Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)

Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-Inbetriebnahme (ISO 14644-4:2001)

Dieser Teil von ISO 14644 legt die Anforderungen für die Planung und die Ausführung von Reinraumanlagen (im Folgenden Reine Anlagen genannt) fest, schreibt jedoch keine spezifischen technischen oder vertraglichen Maßnahmen vor, um diese Anforderungen zu erreichen. Er ist für Auftraggeber, Lieferanten und Planer von Reinraumanlagen gedacht und beinhaltet eine Prüfliste mit wichtigen Leistungsanforderungen. Es wird eine Anleitung zur Ausführung einschließlich den Anforderungen für die Erst-Inbetriebnahme und Qualifizierung gegeben. Die grundlegenden Bestandteile von Planung und Ausführung, die zur Gewährleistung eines fortlaufenden und zufriedenstellenden Betriebs erforderlich sind, werden durch die Betrachtung der wesentlichen Aspekte von Betrieb und Instandhaltung identifiziert.
ANMERKUNG   Weitere Hinweise im Hinblick auf die obengenannten Anforderungen sind in den Anhängen A bis H aufgeführt. Weitere Teile von ISO 14644 können ergänzende Informationen enthalten.
Die Anwendung dieses Teils von ISO 14644 ist wie folgt eingeschränkt:
   Anwenderanforderungen werden durch den Auftraggeber oder Projektmanager vertreten.
   Besondere Prozesse, die in einer Reinraumanlage untergebracht werden sollen, werden nicht festgelegt.
   Brandschutz- und Sicherheitsmaßnahmen wurden nicht gesondert betrachtet; die nationalen und örtlich gegebenen Anforderungen sollten eingehalten werden.
   Prozess- und Betriebsmedienanschlüsse werden nur hinsichtlich ihrer Trassenführung zwischen und in den verschiedenen Reinheitsbereichen betrachtet.
   Bezüglich der Inbetriebnahme und Instandhaltung werden nur reinraumspezifische Anforderungen berücksichtigt.

Salles propres et environnements maîtrisés apparentés - Partie 4: Conception, construction et mise en fonctionnement (ISO 14644-4:2001)

La présente partie de l'ISO 14644 spécifie les exigences pour la conception et la construction d'installations de salles propres, mais elle ne prescrit nullement les moyens spécifiques technologiques ni contractuels permettant de satisfaire à ces exigences. Elle s'adresse aux acheteurs, fournisseurs et concepteurs des installations de salles propres et comprend une liste indicative de paramètres importants de performance. Des conseils en matière de construction sont proposés, accompagnés des exigences de mise en fonctionnement et de qualification. Les éléments de base de la conception et de la construction, nécessaires pour assurer le maintien d'un fonctionnement satisfaisant, sont identifiés par l'examen des aspects pertinents de l'exploitation et de la maintenance.
NOTE Des conseils complémentaires concernant les exigences ci-dessus sont fournis dans les annexes A à H. D'autres parties de l'ISO 14644 sont susceptibles de fournir des renseignements complémentaires. L'application de la présente partie de l'ISO 14644 est sujette aux limitations suivantes : - les exigences de l'utilisateur sont représentées par l'acheteur ou le prescripteur ; - des procédés spécifiques qu'hébergera l'installation de salle propre ne sont pas spécifiés ; - les règlements de sécurité et de protection incendie ne font pas l'objet d'un examen particulier; il convient de se conformer aux règlements nationaux ou locaux applicables; - on ne tient compte des fluides pour le procédé et des servitudes de raccordement et alimentations des systèmes que pour ce qui concerne le cheminement des réseaux entre, et à l'intérieur, des différentes zones de propreté ; - en ce qui concerne la mise en service et la maintenance, il n'est tenu compte que des exigences spécifiques aux salles propres.

