ISO 14644-4:2022

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

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and 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 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 document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom. NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 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 document: - specific operational activities, processes to be accommodated and process equipment in the cleanroom installation; - fire and safety regulations; - ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

Salles propres et environnements maîtrisés apparentés — Partie 4: Conception, construction et mise en service

Le présent document spécifie le processus de création d’une salle propre allant des exigences jusqu’à la conception, la construction et la mise en service. Il s’applique aux installations de salles propres nouvelles, rénovées ou modifiées. Il ne prescrit pas de moyens technologiques ou contractuels spécifiques pour satisfaire à ces exigences. Il est destiné aux utilisateurs, prescripteurs, concepteurs, acheteurs, fournisseurs, constructeurs et vérificateurs des performances d’installations de salles propres. La principale considération en matière de propreté est la concentration particulaire de l’air. Des listes de contrôle détaillées sont fournies pour les différentes étapes: les exigences, la conception, la construction et la mise en service. Celles-ci comprennent les paramètres de performance importants à prendre en compte. Des approches de conception basées sur le management de l’énergie sont identifiées afin de permettre une conception de salle propre efficace sur le plan énergétique. Des recommandations en matière de construction sont fournies, incluant des exigences pour la mise en service et la vérification. L’un des principaux éléments du présent document concerne les aspects à prendre en considération, maintenance comprise, qui sont destinés à garantir un fonctionnement constant satisfaisant pendant tout le cycle de vie de la salle propre. NOTE D’autres recommandations sont données dans les Annexes A à D. L’ISO 14644-1, l’ISO 14644-2, l’ISO 14644-8, l’ISO 14644-9, l’ISO 14644-10, l’ISO 14644-12 et l’ISO 14644-17 fournissent des informations complémentaires. L’ISO 14644-7 propose des recommandations relatives à la conception, à la construction et aux exigences spécifiques des dispositifs séparatifs (postes à air propre, boîtes à gants, isolateurs et mini‑environnements). Les sujets suivants sont mentionnés, mais non traités dans le présent document: — des activités opérationnelles spécifiques, des procédés spécifiques et équipements de procédé à héberger dans l’installation de salle propre; — réglementations de sécurité et de protection incendie; — activités courantes d’exploitation, de nettoyage et de maintenance, traitées dans l’ISO14644-5.

General Information

• Status: Published
• Publication Date: 27-Nov-2022
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: ISO/TC 209 - Cleanrooms and associated controlled environments
• Drafting Committee: ISO/TC 209/WG 4 - Design and construction
• Current Stage: 6060 - International Standard published
• Start Date: 28-Nov-2022
• Due Date: 26-Oct-2022
• Completion Date: 28-Nov-2022

Relations

• Consolidates: ISO 14404-3:2017 - Calculation method of carbon dioxide emission intensity from iron and steel production - Part 3: Steel plant with electric arc furnace (EAF) and coal-based or gas-based direct reduction iron (DRI) facility
• Effective Date: 06-Jun-2022
• Revises: ISO 14644-4:2001 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
• Effective Date: 10-Dec-2016

Overview

ISO 14644-4:2022 - "Cleanrooms and associated controlled environments - Part 4: Design, construction and start‑up" defines a structured process for creating or modifying cleanrooms from requirements capture through design, construction and start‑up (commissioning). Applicable to new, refurbished and modified installations, the standard focuses primarily on controlling airborne particle concentration and provides checklists, verification steps and lifecycle considerations to ensure sustained performance. It does not mandate specific technologies or contractual approaches.

