prEN ISO 14644-4

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO/DIS 14644:2021)

Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-Inbetriebnahme (ISO/DIS 14644 4:2021)

Salles propres et environnements maîtrisés apparentés - Partie 4 : Conception, construction et mise en fonctionnement (ISO/DIS 14644:2021)

Čiste sobe in podobna nadzorovana okolja - 4. del: Konstruiranje, izdelava in zagon (ISO/DIS 14644-4:2021)

General Information

• Status: Not Published
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 21-Jun-2022
• Completion Date: 21-Jun-2022
• Ref Project: oSIST prEN ISO 14644-4:2021 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO/DIS 14644-4:2021)

RELATIONS

• Revised: EN ISO 14644-4:2001 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
• Effective Date: 14-Nov-2018

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14644-4:2021
01-december-2021
Čiste sobe in podobna nadzorovana okolja - 4. del: Konstruiranje, izdelava in
zagon (ISO/DIS 14644-4:2021)

Cleanrooms and associated controlled environments - Part 4: Design, construction and

start-up (ISO/DIS 14644-4:2021)

Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-

Inbetriebnahme (ISO/DIS 14644 4:2021)
Salles propres et environnements maîtrisés apparentés - Partie 4 : Conception,
construction et mise en fonctionnement (ISO/DIS 14644-4:2021)
Ta slovenski standard je istoveten z: prEN ISO 14644
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-4:2021 en,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14644-4:2021
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oSIST prEN ISO 14644-4:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-4
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-10-11 2022-01-03
Cleanrooms and associated controlled environments —
Part 4:
Design, construction and start-up
Salles propres et environnements maîtrisés apparentés —
Partie 4: Conception, construction et mise en fonctionnement
ICS: 13.040.35
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-4:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

3.1 General ........................................................................................................................................................................................................... 2

3.2 Installation .................................................................................................................................................................................................. 5

4 Abbreviations........................................................................................................................................................................................................... 6

5 General ............................................................................................................................................................................................................................ 6

6 Requirements .......................................................................................................................................................................................................... 9

6.1 Cleanroom requirements ............................................................................................................................................................... 9

6.2 Other requirements .........................................................................................................................................................................10

6.3 Documentation ....................................................................................................................................................................................10

7 Design ...........................................................................................................................................................................................................................10

7.1 General ........................................................................................................................................................................................................10

7.2 Conceptual Design.............................................................................................................................................................................11

7.3 Basic Design ............................................................................................................................................................................................11

7.4 Detailed Design ....................................................................................................................................................................................12

7.5 Change management ......................................................................................................................................................................12

8 Construction ...........................................................................................................................................................................................................13

8.1 General ........................................................................................................................................................................................................13

8.2 Construction plan ..............................................................................................................................................................................13

8.2.1 General...................................................................................................................................................................................13

8.2.2 Schedule ...............................................................................................................................................................................13

8.2.3 Quality Plan .......................................................................................................................................................................13

8.2.4 Clean Build Protocol ..................................................................................................................................................13

8.3 Construction verification ............................................................................................................................................................14

8.4 Documentation ....................................................................................................................................................................................14

9 Start-up ........................................................................................................................................................................................................................14

9.1 General ........................................................................................................................................................................................................14

9.2 Commissioning ....................................................................................................................................................................................15

9.2.1 General...................................................................................................................................................................................15

9.2.2 Setting to Work ...............................................................................................................................................................15

9.2.3 Operational and performance verifications ..........................................................................................15

9.3 Training ......................................................................................................................................................................................................15

9.4 Handover ...................................................................................................................................................................................................15

9.5 Documentation ....................................................................................................................................................................................15

9.5.1 Commissioning documentation .......................................................................................................................15

9.5.2 Performance monitoring instructions........................................................................................................15

9.5.3 Maintenance instructions .....................................................................................................................................16

9.5.4 Maintenance record ...................................................................................................................................................16

9.5.5 Record of training ........................................................................................................................................................16

Annex A (informative) Guidance on requirements .............................................................................................................................17

Annex B (informative) Guidance on design ................................................................................................................................................26

Annex C (informative) Guidance on construction ................................................................................................................................47

Annex D (informative) Guidance on start-up ............................................................................................................................................54

Bibliography .............................................................................................................................................................................................................................59

© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(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 documents 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).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

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.

This second edition cancels and replaces the first edition (ISO 14644-4:2001), which has been

technically revised.
The main changes compared to the previous edition are as follows:
— Normative part is extended
— The process of gathering and defining requirements is included

— Scope is extended from classified cleanrooms to additional cleanliness attributes

— The text of the whole document has been revised or clarified to aid in application

A list of all parts in the ISO 14644 series and the ISO 14698 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 2021 – All rights reserved
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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)
Introduction

Cleanrooms and associated controlled environments provide for the control of airborne particulate

contamination and, if relevant, other forms of contamination, to levels appropriate for accomplishing

contamination-sensitive activities. Products and processes that benefit from the control of airborne

contamination include those in such industries as aerospace, microelectronics, pharmaceuticals,

medical devices, food and research and development laboratories and some applications in healthcare.

