EN ISO 14644-16:2019

Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms.
This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications.
It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

Reinräume und zugehörige Reinraumbereiche - Teil 16: Energieeffizienz von Reinräumen und Reinluftgeräten (ISO 14644-16:2019)

Dieses Dokument legt ein Verfahren zur Bestimmung der einzelnen Glucosinolate in Rapssamen und Rapsschrot mittels Hochleistungsflüssigkeitschromatographie mit Gradientenelution fest.
Dieses Verfahren wurde an Rapssamen und Rapsschrot (Brassica rapa, Brassica napus und Brassica juncea) geprüft, ist jedoch auf andere Pflanzenmaterialien unter der Bedingung anwendbar, dass die vorkommenden Glucosinolate zuvor identifiziert wurden und in diesem Dokument beschrieben sind. Die quantitative Bestimmung des (der) betreffenden Glucosinolats (Glucosinolate) wird nicht durchgeführt.
ANMERKUNG   Glucosinolate, die am Glucosemolekül substituiert sind, werden mit diesem Verfahren nicht erfasst, sind für handelsübliche Rapssamen und Rapsschrot jedoch auch von untergeordneter Bedeutung.
Anhang A enthält die Ergebnisse der Ringversuche für das HPLC Verfahren mit Gradientenelution. Anhang B stellt dar, wie der Titer der hergestellten internen Standardlösung überprüft wird. Anhang C stellt dar, wie die gereinigte Sulfatase Lösung hergestellt und geprüft wird und wie der Desulfatierungsschritt an der Ionenaustauschersäule überprüft wird. Anhang D stellt die Qualifikation der HPLC- und Säulenleistungs¬kriterien dar.
Die Analyse des Glucosinolatgehalts in Rapssamen kann auch unter Anwendung eines isokratischen Elutionsmodus erfolgen. Das erfordert einige Modifikationen des Verfahrens (interner Standard, HPLC Säule und HPLC Pufferlösungen), wie in Anhang E beschrieben.

Salles propres et environnements maîtrisés apparentés - Partie 16: Efficacité énergétique dans les salles propres et les dispositifs séparatifs (ISO 14644-16:2019)

Le présent document donne des lignes directrices et recommandations relatives à l'optimisation de la consommation énergétique et au maintien de l'efficacité énergétique dans les salles propres nouvelles et existantes, les zones propres et les dispositifs séparatifs. Il fournit des recommandations relatives à la conception, la construction, la mise en service et l'exploitation des salles propres.
Il couvre toutes les caractéristiques spécifiques aux salles propres et peut être utilisé dans différents domaines pour optimiser l'usage énergétique dans les industries électronique, aérospatiale, nucléaire, pharmaceutique, établissements de santé, des dispositifs médicaux et agroalimentaires, ainsi que dans d'autres applications à air propre.
Il intègre également le concept d'analyse comparative des performances pour l'évaluation des performances et la comparaison des efficacités énergétiques des salles propres, tout en maintenant les niveaux de performance aux exigences de l'ISO 14644[2][3].

Čiste sobe in podobna nadzorovana okolja - 16. del: Učinkovita raba energije v čistih sobah in zaprtih enotah (ISO 14644-16:2019)

Ta standard podaja priporočila za zmanjšanje porabe energije in vzdrževanje učinkovite rabe energije v novih in obstoječih čistih sobah ter napravah s čistih zrakom, kot je določeno s standardom EN ISO 14644-1.