Key topics and technical requirements

• Requirements capture and documentation
  • Clear statement of purpose, acceptance criteria and performance parameters prior to design.
• Design process
  • Conceptual, basic and detailed design stages with design review against requirements.
  • Consideration of additional cleanliness attributes (chemicals, nanoscale particles, viable particles) when relevant.
• Ventilation and contamination control
  • Emphasis on ventilation effectiveness and airflow patterns. Two effectiveness measures identified: Air Change Effectiveness (ACE) and Contaminant Removal Effectiveness (CRE).
  • Use of air supply rates for contaminant dilution/removal calculations to support energy‑efficient layouts.
• Energy management and lifecycle
  • Energy‑efficient cleanroom design approaches and life‑cycle considerations (complements ISO 14644‑16).
• Construction and clean build protocol
  • Construction planning, quality plans and a clean build protocol to limit contamination during building.
  • Construction verification and documentation requirements.
• Start‑up / Commissioning
  • Setting to work, functional and performance verifications, training, handover and maintenance instructions.
  • Records: commissioning documentation, maintenance records and training logs.
• Risk assessment and change management
  • Contamination risk assessments to identify critical control points and change management throughout design and construction.

Practical applications and who uses it

ISO 14644‑4 is used by:

• Cleanroom specifiers, designers and architects for compliant layouts and HVAC/airflow strategies.
• Purchasers, suppliers and contractors to define deliverables, quality plans and clean build protocols.
• Builders and commissioning teams to structure construction verification and start‑up testing.
• Performance verifiers and facility managers for acceptance testing, handover and lifecycle maintenance planning.

Typical industries: pharmaceuticals, medical devices, microelectronics, aerospace, food processing, research laboratories and healthcare environments requiring controlled airborne particulates.