Cleanrooms and associated controlled environments are classified for air cleanliness by particle

concentration (ISO 14644-1). Cleanliness attributes relating to chemicals, nano-scale particles and

viable particles (microorganisms) as well as cleanliness of surfaces can also be considered.

This part of ISO 14644 is one of the series of International Standards concerned with cleanrooms and

associated controlled environments prepared by ISO/TC 209.

This part, Part 4, provides guidance for the design, construction and start-up of cleanrooms, both

new and those undergoing modification or refurbishment. In this edition of Part 4, a more structured

approach is provided with separate normative sections on requirements, design, construction and

start-up, supported by four corresponding informative annexes.
For this edition, key recommendations and considerations include:

a) A structured approach with a logical sequential flow through the design, construction and start

up stages. There will normally be reviews and iterations of the requirements, contamination

control concepts, layouts and other considerations. The final design should be reviewed against the

requirements before construction commences and when construction is complete. The operation

and performance is verified against the requirements during start-up.

b) Inclusion of other cleanliness attributes. The ISO 14644 series has parts that deal with other

cleanliness attributes, namely chemicals, nano-scale particles, macro-particles and, in ISO 14698,

viable particles (microorganisms) as well as cleanliness of surfaces. These other attributes should

be considered if relevant, bearing in mind that the primary requirement for a cleanroom or clean

zone is that it meets a classification by airborne particle concentration according to ISO 14644-1.

c) Importance of a contamination risk assessment. Assessments should be carried out to better

understand the contamination risk and its impact on the process and product and to identify the

critical control points in the cleanroom or clean zone

d) A clear statement of requirements in terms of what users want to do and achieve along with

acceptance criteria for performance parameters. This is critical and should be captured prior to the

start of the design process.

e) Ventilation effectiveness. This revision focusses on the importance of ventilation effectiveness

through control of air flow patterns and clean up recovery rates. Two measures are identified: air

change effectiveness and contaminant removal effectiveness.

f) Using air supply rate for calculations of contaminant removal. This will make it possible to achieve

energy-efficient cleanrooms whilst achieving the required level of contamination.

g) Energy efficiency and lifecycle considerations. Energy efficiency in cleanrooms is very important

and is covered by ISO 14644 part 16.

h) A clean build protocol. This is included to minimise contamination during construction of the

cleanroom.

An ISO standard is not a textbook. Therefore only directly relevant information to “Cleanrooms and

associated controlled environments” is included in the informative annexes. Supporting information is

given in the Bibliography.
© ISO 2021 – All rights reserved v
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oSIST prEN ISO 14644-4:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-4:2021(E)
Cleanrooms and associated controlled environments —
Part 4:
Design, construction and start-up
1 Scope

This part of ISO 14644 specifies the process for creating a cleanroom from requirements through

to its design, construction and start-up. It applies to new and refurbished or modified cleanroom

installations. It does not prescribe specific technological or contractual means of achieving these

requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and

performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne

particle concentration. Detailed checklists are provided for the various stages including requirements,

design, construction and start-up, which include important performance parameters to be considered.

Energy management design approaches are identified, to support an energy efficient cleanroom

design. Construction guidance is provided including requirements for start-up and verification. A basic

element of this standard is consideration of aspects including maintenance that will ensure continued

satisfactory operation for the entire lifecycle of the cleanroom.

NOTE Further guidance in respect of the above requirements is given in annexes A to D. Normative

parts 1, 2, 8, 9, 10, 12 and 17 of ISO 14644 provide complementary information. ISO 14644-7 offers guidance on

design, construction and requirements for Separative Devices (clean air hoods, glove boxes, isolators and mini-

environments).
The following subjects are mentioned but not addressed in this standard:

— Specific operational activities, processes to be accommodated and process equipment in the

cleanroom installation

— Fire and safety regulations. The appropriate national and local regulations shall be respected and

addressed during the design as appropriate.

— On-going operation, cleaning and maintenance activities, which are covered by ISO14644-5

2 Normative references

The following normative documents contain provisions which, through reference in this text, constitute

provisions of this part of ISO 14644. For dated references, subsequent amendments to, or revisions of,

any of these publications do not apply. However, parties to agreements based on this part of ISO 14644

are encouraged to investigate the possibility of applying the most recent editions of the normative

documents indicated below. For undated references, the latest edition of the normative document

referred to applies. Members of ISO and IEC maintain registers of currently valid International

Standards.

ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness

by particle concentration

ISO 14644-2, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence

of cleanroom performance related to air cleanliness by particle concentration

ISO 14644-3, Cleanrooms and associated controlled environments — Part 3: Test methods

ISO 14644-16, Cleanrooms and associated controlled environments — Part 16: Energy efficiency in

cleanrooms and separative devices
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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)

In case where there are air cleanliness requirements with respect to chemicals, nano scale particles

or viable particles (microorganisms), or where there are particle deposition rate requirements, the

associated document should be used as a normative reference:

ISO 14644-8, Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness

by chemical concentration (ACC)

ISO 14644-12, Cleanrooms and associated controlled environments — Part 12: Specifications for

monitoring air cleanliness by nanoscale particle concentration

ISO 14698-1, Cleanrooms and associated controlled environments — Biocontamination control — Part 1:

General principles and methods

ISO 14698-2, Cleanrooms and associated controlled environments — Biocontamination control — Part 2:

Evaluation and interpretation of biocontamination data

In cases where there are surface cleanliness requirements with respect to particles or chemicals the

following additional standards should be used as a normative reference:

ISO 14644-9, Cleanrooms and associated controlled environments — Part 9: Classification of surface

cleanliness by particle concentration

ISO 14644-10, Cleanrooms and associated controlled environments — Part 10: Classification of surface

cleanliness by chemical concentration

ISO 14644-17, Cleanrooms and associated controlled environments — Part 17: Particle deposition rate

applications
3 Terms and definitions

For the purposes of this part of ISO 14644 the following terms and definitions apply:

ISO and IEC maintain terminological 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 General
3.1.1
Air change effectiveness
ACE

ratio between the recovery rate at a location or locations in a cleanroom (3.1.4) and the overall recovery

rate of the cleanroom after a contamination event
[1]

Note 1 to entry: The recovery rate is defined and measured in accordance with ISO 14644-3 .

[SOURCE: ISO 14644-16:2019. 3.2.7]
3.1.2
classification

method of assessing level of cleanliness against a specification for a cleanroom or clean zone

Note 1 to entry: Levels should be expressed in terms of an ISO Class, which represents maximum allowable

concentrations of particles in a unit volume of air.
[SOURCE: ISO 14644-1:2015, 3.1.4]
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ISO/DIS 14644-4:2021(E)
3.1.3
cleanliness
condition not exceeding a specified level of contamination
[SOURCE: 14644-15:2017, 3.5]
3.1.4
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 might also be

specified and controlled.

Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,

humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.1.5
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 might also be

specified and controlled.

Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might 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 might also be controlled as required, e.g. temperature,

humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.1.6
commissioning

planned and documented series of inspections, adjustments, measurements, tests and verifications

carried out systematically to set the installation into correct technical operation as specified

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of testing

other forms of determination such as performing alternative calculations or reviewing documents

3.1.7
contaminant

any particle, chemical or microorganism that adversely affects the product or process

3.1.8
contaminant removal effectiveness
CRE

ratio of particle concentration in the air leaving the cleanroom to the average of particle concentration

in the working plane of the cleanroom, when particles entering from filtered supply air are ignored

Note 1 to entry: If the air leaves the cleanroom at more than one point then the weighted average of the particle

concentrations based on the relative flowrates can be used
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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)

Note 2 to entry: The number and positioning of the sampling locations for determining the average particle

concentration in the working plane of the cleanroom can be based on the method given in 14644-1:2015

Note 3 to entry: The local particle concentration is dependent on the airflow pattern in the cleanroom and may

vary significantly in the cleanroom. CRE in a sub-area of interest in the cleanroom may be calculated by selecting

a single sampling location considered to be representative of the characteristics of the sub-area of interest

Note 4 to entry: Particles may be replaced by another airborne contaminant

[SOURCE: ISO 14644-16:2019, 3.2.5, modified — definition revised and Notes 1 to 3 to entry added].

3.1.9
customer

person or organisation that could or does receive a product or a service that is intended for or required

by this person or organisation

EXAMPLE Consumer, client, end-user, retailer, receiver of product or service from an internal process

beneficiary and purchaser.
Note 1 to entry: A customer can be internal or external to the organisation.
[SOURCE: ISO 9001-2015, 3.2.4]
3.1.10
non-unidirectional airflow

air distribution where the supply air entering the cleanroom or clean zone mixes with the internal air

by means of induction
[SOURCE: ISO 14644-1:2015, 3.2.8]
3.1.11
particle
minute piece of matter with defined physical boundaries
[SOURCE: ISO 14644-1:2015, 3.2.1]
3.1.12
setting to work
activities to bring a system from a static state into correct operation
3.1.13
source strength
number of airborne particles or other airborne contaminants considered
...