General Information

• Status: Published
• Publication Date: 18-Jun-2019
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Due Date: 19-Jun-2019
• Completion Date: 19-Jun-2019
• Ref Project: SIST EN ISO 14644-16:2019 - Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-16:2019
01-september-2019
Čiste sobe in podobna nadzorovana okolja - 16. del: Učinkovita raba energije v
čistih sobah in zaprtih enotah (ISO 14644-16:2019)

Cleanrooms and associated controlled environments - Part 16: Energy efficiency in

cleanrooms and separative devices (ISO 14644-16:2019)
Reinräume und zugehörige Reinraumbereiche - Teil 16: Energieeffizienz von
Reinräumen und Reinluftgeräten (ISO 14644-16:2019)
Salles propres et environnements maîtrisés apparentés - Partie 16: Efficacité

énergétique dans les salles propres et les dispositifs séparatifs (ISO 14644-16:2019)

Ta slovenski standard je istoveten z: EN ISO 14644-16:2019
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-16:2019 en,fr,de

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

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SIST EN ISO 14644-16:2019
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SIST EN ISO 14644-16:2019
EN ISO 14644-16
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2019
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
16: Energy efficiency in cleanrooms and separative devices
(ISO 14644-16:2019)

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

- Partie 16: Efficacité énergétique dans les salles 16: Energieeffizienz von Reinräumen und

propres et les dispositifs séparatifs (ISO 14644- Reinluftgeräten (ISO 14644-16:2019)

16:2019)
This European Standard was approved by CEN on 30 May 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-16:2019 E

worldwide for CEN national Members.
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SIST EN ISO 14644-16:2019
EN ISO 14644-16:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 14644-16:2019
EN ISO 14644-16:2019 (E)
European foreword

This document (EN ISO 14644-16:2019) has been prepared by Technical Committee ISO/TC 209

"Cleanrooms and associated controlled environments" in collaboration with Technical Committee

CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by December 2019, and conflicting national standards

shall be withdrawn at the latest by December 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

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

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

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

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 14644-16:2019 has been approved by CEN as EN ISO 14644-16:2019 without any

modification.
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SIST EN ISO 14644-16:2019
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SIST EN ISO 14644-16:2019
INTERNATIONAL ISO
STANDARD 14644-16
First edition
2019-05
Cleanrooms and associated controlled
environments —
Part 16:
Energy efficiency in cleanrooms and
separative devices
Salles propres et environnements maîtrisés apparentés —
Partie 16: Efficacité énergétique dans les salles propres et les
dispositifs séparatifs
Reference number
ISO 14644-16:2019(E)
ISO 2019
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SIST EN ISO 14644-16:2019
ISO 14644-16:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 14644-16:2019
ISO 14644-16:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

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

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

3 Terms and definitions ..................................................................................................................................................................................... 1

3.1 General terms ........................................................................................................................................................................................... 1

3.2 Terms related to installation ....................................................................................................................................................... 3

3.3 Terms related to energy efficiency ......... ................................................................................................................................ 4

3.5 Abbreviated terms ............................................................................................................................................................................... 4

4 Energy reduction evaluation and implementation process .................................................................................... 5

4.1 General ........................................................................................................................................................................................................... 5

4.2 New or existing cleanrooms ........................................................................................................................................................ 6

4.3 Energy performance comparison ........................................................................................................................................... 7

4.3.1 General...................................................................................................................................................................................... 7

4.3.2 Compare energy performance ............................................................................................................................. 7

4.3.3 Determine the business case ................................................................................................................................. 7

4.3.4 Monitor and review ....................................................................................................................................................... 7

4.4 Existing cleanroom retrofit or renovation ...................................................................................................................... 7

4.5 Process for existing cleanrooms .............................................................................................................................................. 8

4.5.1 Select project team ......................................................................................................................................................... 8

4.5.2 Review user requirements and project scope ........................................................................................ 8

4.5.3 Collate information on cleanroom performance criteria .............................................................. 9

4.6 Process for design/construction of new build or updating cleanrooms .............................................. 9

4.6.1 Review user requirements and project scope ........................................................................................ 9

4.6.2 Undertake energy performance design review ..................................................................................... 9

4.7 Comparative review of cleanroom environmental performance ................................................................ 9

4.8 Identify energy reduction opportunities .......................................................................................................................10

4.9 Assess the impact of energy reduction opportunities .......................................................................................10

4.10 Select energy reduction opportunities for implementation .........................................................................10