Related standards

• ISO 14644‑1 (air cleanliness classification), ISO 14644‑2 (testing/monitoring), ISO 14644‑5 (operation, cleaning, maintenance), ISO 14644‑7 (separative devices), ISO 14644‑16 (energy efficiency), plus other parts of the ISO 14644 series for complementary guidance.
  Note: ISO 14644‑4 does not address fire/safety regulations or specific operational processes - refer to relevant codes and the other ISO 14644 parts.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 14644-4
Second edition
2022-11
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 service
Reference number
© ISO 2022
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 S c op e . 1
2 Nor m at i ve r ef er enc e s . 1
3 Terms and definitions . 1
3.1 G eneral . 2
3 . 2 I n s t a l l at ion . 5
4 Abbr ev i at ed t er m s . 5
5 G ener a l . 6
6 R e qu i r ement s . 7
6.1 C leanroom requirements . 7
6.2 O ther requirements . 9
6 . 3 D o c u ment at ion . 9
7 D e sig n . 9
7.1 G eneral . 9
7. 2 C onc ep t u a l de s i g n . . . 10
7. 3 Ba s ic de s i g n . 10
7.4 D e t a i le d de s i g n . 11
7. 5 C ha n g e ma nag ement . 11
8 C on s t r uc t ion .12
8.1 General .12
8 . 2 C on s t r uc t ion pl a n .12
8.2.1 General .12
8 . 2. 2 S c he du le . 12
8.2.3 Quality plan .12
8.2.4 C lean build protocol .12
8.3 Construction verification .13
8 .4 D o c u ment at ion . 13
9 S t a r t-up .13
9.1 G eneral .13
9. 2 C om m i s s ion i n g . 14
9.2.1 G eneral . 14
9.2.2 S etting to work . 14
9.2.3 Functional and performance verifications . 14
9. 3 Tr a in in g . 14
9.4 Ha ndover . 14
9. 5 D o c u ment at ion . 14
9. 5 .1 C om m i s s ion i n g do c u ment at ion . 14
9. 5 . 2 Per f or m a nc e -mon it or i n g i n s t r uc t ion s . 15
9. 5 . 3 M a i nt en a nc e i n s t r uc t ion s . 15
9. 5 .4 M a i nt en a nce r e cor d . 15
9.5.5 R ecord of training .15
Annex A (informative) Guidance on requirements .16
Annex B (informative) Guidance on design .24
Annex C (informative) Guidance on construction .45
Annex D (informative) Guidance on start-up .51
Bibliography .56
iii
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, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 14644-4:2001), which has been
technically revised.
The main changes are as follows:
— normative content has been extended;
— the process of gathering and defining requirements has been added;
— the scope has been extended from classified cleanrooms to include additional cleanliness attributes;
— the entire text has been revised or clarified to aid its application.
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
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, nanoscale particles and
viable particles (microorganisms), as well as cleanliness of surfaces, can also be considered.
This document is one of the series of International Standards concerned with cleanrooms and associated
controlled environments prepared by ISO/TC 209.
This document provides guidance for the design, construction and start-up of cleanrooms, both new
and those undergoing modification or refurbishment. In this edition, 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 are 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, nanoscale 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 (locations) in the cleanroom or clean zone.
d) A clear statement of requirements, namely everything needed for input into the design, including
the purpose of the cleanroom and the acceptance criteria for performance parameters. This is
critical and should be documented prior to the start of the design process.
e) Ventilation effectiveness. This revision focuses on the importance of ventilation effectiveness
through control of air-flow patterns and clean-up recovery rates. Two measures are identified: air
change effectiveness (ACE) and contaminant removal effectiveness (CRE).
f) Using air supply rate for calculations of contaminant dilution and removal. This will make it possible
to achieve energy-efficient cleanrooms while achieving the required level of air cleanliness.
g) Energy efficiency and life cycle considerations. Energy efficiency in cleanrooms is very important
and is covered by ISO 14644-16.
h) A clean build protocol. This is included to minimize contamination during construction of the
cleanroom.
Information directly relevant to cleanrooms and associated controlled environments is included in the
informative annexes. Supporting information is given in the Bibliography.
v
INTERNATIONAL STANDARD ISO 14644-4:2022(E)
Cleanrooms and associated controlled environments —
Part 4:
Design, construction and start-up
1 S cope
This document specifies the process for creating a cleanroom from requirements through to its design,
construction and start-up. It applies to new, refurbished and 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 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 document is consideration
of aspects, including maintenance, that will help to ensure continued satisfactory operation for the
entire life cycle of the cleanroom.
NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9,
ISO 14644-10, ISO 14644-12 and ISO 14644-17 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 document:
— specific operational activities, processes to be accommodated and process equipment in the
cleanroom installation;
— fire and safety regulations;
— ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.
2 Normat ive 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 14644-16, Cleanrooms and associated controlled environments — Part 16: Energy efficiency in
cleanrooms and separative devices
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 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
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]
3.1.3
cleanliness
condition not exceeding a specified level of contamination
[SOURCE: ISO 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: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
