SIST EN ISO 14644-16:2019
(Main)Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)
Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)
This standard gives recommendations on reducing energy consumption and maintaining energy efficiency in new and existing cleanrooms and clean air devices, as classified by EN ISO 14644-1.
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
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
2
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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.
3
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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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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
f
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]
...
SLOVENSKI STANDARD
oSIST prEN ISO 14644-16:2018
01-julij-2018
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Cleanrooms and associated controlled environments - Part 16: Code of practice for
improving energy efficiency in cleanrooms and clean air devices (ISO/DIS 14644-
16:2018)
Reinräume und zugehörige Reinraumbereiche - Teil 16: Leitfaden zur Verbesserung der
Energieeffizienz von Reinräumen und Reinluftgeräten (ISO/DIS 14644-16:2018)
Salles propres et environnements maîtrisés apparentés - Partie 16: Code de bonnes
pratiques pour améliorer l'efficacité énergétique dans les salles propres et les dispositifs
à air épuré (ISO/DIS 14644-16:2018)
Ta slovenski standard je istoveten z: prEN ISO 14644-16
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-16:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14644-16:2018
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oSIST prEN ISO 14644-16:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-16
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2018-05-01 2018-07-24
Cleanrooms and associated controlled environments —
Part 16:
Code of practice for improving energy efficiency in
cleanrooms and clean air devices
Salles propres et environnements maîtrisés apparentés —
Partie 16: Code de bonnes pratiques pour améliorer l'efficacité énergétique dans les salles propres et les
dispositifs à air épuré
ICS: 13.040.35
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-16:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018
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oSIST prEN ISO 14644-16:2018
ISO/DIS 14644-16:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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oSIST prEN ISO 14644-16:2018
ISO/DIS 14644-16:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Installation . 3
3.3 Emission . 4
3.4 Energy efficiency . 5
3.5 Abbreviations . 6
4 Energy reduction evaluation and implementation process . 6
4.1 Introduction . 6
4.2 New or existing cleanrooms . 7
4.3 Energy performance comparison . 8
4.3.1 Compare energy performance . 8
4.3.2 Determine the business case . 8
4.3.3 Monitor and review . 8
4.4 Existing cleanroom retrofit or renovation . 8
4.5 Process for existing cleanrooms . 9
4.5.1 Select project team . 9
4.5.2 Review user requirements and project scope . 9
4.5.3 Collate information on cleanroom performance criteria .10
4.6 Process for design/construction of new build or updating cleanrooms .10
4.6.1 Review user requirements and project scope .10
4.6.2 Undertake energy performance design review .10
4.7 Comparative review of cleanroom environmental performance .10
4.8 Identify energy reduction opportunities .11
4.9 Assess the impact of energy reduction opportunities .11
4.10 Select energy reduction opportunities for implementation .11
4.11 Implementation .11
4.12 Monitor, review and feedback .12
4.13 Decommissioning .12
5 Impact of user requirement specification (URS) on energy consumption .12
5.1 Principle .12
5.2 Garment levels .12
6 Airflow volume and compensating factors .13
6.1 Airflow rate .13
6.2 Source strength and airflow rate calculation for non-unidirectional rooms .13
6.2.1 Determining airflow rate .13
6.2.2 Contaminant removal and ventilation effectiveness index .14
6.2.3 Compensation factors (C ) .14
f
6.3 A Flexible procedure for airflow rate estimation in non-UDAF rooms.15
6.3.1 General.15
6.3.2 Design stage .15
6.3.3 Testing stage .15
6.3.4 Operational stage .15
6.4 Airflow reduction for unidirectional rooms .16
7 Power management: Turn-down, turn-off and recovery .16
7.1 Turn-down .16
7.2 Turn-off .17
8 Adaptive control .17
© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 14644-16:2018
ISO/DIS 14644-16:2018(E)
9 Heating and cooling loads .17
10 Fan and filter selection .18
10.1 Air movement fans .18
10.2 Selection of air filters .18
11 Lighting levels .18
12 Training .18
13 Operation .19
14 Maintenance .20
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 .37
Annex F (informative) Critical area reduction example .39
Bibliography .40
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ISO/DIS 14644-16:2018(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 2.
The main task of technical committees is to prepare International Standards. 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 document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14644-16 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
A list of all parts in the ISO 14644- series, published under the general title Cleanrooms and associated
controlled environments, can be found on the ISO website.
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Introduction
Cleanrooms and associated controlled environments are widely used in many industries, such as
life-sciences (including pharmaceutical, medical device and hospital), micro-electronics, aerospace,
food processing and nuclear. Where applicable, regulation can override some recommendations.
Operational size ranges from decades to thousands of square meters, 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 part of ISO 14644
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.