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)

General Information

Status
Published
Publication Date
31-Dec-2001
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jan-2002
Due Date
01-Jan-2002
Completion Date
01-Jan-2002

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SLOVENSKI STANDARD
SIST EN ISO 14644-4:2002
01-januar-2002
Cleanrooms and associated controlled environments - Part 4: Design,
construction and start-up (ISO 14644-4:2001)

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

start-up (ISO 14644-4:2001)

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

Inbetriebnahme (ISO 14644-4:2001)
Salles propres et environnements maîtrisés apparentés - Partie 4: Conception,
construction et mise en fonctionnement (ISO 14644-4:2001)
Ta slovenski standard je istoveten z: EN ISO 14644-4:2001
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-4:2002 en

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

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SIST EN ISO 14644-4:2002
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SIST EN ISO 14644-4:2002
EUROPEAN STANDARD
EN ISO 14644-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2001
ICS 13.040.30
English version
Cleanrooms and associated controlled environments - Part 4:
Design, construction and start-up (ISO 14644-4:2001)

Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 4:

Partie 4: Conception, construction et mise en Planung, Ausführung und Erst-Inbetriebnahme (ISO 14644-

fonctionnement (ISO 14644-4:2001) 4:2001)
This European Standard was approved by CEN on 1 April 2001.

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 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 Management Centre has the same status as the official

versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,

Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-4:2001 E

worldwide for CEN national Members.
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SIST EN ISO 14644-4:2002
Page 2
EN ISO 14644-4:2001
CORRECTED 2003-03-26
Foreword

The text of the International Standard ISO 14644-4:2001 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 October 2001, and conflicting national

standards shall be withdrawn at the latest by October 2001.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of

the following countries are bound to implement this European Standard: Austria, Belgium,

Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,

Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United

Kingdom.
Endorsement notice
The text of the International Standard ISO 14644-4:2001 was approved by CEN as a
European Standard without any modification.

NOTE: Normative references to International Standards are listed in annex ZA (normative).

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SIST EN ISO 14644-4:2002
Page 3
EN ISO 14644-4:2001
Annex ZA
(normative)
Normative references to international publications with their corresponding
European publications

This European Standard incorporates, by dated or undated reference, provisions from other

publications. These normativereferences are cited at the appropriate places in the text, and the

publications are listed hereafter. For dated references, subsequent amendments to or revisions

of any of these publications apply to this European Standard only when incorporated in it by

amendment or revision. For undated references the latest edition of the publication referred to

applies (including amendments).

NOTE Where an International Publication has been modified bycommon modifications, indicated by

(mod.), the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 14644-1 1999 Cleanrooms and associated controlled EN ISO 14644-1 1999
environments — Part 1: Classification of air
cleanliness
ISO 14644-2 2000 Cleanrooms and associated controlled EN ISO 14644-2 2000
environments — Part 2: Specifications for
testing and monitoring to prove continued
compliance with ISO 14644-1
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SIST EN ISO 14644-4:2002
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SIST EN ISO 14644-4:2002
INTERNATIONAL ISO
STANDARD 14644-4
First edition
2001-04-01
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
Reference number
ISO 14644-4:2001(E)
ISO 2001
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)
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© ISO 2001

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ii © ISO 2001 – All rights reserved
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)
Contents

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

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

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

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

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

4 Requirements.................................................................................................................................................3

5 Planning and design......................................................................................................................................4

5.1 Planning procedure .......................................................................................................................................4

5.2 Design .............................................................................................................................................................5

6 Construction and start-up.............................................................................................................................5

7 Testing and approval.....................................................................................................................................6

7.1 General............................................................................................................................................................6

7.2 Construction approval ..................................................................................................................................6

7.3 Functional approval.......................................................................................................................................6

7.4 Operational approval.....................................................................................................................................6

8 Documentation...............................................................................................................................................6

8.1 General............................................................................................................................................................6

8.2 Record of an installation...............................................................................................................................6

8.3 Operational instructions ...............................................................................................................................6

8.4 Instructions for performance monitoring....................................................................................................7

8.5 Maintenance instructions .............................................................................................................................7

8.6 Maintenance record.......................................................................................................................................7

8.7 Record of operation and maintenance training..........................................................................................8

