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Australian/New Zealand Standard
Cleanrooms and associated controlled environments Part 4: Design, construction and start-up
AS/NZS ISO 14644.4:2002
This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee ME-060, Controlled Environment. It was approved on behalf of the Council of Standards Australia on 31 May 2002 and on behalf of the Council of Standards New Zealand on 23 May 2002. It was published on 10 July 2002.
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The following are represented on Committee ME-060:
Auckland Regional Chamber of Commerce Australian Chamber of Commerce and Industry Australian Contamination Control Society Australian Industry Group Australian Institute of Refrigeration Air Conditioning and Heating Australian Pharmaceutical Manufacturers Association Australian Society of Microbiology CSIRO Australian Animal Health Laboratory Commonwealth Department of Health and Aged Care Medical Industry Association of Australia N.S.W. Health Department National Association of Testing Authorities Society of Hospital Pharmacists of Australia
Keeping Standards up-to-date
Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about joint Australian/New Zealand Standards can be found by visiting the Standards Australia web site at www.standards.com.au or Standards New Zealand web site at www.standards.co.nz and looking up the relevant Standard in the on-line catalogue. Alternatively, both organizations publish an annual printed Catalogue with full details of all current Standards. For more frequent listings or notification of revisions, amendments and withdrawals, Standards Australia and Standards New Zealand offer a number of update options. For information about these services, users should contact their respective national Standards organization. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Please address your comments to the Chief Executive of either Standards Australia International or Standards New Zealand at the address shown on the back cover.
This Standard was issued in draft form for comment as DR 02031.
AS/NZS ISO 14644.4:2002
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Australian/New Zealand Standard
Cleanrooms and associated controlled environments Part 4: Design, construction and start-up
Originated as part of AS 13861976 and AS 13871976.
Previous editions AS 1386.11989, AS 1386.21989, AS 1386.31989 and AS 1386.41989. AS 1386.11989, AS 1386.21989, AS 1386.31989 and AS 1386.41989 jointly revised, amalgamated and redesignated as AS/NZS ISO 14644.4:2002.
COPYRIGHT Standards Australia/Standards New Zealand All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Jointly published by Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001 and Standards New Zealand, Private Bag 2439, Wellington 6020 ISBN 0 7337 4611 X
ii
PREFACE This Standard was prepared by the Joint Australia/New Zealand Committee ME-060, Controlled Environment. This Standard is identical with and has been reproduced from ISO 14644-4:2001, Cleanrooms and associated controlled environments, Part 4: Design, construction and start-up. It is part of a series of Joint Australian/New Zealand Standards that will supersede in part the AS 1386 series titled Cleanrooms and clean workstations. It is expected that a guide will be published to include informative material from the AS 1386 series that is not covered in the adopted ISO series. The objective of this Standard is to specify the requirements for the design and construction of cleanroom facilities.
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As this Standard is reproduced from an International Standard, the following applies:
(a)
Its number appears on the cover and title page while the International Standard number appears only on the cover.
(b)
In the text, this part of ISO 14644 should be read this Australian/New Zealand Standard.
(c)
A full point substitutes for a comma when referring to a decimal marker.
References to international Standards should be replaced by references to the following
Australian/New Zealand Standards.* Reference to International Standards
Australian/New Zealand Standard
ISO
AS/NZS ISO
14644
Cleanrooms and associated
controlled environments
14644
Cleanrooms and associated
controlled environments
14644-1
Part 1: Classification of air
cleanliness
14644.1
Part 1: Classification of air
cleanliness
* Any international Standards not listed do not have an equivalent Australian/New Zealand Standard.
iii
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Terms and definitions ...................................................................................................................................2
Planning and design......................................................................................................................................4
Construction and start-up.............................................................................................................................5
7 7.1 7.2 7.3 7.4
Testing and approval.....................................................................................................................................6
General............................................................................................................................................................6 Construction approval ..................................................................................................................................6 Functional approval.......................................................................................................................................6 Operational approval.....................................................................................................................................6
8 8.1 8.2 8.3 8.4 8.5 8.6 8.7
Documentation...............................................................................................................................................6 General............................................................................................................................................................6 Record of an installation...............................................................................................................................6 Operational instructions ...............................................................................................................................6 Instructions for performance monitoring....................................................................................................7 Maintenance instructions .............................................................................................................................7 Maintenance record .......................................................................................................................................7 Record of operation and maintenance training..........................................................................................8
Annex A (informative) Control and segregation concepts......................................................................................9
Annex B (informative) Classification examples .....................................................................................................16 Annex C (informative) Approval of an installation.................................................................................................19 Annex D (informative) Layout of an installation.....................................................................................................23 Annex E (informative) Construction and materials................................................................................................27 Annex F (informative) Environmental control of cleanrooms ..............................................................................32 Annex G (informative) Control of air cleanliness...................................................................................................35 Annex H (informative) Additional specification of requirements to be agreed upon between purchaser/user and designer/supplier ......................................................................................................37 Bibliography ..............................................................................................................................................................50
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iv
NOTES
1 AUSTRALIAN/NEW ZEALAND STANDARD
Cleanrooms and associated controlled environments
Part 4: Design, construction and start-up
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Scope
This part of ISO 14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance. NOTE Further guidance in respect of the above requirements is given in annexes A to H. Other parts of ISO 14644 may provide complementary information.
Application of this part of ISO 14644 is restricted in the following:
user requirements are represented by purchaser or specifier;
specific processes to be accommodated in the cleanroom installation are not specified;
fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected;
process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;
regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.
Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 14644. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness. ISO 14644-2:2000, Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.
COPYRIGHT
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AS/NZS ISO 14644.4:2002 Cleanrooms and
associated controlled environments - Design, construction and start-up
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