additional information and details on training can be found in Annex C.
7.5 Cleaning programme
7.5.1 General
Cleanroom cleaning can be divided into room surfaces, critical surfaces and equipment cleaning. The
required cleanliness level of surfaces and the means to achieve them shall be specified.
An assessment shall be executed to determine the required cleanliness levels for all cleanroom surfaces
(e.g., cleanroom installation, equipment, tools). This assessment shall be used as the basis for the cleaning
programme.
The cleaning programme shall include the following topics:
a) contaminants of concern, such as particles, chemicals, microorganisms, as applicable based on product
or process requirements;
b) required cleanliness levels;
c) areas or items to be cleaned;
d) initial contamination level;
e) cleaning appropriateness, efficiency and potential residues;
f) cleaning frequency;
g) cleaning methodology;
h) disinfection methodology, if applicable;
i) required procedures and documentation.
The cleaning frequency should be established to maintain the required surface cleanliness levels. The
time between cleaning cycles will be based on the cleaning efficiency and contributors to the surface
contamination rate, e.g., the number of personnel, their garments, and their work methods, and process
emissions.
In case of control of microorganisms, a disinfection prog
...