Annex A (informative) Control and segregation concepts......................................................................................9

Annex B (informative) Classification examples .....................................................................................................16

Annex C (informative) Approval of an installation.................................................................................................19

Annex D (informative) Layout of an installation.....................................................................................................23

Annex E (informative) Construction and materials................................................................................................27

Annex F (informative) Environmental control of cleanrooms ..............................................................................32

Annex G (informative) Control of air cleanliness...................................................................................................35

Annex H (informative) Additional specification of requirements to be agreed upon between

purchaser/user and designer/supplier ......................................................................................................37

Bibliography..............................................................................................................................................................50

© ISO 2001 – All rights reserved iii
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO

member bodies). The work of preparing International Standards is normally carried out through ISO technical

committees. Each member body interested in a subject for which a technical committee has been established has

the right to be represented on that committee. International organizations, governmental and non-governmental, in

liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical

Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.

Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this part of ISO 14644 may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 14644-4 was prepared by Technical Committee ISO/TC 209, Cleanrooms and

associated controlled environments.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled

environments:
� Part 1: Classification of air cleanliness

� Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

� Part 3: Metrology and test methods
� Part 4: Design, construction and start-up
� Part 5: Operations
� Part 6: Vocabulary

� Part 7: Separative enclosures (clean air hoods, glove boxes, isolators, mini-environments)

Users should note that the titles listed for parts 3 and 5 to 7 are working titles at the time of the release of part 4. In

the event that one or more of these parts are deleted from the work programme, the remaining parts may be

renumbered.
Annexes A to H of this part of ISO 14644 are for information only.
iv © ISO 2001 – All rights reserved
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)
Introduction

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

This part of ISO 14644 specifies the requirements for the design and construction of cleanroom facilities. It is

intended for use by purchasers, suppliers and designers of cleanroom installations and provides a check list of

important parameters of performance. Construction guidance is provided, including requirements for start-up and

qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are

identified through the consideration of relevant aspects of operation and maintenance.

This part of ISO 14644 is one of a series of standards concerned with cleanrooms and associated subjects. Many

factors besides design, construction and start-up should be considered in the operation and control of cleanrooms

and other controlled environments. These are covered in some detail in other International Standards prepared by

ISO/TC 209.
© ISO 2001 – All rights reserved v
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SIST EN ISO 14644-4:2002
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SIST EN ISO 14644-4:2002
INTERNATIONAL STANDARD ISO 14644-4:2001(E)
Cleanrooms and associated controlled environments
Part 4:
Design, construction and start-up
1 Scope

This part of ISO 14644 specifies requirements for the design and construction of cleanroom installations but does

not prescribe specific technological or contractual means to meet these requirements. It is intended for use by

purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of

performance. Construction guidance is provided, including requirements for start-up and qualification. Basic

elements of design and construction needed to ensure continued satisfactory operation are identified through the

consideration of relevant aspects of operation and maintenance.

NOTE Further guidance in respect of the above requirements is given in annexes A to H. Other parts of ISO 14644 may

provide complementary information.
Application of this part of ISO 14644 is restricted in the following:
� user requirements are represented by purchaser or specifier;

� specific processes to be accommodated in the cleanroom installation are not specified;

� fire and safety regulations are not considered specifically; the appropriate national and local requirements

should be respected;

� process media and utility services are only considered with respect to their routing between and in the different

zones of cleanliness;

� regarding initial operation and maintenance, only cleanroom construction-specific requirements are

considered.
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 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness.

ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing and

monitoring to prove continued compliance with ISO 14644-1.
© ISO 2001 – All rights reserved 1
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)

ISO 14644-3:— , Cleanrooms and associated controlled environments — Part 3: Metrology and test methods.

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

Part 1: General principles

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

Part 2: Evaluation and interpretation of biocontamination data.

ISO 14698-3:— , Cleanrooms and associated controlled environements — Biocontamination control —

Part 3: Measurement of the efficiency of processes of cleaning and/or disinfection of inert surfaces bearing

biocontaminated wet soiling or biofilms.
3 Terms and definitions

For the purposes of this part of ISO 14644, the terms and definitions given in ISO 14644-1 and the following apply.

