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 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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 14644-16:2019(E)
© 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.
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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 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
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 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
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 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]
3.1.6
pre-filter
air filter fitted upstream of another filter to reduce the challenge on that filter
[SOURCE: ISO 14644-4:2001, 3.8]
3.1.7
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 (3.1.5).
Note 2 to entry: Some industry-specific examples of separative devices are clean air hoods, containment
enclosures, glove boxes, isolators and mini-environments.
2 © ISO 2019 – All rights reserved
ISO 14644-16:2019(E)
[SOURCE: ISO 14644-7:2004, 3.17, modified — Note 1 to entry has been replaced, and former Note 1 to
entry has been renumbered accordingly.]
3.2 Terms related to 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 (3.1.4) or clean zone (3.1.5)
[SOURCE: ISO 14644-3:2005, 3.4.1, modified — In the definition, “space” has been replaced by
“cleanroom or clean zone”.]
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 (3.1.5) 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]
3.2.6
air volume flow rate
supply airflow rate
air volume supplied into an installation from final filters or air ducts in unit of time
[SOURCE: ISO 14644-3:2005, 3.4.5, modified — "air volume flow rate" has been added as main term.]
3.2.7
air change effectiveness
ACE
ratio between the recovery rate at a location or locations in a cleanroom (3.1.4) and the overall recovery
rate of the cleanroom after a contamination event
[6]
Note 1 to entry: The recovery rate is defined and measured in accordance with ISO 14644-3 .
3.2.8
turn-down
controlled reduction of airflow velocity in unidirectional airflow (3.2.9) cleanrooms (3.1.4) and clean air
devices (3.1.3) or airflow rates in non‑UDAF (3.2.4) cleanrooms in order to save energy during periods
when the cleanroom is not in operation
ISO 14644-16:2019(E)
3.2.9
unidirectional airflow
UDAF
controlled airflow through the entire cross-section of a clean zone (3.1.5) 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, modified — In the definition, “streamlines” has been replaced by
“airstreams”, and “to exit” has been added at the end of Note 1 to entry.]
3.2.10
emission
amount of contaminants that is discharged from objects into the cleanroom (3.1.4) air
3.2.11
source strength
rate describing the number of particles or colony-forming units emitted from an object per time unit
Note 1 to entry: A source can be a person, equipment or an object.
3.2.12
microbe-carrying particle
particle on which a microorganism is carried, normally dispersed into room air by personnel as a skin
cell, or fragment of skin cell, on which a skin microbe(s) is carried
3.3 Terms related to energy efficiency
3.3.1
benchmarking
comparative evaluation and/or analysis of similar operational practices
3.3.2
energy cost
total financial cost of the energy consumed, related to the area being investigated
3.3.3
power
time rate at which work is done or energy is transferred
Note 1 to entry: The SI unit of power is the watt (W) or joule per second (J/s).
3.5 Abbreviated terms
CFD computational fluid dynamics
EMS environmental management system
FFU fan filter unit
HSE health, safety and environment
HVAC heating, ventilation and air conditioning
RH relative humidity
4 © ISO 2019 – All rights reserved
ISO 14644-16:2019(E)
SFP specific fan power
URS user requirement specification
VE ventilation effectiveness
4 Energy reduction evaluation and implementation process
4.1 General
The energy consumption of cleanrooms, clean zones and separative devices can be reduced in
accordance with 4.2 to 4.13, following the process shown in Figure 1.
Figure 1 summarizes the process that can be used for a typical cleanroom including its airflow system
shown in Figure 2. It covers existing cleanrooms in operation, existing cleanrooms that are being
modified and new build cleanrooms in the design phase.
ISO 14644-16:2019(E)
Figure 1 — Systematic approach to energy saving — Project work flow
4.2 New or existing cleanrooms
The process of reducing energy consumption of new and existing cleanrooms differ because the starting
point and data available are different.
6 © ISO 2019 – All rights reserved
ISO 14644-16:2019(E)
The recommendations of 4.5 and 4.6 should be followed if a new cleanroom is being designed or an
existing cleanroom is being assessed for energy reduction purposes.
If an existing cleanroom is planned to be refurbished, then there might be other opportunities to reduce
energy consumption that can be incorporated in the modifications.
4.3 Energy performance comparison
4.3.1 General
The process of reducing energy consumption in existing cleanrooms can require the time involvement
of many resources and there is a cost associated with this activity. For this reason, it is important
to establish the cleanroom significant energy use (SEU) that justifies the reduction activity (see
ISO 50001).
4.3.2 Compare energy performance
Assess the current energy performance of the cleanroom and compare to a suitable comparator
or benchmark. Example comparators can include another similar cleanroom facility, previous
commissioning data where energy performance had previously been optimized, or a calculated
comparator-based on previous experience. Guidance on benchmarking energy performance is given in
Annex D.
4.3.3 Determine the business case
Establish if the difference between the current cleanroom energy consumption and energy cost, and
the comparator or benchmark is significant and would justify further investment of time and resources.
4.3.4 Monitor and review
If there is no justification at the current point in time, continue to monitor energy performance at
regular intervals and reassess the energy performance in comparison to the benchmark. Over time, a
number of variables can change which can change this assessment:
— cleanroom energy performance and efficiency can degrade;
— the unit cost of energy and project implementation costs can change, which will change the project
economics; and
— new technologies can become available or more viable.