Note 4 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.
[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
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.
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.
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 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 organization.
[SOURCE: ISO 9000:2015, 3.2.4]
3.1.10
non-unidirectional airflow
non-UDAF
air distribution where the supply air entering the cleanroom or clean zone mixes with the internal air
[SOURCE: ISO 14644-1:2015, 3.2.8 modified — Definition revised.]
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 emitted per time unit
expressed as a rate
Note 1 to entry: A source can be a person, equipment or an object.
Note 2 to entry: Each rate should be indicated with a specific particle size. Particles are often emitted in multiple
sizes and each size may have a different rate.
3.1.14
start-up
period following the construction of an installation when the systems and installation are brought into
active service, including all commissioning activities, training and handover to the customer
3.1.15
supplier
organisation that provides a product or a service
EXAMPLE Producer, distributor, retailer or vendor of a product or service.
Note 1 to entry: A supplier can be internal or external to the organization.
Note 2 to entry: In a contractual situation, a supplier is sometimes called a “contractor”.
[SOURCE: ISO 9000:2015, 3.2.5]
3.1.16
unidirectional airflow
UDAF
controlled airflow through the entire cross-section of a cleanroom or a clean zone with a steady velocity
and airstreams that are considered to be parallel
Note 1 to entry: This type of airflow results in a directed transport of particles and other contaminants from the
clean zone.
[SOURCE: ISO 14644-1:2015, 3.2.7, modified — Note 1 to entry added.]
3.1.17
ventilation effectiveness
dimensionless index that relates to both the dilution and removal of indoor airborne contaminants as
it determines how effectively the filtered supply air is distributed to the critical areas in the occupied
space and the contamination removed by the air leaving the room
Note 1 to entry: Ventilation effectiveness can be expressed in terms of air change effectiveness (ACE) or
contaminant removal effectiveness (CRE). In cleanrooms, mostly ACE is used.
3.1.18
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection, testing or
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]
3.2 Installation
3.2.1
air-handling unit
AHU
unit or plant comprising fan, filtration, heating, cooling, humidification or dehumidification and mixing
of fresh air and recirculated air, that provides conditioned air to a room or facility
3.2.2
air diffuser
device placed at the outlet of a room air supply terminal to improve distribution and mixing of supply
air with room air
Note 1 to entry: A mesh grille or a perforated screen is not considered to be a diffuser.
3.2.3
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]
3.2.4
filter system
assembly composed of filter, frame and other support mechanism or other housing
[SOURCE: ISO 14644-3:2019, 3.3.4]
3.2.5
final filter
last high-efficiency air filter in the system before the air enters the cleanroom or clean zone
Note 1 to entry: Terminal filter is a final filter located at the point where the air enters the cleanroom
[SOURCE: ISO 14644-3:2019, 3.3.5, modified — Definition revised and Note 1 to entry added.]
3.2.6
turn-down
controlled reduction of airflow velocity in unidirectional airflow cleanrooms and clean air devices or
airflow rates in non-UDAF cleanrooms in order to save energy during periods when the cleanroom is
not in operation
[SOURCE: ISO 14644-16:2019, 3.2.8]
4 Abbreviated terms
ACE air change effectiveness
AHU air-handling unit
CRE contaminant removal effectiveness
ESD electrostatic discharge
HEPA high-efficiency particulate air (filter)
HVAC heating, ventilation and air conditioning
MCP microbe-carrying particle
non-UDAF non-unidirectional airflow
UDAF unidirectional airflow
ULPA ultra-low penetration air (filter)
URS user requirement specification
5 General
A cleanroom or clean zone can be used to protect products and processes that are sensitive to airborne
particles and other types of contaminants. A cleanroom installation can be new or the expansion or
modification of an existing installation.
The life cycle of the cleanroom shall be considered from the outset. This includes its design, construction,
start-up, occupation, operation, renovation, expansion, repair and demolition and consequent recycling
or disposal.
An analysis of the need for a cleanroom and its justification shall be performed. This analysis shall
address, but is not limited to:
a) contamination risk to product, processes, people and environment (6.1);
b) statutory requirements;
c) relevant regulations;
d) business-related aspects (financial viability and resource capability);
e) future needs.
The flowchart in Figure 1 is intended to guide the user through this document with a logical sequence of
the work. The annexes are aligned with the clauses in the main text (requirements, design, construction
and start-up).
There shall be a review after each step based on the requirements and previous steps. In a small project
these steps may be simplified.
This document can also be used for non-classified clean controlled environment and controlled zones.
Figure 1 — Flowchart: from requirements to design, construction and start-up
6 Requirements
6.1 Cleanroom requirements
Cleanroom features and contamination control requirements are established as necessary to reliably
and repeatably create environments of desired quality to protect patients, products, processes,
personnel or the environment. An assessment can be carried out in order to identify potential risks of
the facility to be designed.
The following items shall be considered and defined as appropriate by the customer and designer:
a) the intended use of the installation and the operations to be carried out therein;