3.1
changing room

room where people using a cleanroom may change into, or out of, cleanroom apparel

3.2
clean air device

stand-alone equipment for treating and distributing clean air to achieve defined environmental conditions

3.3
cleanliness

condition of a product, surface, device, gas, fluid, etc. with a defined level of contamination

NOTE Contamination can be particulate, non-particulate, biological, molecular or of other consistency.

3.4
commissioning

planned and documented series of inspections, adjustments and tests carried out systematically to set the

installation into correct technical operation as specified
3.5
contaminant

any particulate, molecular, non-particulate and biological entity that can adversely affect the product or process

3.6
non-unidirectional airflow

air distribution where the supply air entering the clean zone mixes with the internal air by means of induction

3.7
particle
minute piece of matter with defined physical boundaries
NOTE For classification purposes refer to ISO 14644-1.
3.8
pre-filter

air filter fitted upstream of another filter to reduce the challenge on that filter

To be published.
2 © ISO 2001 – All rights reserved
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)
3.9
process core

location at which the process and the interaction between the environment and the process occurs

3.10
start-up

act of preparing and bringing an installation into active service, including all systems

EXAMPLE Systems may include procedures, training requirements, infrastructure, support services, statutory under-

takings requirements.
3.11
unidirectional airflow

controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately parallel

streamlines

NOTE This type of airflow results in a directed transport of particles from the clean zone.

4 Requirements

4.1 The parameters listed in 4.2 to 4.18 shall be defined and agreed between purchaser and supplier:

NOTE In the requirements stated below, references are made to annexes A to H which are for information only.

4.2 The number, edition and date of publication of this part of ISO 14644 shall be given.

4.3 The role of other relevant parties to the project (e.g. consultants, designers, regulatory authorities, service

organizations) shall be established (see examples in annex C).

4.4 The general purpose for which the cleanroom is to be used, the operations to be carried out therein and any

constraint imposed by the operating requirements (see examples in annexes A, B and D).

4.5 The required airborne particulate cleanliness class or demands for cleanliness in accordance with the

relevant International Standard (ISO 14644-1, ISO 14698-1, ISO 14698-2 and ISO 14698-3) (see examples in

annex B).

4.6 The critical environmental parameters, including their specified set points, alert and action levels to be

measured to ensure compliance, together with the measurement methods to be used, including calibration

(ISO 14644-2 and ISO 14644-3) (see examples in annex F).

4.7 The contamination control concept, including installation, operating and performance criteria, to be used to

achieve the required cleanliness level (see examples in annex A).

4.8 The methods of measurement, control, monitoring and documentation required to meet the parameters

agreed (see examples in annexes C and F).

4.9 The entry or exit of equipment, apparatus, supplies and personnel required to support the installation (see

examples in annex D).

4.10 The specified occupancy states selected from "as-built", "at-rest" and "operational" under which the required

parameters shall be achieved and maintained including variations with time, and the methods of control (see

examples in annex C).
4.11 The layout and configuration of the installation (see examples in annex D).

4.12 Critical dimensions and mass restrictions, including those related to available space (see examples in

annex D).
© ISO 2001 – All rights reserved 3
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)

4.13 The process and product requirements that affect the installation (see examples in annexes B and G).

4.14 The process equipment list with utility requirements (see examples in annexes D, E and H).

4.15 The maintenance requirements of the installation (see examples in annexes D and E).

4.16 The assignment of tasks for the preparation, approval, execution, supervision, documentation, statement of

criteria, basis of design, detailed design, construction, testing, commissioning and qualification (including the

performance and witnessing) of tests (see examples in annexes E and G).

4.17 The identification and evaluation of external environmental influences (see examples in annex H).

4.18 Additional information required by the particular application (see examples in annex H).

5 Planning and design
5.1 Planning procedure

5.1.1 A project plan shall be developed, in consultation with the user and all other involved parties, to define the

requirements of the products, the processes and the scope of the installation.