4.4 Existing cleanroom retrofit or renovation
The design of the cleanroom to be refurbished should be reviewed to ensure energy efficiency is
considered in the design. The air handling and distribution system for a typical room is shown below.
ISO 14644-16:2019(E)
SOURCE ASPEC-ADEME-EDF. Energy performance in clean zones (cleanrooms, controlled environments,
[5]
contained areas) , reproduced with the permission of ASPEC France.
Figure 2 — Illustration of typical cleanroom air handling and distribution
The design should enable future regulation and optimization of cleanroom energy performance, for
example, installation of variable speed drives for fan motors.
4.5 Process for existing cleanrooms
4.5.1 Select project team
Those selected for the project team should be sufficiently knowledgeable to provide expertise on
the following aspects: engineering and maintenance of cleanroom equipment/utilities, cleanroom
energy consumption, product quality, equipment/process validation, production operations, and
health and safety.
The team can consist of any number of members.
4.5.2 Review user requirements and project scope
The project team should understand the cleanroom operation and document the scope of the energy
reduction project. This can include:
— overall objective of the cleanroom (its purpose);
— critical process parameters required to be maintained within the cleanroom.
EXAMPLE Temperature and relative humidity ranges, room cleanliness requirement, recovery time and
pressure differentials between adjacent rooms of different classification.
8 © ISO 2019 – All rights reserved
ISO 14644-16:2019(E)
4.5.3 Collate information on cleanroom performance criteria
Documents, including drawings and specifications, and information that define the cleanroom
performance criteria should be collated to:
a) identify criteria that affect performance and consider the direct and indirect impacts of possible
energy reduction actions;
b) identify the cleanroom performance criteria to meet the requirements of the process, the products
personnel safety and comfort;
c) build a profile of energy use, covering lighting, air handling, comfort heating, cooling and any other
significant energy use, or where this is not possible use professionally derived estimates;
d) determine the current cleanliness performance (from classification and monitoring: particles,
chemicals and microorganisms);
e) establish airflow volume flow rate, airflow velocity and pressurization;
f) identify practical issues related to onsite operations, e.g. reliability and control, layout, age,
condition, function, maintenance;
g) determine the results of any benchmarking exercise, which should compare the existing design
with best practice energy use with respect to energy consumption and cost; and
h) establish life cycle costs and optimization studies, if possible.
4.6 Process for design/construction of new build or updating cleanrooms
4.6.1 Review user requirements and project scope
The cleanroom performance criteria to meet the requirements of the process, the products and
personnel comfort should be identified.
NOTE See Clause 5.
4.6.2 Undertake energy performance design review
The design of the cleanroom should be reviewed to ensure that the following energy performance
aspects are considered:
a) the design performance (in classification terms: particle concentration, and other cleanliness
attributes;
b) the results of any benchmarking exercise, which should confirm that the new design satisfies best
practice energy use with respect to energy consumption and cost.
The design review should be specifically focused on energy performance of the cleanroom and the best
estimates of projected energy use. This should cover lighting, air handling, heating, cooling and any
other significant energy use, particularly for small mini environments.
4.7 Comparative review of cleanroom environmental performance
A review should be undertaken to compare the environmental performance of the designed (new)
cleanroom or redesigned (existing) cleanroom with the environmental performance requirements (of
the process, the products and personnel comfort), to avoid overdesigning, e.g. specifying cleanliness
classifications that are lower (cleaner) than necessary or clean spaces that are larger than necessary.
ISO 14644-16:2019(E)
4.8 Identify energy reduction opportunities
The project team should analyse the results of the comparative review, identify potential energy
reduction opportunities and carry out a preliminary selection. This can be done using the checklist
given in Annex B.
Once the preliminary selection has been made the selection should be assessed and documented as
part of the decision-making process, and the reasons why an opportunity is chosen, or not, should be
recorded.
Life cycle cost of energy reduction opportunities should be evaluated and considered in the analysis.
4.9 Assess the impact of energy reduction opportunities
Once the potential energy saving opportunities have been identified (using, for example, the table
in Annex B), a preliminary selection should be carried out. A detailed impact assessment report
should be produced, covering all of the potential opportunities identified and taking into account any
corresponding recommendations given in Annex B, as well as the following business requirements:
— feasibility;
— process compatibility and product quality requirements;
— safety and regulations;
— cost;
— return on investment;
— incentives (e.g. government initiatives);
— implementation timeline/programme;
— implementation resources; and
— business continuity.
4.10 Select energy reduction opportunities for implementation
The energy reduction opportunities identified by the impact assessment report (4.9) as having become
less viable or more challenging should be reprioritized behind those that can be easily and effectively
delivered. A final prioritization and implementation programme should then be prepared.
Specifications and scopes of work should be defined for those opportunities that are to be implemented.
Where industries have standards or guidelines that specify performance requirements, all the
situations where one or more performance requirements are in conflict with a particular proposed
energy reduction measure should be identified.
NOTE Such performance requirements can include air quality (in terms of particle and other cleanliness
attributes), filter efficiency, unidirectional airflow velocity, supply air volume flow rate, recovery time,
temperature, humidity and pressure differentials between adjacent rooms of different grades.
When these situations have been identified, a detailed justification should be prepared to demonstrate
that product quality is not affected by the proposed measure. Agreement should then be obtained from
the client prior to implementation.
4.11 Implementation
A detailed implementation plan should be prepared, and the work undertaken. T
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