b) regulatory requirements;
c) the relevant parts of ISO 14644 that will be used, including number, edition and year of publication;
d) the air cleanliness class at the designated particle size(s) and the defined occupancy states in
accordance with ISO 14644-1;
e) any other requirements with respect to particles or other contaminants in air or on surfaces (e.g.
particle number concentration and particle deposition rate) (see Clause A.4);
f) considerations of any other performance requirements such as ESD or vibration;
g) temperature, humidity, processes and operator comfort considerations;
h) performance parameters and their acceptance criteria, with any specific requirements for alert
and action limits and their management;
i) entry and exit of personnel, equipment and materials, in terms of quantity, movement and controls
applied, such as decontamination and gowning;
j) sources of contamination and their source strength data;
k) methods of testing, measurement and monitoring to meet the acceptance criteria;
l) cleanroom environmental control by stand-alone systems or integrated into building management
system (BMS);
m) requirements for monitoring of environmental conditions and other parameters;
NOTE Guidance for monitoring to provide evidence of cleanroom performance related to air cleanliness
by particle concentration can be found in ISO 14644-2.
n) intended life cycle of the installation;
o) intended operational cycles and turn-down periods;
p) changes of the installation anticipated over time to be provided for in the design;
q) the intended location of the installation and any site constraints;
r) the identification of external environmental influences;
s) critical dimensions and weight restrictions, including those related to available space;
t) process and product requirements that affect the installation, including cleaning and disinfection;
u) the process equipment list with utility requirements;
v) the preferred contamination control concepts and overall strategy for contamination control;
w) environmental and energy efficiency targets;
x) process hazards;
y) internal cleanroom surface and finish requirements (including the need for smooth, impervious
finishes which are cleanable and resistant to cleaning and decontamination agents and free of gaps
or pathways to uncontrolled areas);
z) required availability in terms of acceptable downtime and back-up strategy in the event of failure;
aa) strategy of maintenance operations, space and time needed to maintain the installations during
the process cycle;
ab) any other factors or constraints, not listed above, imposed by the operating requirements over the
life cycle of the cleanroom;
ac) specific industry guidance.
Additional information on mechanisms of contamination and cleanliness attributes is given in Annex A,
together with a comprehensive checklist regarding requirements.
6.2 Other requirements
The following items shall be considered and defined as appropriate:
a) roles and responsibilities of all involved parties during execution of the project;
b) project budget;
c) a time schedule, including milestones for provision of necessary information and documentation;
d) procedure for managing changes;
e) verifications to be carried out at each stage of the project and related documentation;
f) acceptance criteria for the various project stages, if applicable;
g) scope of documentation at designated project stages, its data format and approval procedures (see
9.5);
h) training for cleanroom personnel and technical staff who will manage, use, clean, test and maintain
the installation;
i) any other approvals (e.g. management, financial, quality, process, regulatory, statutory);
j) competence and experience of designers, installers, constructors, commissioners and testers or
verifiers, specifically in relation to cleanrooms and cleanroom technology;
k) required experience, roles and responsibilities for approvals.
6.3 Documentation
The requirements shall be agreed and documented to form a basis for subsequent anticipated design
and allow changes to be managed in a traceable manner.
NOTE In some industries this is documented in a URS.
7 Design
7.1 General
The output of the requirements (Clause 6) is the input for the design. The design of the cleanroom shall
take into account an effective contamination control strategy for all aspects of its construction, testing,
operation, maintenance and life cycle. There are typically three stages in the overall design process:
conceptual design, basic design and detailed design.
Depending on the nature and scale of the project, these stages can be executed in one or more steps
with appropriate design iterations and reviews.
The design process shall progress in an agreed manner, shall take into account all the agreed
requirements and shall be documented.
Consideration shall be given to energy efficiency (see ISO 14644-16) and use of separative devices (see
ISO 14644-7).
Annex B gives additional information on contamination control concepts, calculation of air volume flow
rates for non-UDAF cleanrooms, selection of materials and layout.
Occupational health and safety shall be considered throughout the design stage.
In each design phase, the cost estimate and time schedule shall be considered. For cleanrooms, the clean
build stages and sequencing, construction method and verification shall also be considered.
7.2 Conceptual design
During the conceptual design, the contamination control concept(s) to be used shall be considered and
determined. Guidance about contamination control concepts can be found in Clause B.2.
The following shall be considered as an output of the conceptual design:
a) design criteria, approach and potential solutions for architectural, structural, civil, mechanical,
electrical, control and automation disciplines;
b) conceptual layouts of the installation, including locations and sizes of process equipment and
materials;
c) material, product, personnel and waste flow diagrams overlaid on the concept layouts with brief