5.1.2 In order to determine the needs of an installation, a process equipment list shall be compiled, and shall

include the critical requirements for each piece of process equipment.

5.1.3 Diversity factors shall be defined, considering peak and average demand for each utility and environmental

control system.

NOTE A system may include multiple subsystems which require individual diversity-factor determination.

5.1.4 A contamination control concept shall be developed for each zone of an installation (see examples in

annex A).

5.1.5 The specifications as defined in clause 4 shall be reviewed and refined based on financial and timescale

requirements.
5.1.6 The project plan shall include the following elements:
a) design documentation with support calculations;
b) cost evaluation;
c) timescale evaluation;
d) an outline of anticipated project complications;

e) design options with records of advantages and disadvantages and any recommendations;

f) a review of maintenance requirements of the installation;
g) a review of the degree of flexibility to be included in the installation;
h) a review of the stand-by capacities to be included in the installation;
i) a review of the constructability of the design of the installation;
j) a quality plan.
4 © ISO 2001 – All rights reserved
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)

The use of a quality system, such as the ISO 9000 family of international standards (e.g. ISO 9000 and

ISO 9001), should be considered, in conjunction with industry-specific quality assurance strategies.

5.1.7 The completed project plan shall be reviewed and agreed upon between purchaser and supplier.

5.2 Design

5.2.1 The design shall accommodate all of the relevant product and process requirements in conjunction with the

selected contamination control concept (see examples in annex A).

5.2.2 The purchaser and supplier shall formally accept the design in accordance with predetermined acceptance

criteria.

5.2.3 The design shall conform to an agreed list of requirements, such as building, environmental and safety

regulations, good manufacturing practice guidelines (e.g. ISO 14001 and ISO 14004).

The design should be reviewed at periodic stages of development, including final completion, to ensure compliance

with the specifications and the acceptance criteria.
6 Construction and start-up

6.1 Construction of an installation shall comply with the drawings and specifications.

6.2 Any changes required during the course of construction shall be checked for acceptance, approved and

documented prior to implementation of the change in accordance with a change control procedure.

6.3 Construction work, whether performed at a manufacturing location or in situ, shall observe the specific

contamination control requirements of the quality plan.

6.4 A clean construction protocol and cleaning procedures shall be developed as part of the quality plan and

enforced to achieve the specified contamination control requirements. Security and access control is essential to

maintain the clean construction protocol.

6.5 The cleaning methods and methods to determine and approve the achieved cleanliness shall be defined and

documented in the quality plan.

6.6 The cleaning of the air systems shall be specified and shall be carried out at assembly, before initial

operation and whenever rebuilding work, repair work and maintenance work are performed.

6.7 In the case of start-up of new installations or re-starting existing installations after repair or modification, final

cleaning of the cleanroom is necessary and provisions shall be made for the removal of adherent, imported or

released contamination.

6.8 Before commencing any operational activities, the complete and satisfactory function of the installation shall

be determined by tests carried out in accordance with clause 7.

NOTE In the case of packaged units, such as clean air devices, a manufacturer's certificate of compliance with the

requirements of this part of ISO 14644 may be sufficient, provided that the supplier is qualified (i.e. knowledgeable of or

competent in cleanroom requirements) and the risk of damage during transport, storage and installation can be controlled

adequately.

6.9 During acceptance testing, commissioning and initial operation, the personnel in charge of the installation

shall be trained. Testing, approval of the installation and training shall include all relevant practices for proper

cleanroom operation, maintenance and in-process control. The responsibility for providing training shall be defined.

When training is carried out, all relevant persons such as operators, maintenance and service personnel should be

included.
© ISO 2001 – All rights reserved 5
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SIST EN ISO 14644-4:2002
ISO 14644-4:2001(E)
7 Testing and approval
7.1 General

During and upon completion of the construction of an installation, an agreed series of documented tests shall be

specified and undertaken prior to operational use of the installation. Annex C gives examples of the design, testing

and approval pro
...

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