4.11 Implementation ...................................................................................................................................................................................10

4.12 Monitor, review and feedback .................................................................................................................................................11

4.13 Decommissioning ..............................................................................................................................................................................11

5 Impact of user requirement specification (URS) on energy consumption ...........................................11

5.1 Principle .....................................................................................................................................................................................................11

5.2 Garment levels ......................................................................................................................................................................................11

6 Airflow volume and compensating factors .............................................................................................................................12

6.1 Fresh air supply ...................................................................................................................................................................................12

6.2 Airflow volume rate .........................................................................................................................................................................12

6.3 Source strength and airflow rate calculation for non-unidirectional rooms ..................................12

6.3.1 Determining air volume flow rate ..................................................................................................................12

6.3.2 Ventilation effectiveness index .........................................................................................................................13

6.3.3 Compensation factors (C ) ....................................................................................................................................13

6.4 Flexible procedure for airflow rate estimation in non-UDAF rooms.....................................................14

6.4.1 General...................................................................................................................................................................................14

6.4.2 Design stage ......................................................................................................................................................................14

6.4.3 Testing stage .....................................................................................................................................................................15

6.4.4 Operational stage .........................................................................................................................................................15

6.5 Air velocity reduction for unidirectional air flow systems. ...........................................................................15

7 Power management: turn-down, turn-off and recovery. ..........................................................................................15

7.1 Turn-down ...............................................................................................................................................................................................15

7.2 Turn-off ......................................................................................................................................................................................................16

© ISO 2019 – All rights reserved iii
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SIST EN ISO 14644-16:2019
ISO 14644-16:2019(E)

8 Adaptive control .................................................................................................................................................................................................16

9 Heating and cooling loads ........................................................................................................................................................................17

10 Fan and filter selection ................................................................................................................................................................................17

10.1 Air movement fans ............................................................................................................................................................................17

10.2 Selection of air filters ......................................................................................................................................................................17

11 Lighting levels .......................................................................................................................................................................................................18

12 Training .......................................................................................................................................................................................................................18

13 Operation ..................................................................................................................................................................................................................18

14 Maintenance ...........................................................................................................................................................................................................19

15 Decommissioning .............................................................................................................................................................................................20

Annex A (informative) Source strength: Air volume and worked example ...............................................................21

Annex B (informative) Energy saving opportunities ........................................................................................................................26

Annex C (informative) Impact assessment ..................................................................................................................................................32

Annex D (informative) Benchmarking: Energy performance indicators for cleanrooms ..........................33

Annex E (informative) Useful measures to minimize excess heating and cooling losses or gains ....38

Annex F (informative) Critical area reduction example ................................................................................................................40

Bibliography .............................................................................................................................................................................................................................42

iv © ISO 2019 – All rights reserved
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SIST EN ISO 14644-16:2019
ISO 14644-16:2019(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.

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.
A list of all parts in the ISO 14644 series can be found on the ISO website.
© ISO 2019 – All rights reserved v
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SIST EN ISO 14644-16:2019
ISO 14644-16:2019(E)
Introduction

Cleanrooms and associated controlled environments are widely used in many industries, such as

life-sciences (including pharmaceutical, medical device), micro-electronics, aerospace, food processing,

nuclear and hospitals. Operational size ranges from tens to thousands of square metres, most with unique

design and operational characteristics based on their function. Their development has involved rapid

expansion and progress for several decades, mirrored by an increasing energy demand. This document

embraces the accumulated experiences and practices in cleanroom design, operation and maintenance,

formulated to reduce their energy consumption and the global impact of this dramatic growth.

Users are also referred to ISO 50001 for energy management.

Although varying greatly in function and size, the energy consumption of cleanrooms can be over

10 times higher than that for offices of similar size. A considerable amount of energy is required to

provide large amounts of filtered and conditioned air to achieve specific levels of air cleanliness. Air

movement fans can account for 35 % to 50 % of the HVAC consumption of cleanrooms due to the power

required to overcome the high pressure differentials needed to operate high-efficiency filters and

other circulation components in the cleanroom system. Production of this type of high-quality air can

consume up to 80 % of the total energy used in a typical manufacturing facility.