descriptions;
d) specification of all environmental control requirements, including levels of air cleanliness,
airflow control concepts, temperature, relative humidity and room-pressure differentials or zone
segregation by airflow management;
e) preliminary calculations for performance parameters;
f) gowning specification to control source strength.
The conceptual design shall be reviewed by the customer and supplier to verify whether it meets the
established requirements (concept design verification).
Consequent to this review it will possibly be necessary to update the requirements. This is subject to
agreement.
At the completion of the conceptual design stage an agreed concept design document shall be produced.
7.3 Basic design
A basic design is developed based on the agreed concept design.
The following shall be considered for the basic design:
a) plan layout and section drawings, including locations and sizes of process equipment and materials;
b) room list with associated equipment identifying heat gain, potential for contamination and any
other critical characteristics;
c) utility list;
d) schematics, such as airflow diagrams, room air balance and pressurization plan;
e) material, product, personnel and waste flow diagrams overlaid on the developed layouts;
f) supporting calculations to support the supply and extract air volume flow rates necessary to
achieve required levels of air cleanliness, flow pressure cascade and recovery rate where required
(see Annex B);
g) supporting calculations associated with controlling any other contaminant of interest
(microorganisms, chemicals, nanoparticles or macroparticles in the air or on surfaces of interest);
h) associated design calculations for the HVAC environmental control system;
i) prefiltration and final air filtration and cleaning strategy for contaminants of interest, for
environment and for personnel;
j) functional description to provide a description of the sequence of operations for critical
performance parameters to aid controls system and software development;
k) any alternative designs considered, if applicable, and reasons for rejection;
l) energy-saving methods (as per ISO 14644-16);
m) automatic or manual system control to achieve the required airflow rate, airflow direction between
rooms and pressure cascade;
n) material and component specifications;
o) finishes and construction joint details for the surfaces of the installation;
p) commissioning (setting to work and verification) approach (see 8.2);
q) reliability and redundancy strategy;
r) maintenance strategy;
s) building automation and control systems, sometimes known as building management systems
(BMS).
The basic design shall be reviewed by customer and supplier to verify whether it meets the established
requirements and concept design (basic design verification). It is important to include the practicality
of both construction and maintenance in the review activity.
NOTE Consequent to review it will possibly be necessary to update the requirements. This is subject to
agreement.
At the end of the basic design stage an agreed basic design document(s) shall be produced.
7.4 Detailed design
The detailed design develops the agreed basic design. Upon completion of the detailed design stage
a detailed design document(s) shall be produced in sufficient depth to enable construction and
verification to be carried out.
The detailed design shall be reviewed as part of design verification to ensure it conforms to the
requirements in Clause 6 as implemented in the basic design. Any changes shall be approved by
stakeholders and recorded as part of change control and management.
In addition, the output of the detailed design stage shall include the quality control requirements for
the construction verification and commissioning, including the methods to be employed, the parties
involved and any requirements for witnessing.
7.5 Change management
When changes are necessary, during design or construction, the requirements or other inputs from the
prior design stages shall be referenced and may need to be refined or revised.
It is important that these changes and the implications of the changes are recorded, reviewed and
agreed to by designated personnel. Responsibility for this coordination shall be defined.
The impact of changes on cost, project schedule and quality shall be considered and approved.
8 Construction
8.1 General
The installation shall be constructed in accordance with the agreed detailed design and specifications
and the construction plan.
8.2 Construction plan
8.2.1 General
Roles, responsibilities and activities shall be described and assigned within the construction plan along
with a schedule, a quality plan and a clean build protocol.
All contractors’ and subcontractors’ activities shall be coordinated for the duration of the entire project.
Responsibility for this coordination shall be defined as a part of the construction plan.
8.2.2 S chedule
Construction activities shall be coordinated using a schedule that documents timing, sequence and key
milestones for the project.
8.2.3 Quality plan
A quality plan shall be developed in consultation with the customer and other relevant parties and shall
consider procedures for:
a) identifying changes that require an agreement;
b) identifying and documenting deviations;
c) assessing the impact of the consequences of these changes and deviations;
d) approval, by appropriate designated staff, of changes, deviations and corrective actions;
e) documenting the control of construction activities and information;
f) responsibility;
g) management of documentation.
NOTE Construction verifications can be part of the quality plan or exist as separate document(s), see 8.3.
8.2.4 Clean build protocol
A clean build protocol shall be considered for the construction project. Application across all
construction- and assembly-related activities both o
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