[1]
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 part of 14644
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
[2]
mini-environments as described in ISO 14644-7. The standard 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 the text 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 upon 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
might 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.
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oSIST prEN ISO 14644-16:2018
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-16:2018(E)
Cleanrooms and associated controlled environments —
Part 16:
Code of practice for improving energy efficiency in
cleanrooms and clean air devices
1 Scope
This part of ISO 14644 gives guidance and recommendations for optimizing energy usage and
maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. The
standard provides guidance for the design, construction, commissioning and operation of cleanrooms.
It 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-2, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence
of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-3, Cleanrooms and associated controlled environments ‒ Part 3: Test methods
ISO 14644-4, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 14644-5, Cleanrooms and associated controlled environments — Part 5: Operations
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
air-handling unit
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, clean zone, controlled
zone or a defined location therein
[SOURCE: ISO 14644-1:2015, 3.1.4]
Note 1 to entry: Levels are expressed in terms of an ISO class, which represents maximum allowable
concentrations of contaminants in a unit volume of air.
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3.1.3
clean air device
stand-alone equipment for treating and distributing clean air to achieve defined environmental
conditions
[SOURCE: ISO 14644-4:2001, 3.2]
[2]
Note 1 to entry: Clean air devices include certain separative devices as defined in ISO 14644-7, for example,
clean air hoods, containment enclosures, gloveboxes, isolators and mini-environments.
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, 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 or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, airflow, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.1.6
controlled environment
defined zone in which sources of contamination are controlled by specified means
[SOURCE: ISO 14644-6:2007, 2.45]
3.1.7
final filter
last high-efficiency filter in the system before the air enters the cleanroom or clean zone
[SOURCE: ISO 14644-3:2005, 3.3.5]
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3.1.8
filter system
system composed of filter, frame and other support system or other housing
[SOURCE: ISO 14644-3:2005, 3.3.4]
3.1.9
pre-filter
air filter fitted upstream of another filter to reduce the challenge on that filter
[SOURCE: ISO 14644-4:2001, 3.8]
3.1.10
separative device
equipment utilizing constructional and dynamic means to create assured levels of separation between
the inside and outside of a defined volume
Note 1 to entry: This equipment can be used as a clean zone.
Note 2 to entry: Some industry-specific examples of separative devices are clean air hoods, containment
enclosures, glove boxes, isolators and mini-environments.
[SOURCE: ISO 14644-7:2004, 3.17]
3.2 Installation
3.2.1
adaptive control
capability of the system to modify its own operation parameters automatically to achieve the best
possible performances in various modes operations year-around
3.2.2
air change rate
rate of air exchange expressed as number of air changes per unit of time and calculated by dividing the
volume of air delivered in the unit of time by the volume of the cleanroom or clean zone
[SOURCE: ISO 14644-3:2005, 3.4.1]
3.2.3
diffuser
device placed on inlet air supply terminal to improve distribution of incoming air with room air
Note 1 to entry: A mesh grille or a perforated screen is not considered to be a diffuser.
3.2.4
non-unidirectional airflow (non-UDAF)
air distribution where the supply air entering the clean zone mixes with the internal air by means of
induction
[SOURCE: ISO 14644-4:2001, 3.6]
3.2.5
contaminant removal effectiveness (CRE)
ratio of particle concentration measured in the exhaust/return to the average of particle concentration
in the room, when particles entering from filtered supply air are ignored
[SOURCE: REHVA Guidebook No. 2]
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3.2.6
supply air volume flow rate
air volume supplied into a cleanroom through final filters or diffusers in unit of time
[SOURCE: ISO 14644-3:2005, 3.4.4]
3.2.7
terminal filter
air filter located at the point where the air enters the cleanroom
3.2.8
total air volume flow rate
air volume that passes through a section of a cleanroom in unit of time
[SOURCE: ISO 14644-3:2005, 3.4.5]
3.2.9
turn-down
controlled reduction of airflow velocity in unidirectional airflow (UDAF) 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
3.2.10
turn-off
controlled switching off of a part of an air-handling unit and/or clean air devices in cleanrooms in order
to save energy during periods when the cleanroom is not in operation
3.2.11
unidirectional airflow (UDAF)
controlled airflow through the entire cross section of a clean zone with a steady velocity and
approximately parallel airstreams
Note 1 to entry: This type of airflow results in a directed transport of particles from the clean zone to exit.
[SOURCE: ISO 14644-4:2001, 3.11]
3.3 Emission
3.3.1
emission
contaminants that are discharged from objects into the cleanroom indoor environment
[SOURCE: ISO 2889:2010, 3.30]
Note 1 to entry: For the purposes of this International Standard only particle and microorganism
...
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