Additional energy is also used to achieve temperature and relative humidity control for processes in

the cleanroom, for personnel comfort and to achieve the requisite pressurization of the cleanroom

space. There is therefore significant potential for energy saving by diligent design in the installation of

new cleanrooms, and by retrofit improvements and upgrades to existing facilities. This document sets

out the measures that can be taken to introduce these techniques and applies to the full spectrum of

“cleanroom technology”, from cleanrooms to clean air devices, including isolators, glove boxes and mini-

[1]

environments as described in ISO 14644-7 . This document is based on actual experience, practice

and tests supported by theoretical calculations for the purpose of clear and scientific description of the

effects of energy saving.

The energy saving methods and techniques used in this document are all general ones applicable to

varied environments and situations. They are not process-specific and exclude related production

processes such as water treatment, and oven, autoclave and stress cycling operations. Their specific

application depends on the actual conditions of cleanroom operation as agreed between the customer,

the supplier and the installation engineers.

At each stage in the cleanroom life cycle, opportunities exist to optimize system performance and

reduce energy consumption. Energy saving measures implemented at the design stage achieve the most

effective results for new cleanrooms, but similar energy savings can also be achieved for those currently

in operation. Cleanrooms can be used singly or as a group, based on practical conditions on site.

During design, when information about the finished building and process is at its minimum,

conservatism can dictate the oversizing of systems and the mandating of overly tight specifications. At

this stage, challenging these specifications and design considerations is valuable for energy efficiency.

When setting the system to work and executing performance testing, there is an opportunity to adjust

the system to accommodate the actual conditions as built to optimize the system performance and

minimize energy usage.

During the operating life of the facility, analysis of monitoring data can and should be used to

further optimize system performance and minimize energy usage.
vi © ISO 2019 – All rights reserved
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SIST EN ISO 14644-16:2019
INTERNATIONAL STANDARD ISO 14644-16:2019(E)
Cleanrooms and associated controlled environments —
Part 16:
Energy efficiency in cleanrooms and separative devices
1 Scope

This document gives guidance and recommendations for optimizing energy usage and maintaining

energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides

guidance for the design, construction, commissioning and operation of cleanrooms.

This document covers all cleanroom-specific features and can be used in different areas to optimize

energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries

and other clean air applications.

It also introduces the concept of benchmarking for the performance assessment and comparison of

[2][3]

cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements .

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 50001, Energy management systems — Requirements with guidance for use
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 50001 and the following 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 http: //www .electropedia .org/
3.1 General terms
3.1.1
air-handling unit
AHU

unit or plant, comprising fan, filtration, heating, cooling and mixing of fresh air and recirculated air,

that delivers conditioned air to a room or facility
3.1.2
classification

method of assessing level of cleanliness against a specification for a cleanroom (3.1.4), clean zone (3.1.5),

controlled zone or a defined location therein

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, modified — In the definition, the part after “clean zone” has

been added.]
© ISO 2019 – All rights reserved 1
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SIST EN ISO 14644-16:2019
ISO 14644-16:2019(E)
3.1.3
clean air device

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

conditions
[1]

Note 1 to entry: Clean air devices include certain separative devices (3.1.7) as defined in ISO 14644-7 , for

example, clean air hoods, containment enclosures, gloveboxes, isolators and mini-environments.

[SOURCE: ISO 14644-4:2001, 3.2, modified — Note 1 to entry has been added.]
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 are also

specified and controlled subject to application.

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

humidity, pressure, airflow, 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 (3.1.4) or can be achieved by a

separative device (3.1.7). Such a device can be located inside or outside a cleanroom.

Note 4 to entry: Other relevant physical parameters can also be controlled as required, e.g. temperature,

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