ISO 22519:2023
(Main)Membrane-based generation of water for injection (WFI)
Membrane-based generation of water for injection (WFI)
This document provides a benchmark for evaluation of the design, operation and performance of water for injection (WFI) generation systems based on membranes. This document is applicable to the design of new systems. This document covers the following topics: — principles of membrane-based WFI generation systems; — process design, construction, operation and maintenance of membrane-based WFI generation systems; — controlling membrane-based WFI generation system parameters. This document does not cover the following topics: — validation; — distillation.
Production d'eau pour préparations injectables (EPPI) utilisant des membranes
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INTERNATIONAL ISO
STANDARD 22519
Second edition
2023-04
Membrane-based generation of water
for injection (WFI)
Production d'eau pour préparations injectables (EPPI) utilisant des
membranes
Reference number
ISO 22519:2023(E)
© ISO 2023
---------------------- Page: 1 ----------------------
ISO 22519:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
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ISO 22519:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 2
4 System boundaries .3
5 Feed water. 3
6 Process design for membrane-based WFI generation systems .3
6.1 General . 3
6.2 Design conditions . 4
6.3 Important design factors . . 4
6.4 Examples of possible configurations of water technology stages in WFI generation
systems . 4
6.5 Primary microbial reduction unit operations . 4
6.6 Instrumentation . 5
7 Sanitization . .5
7.1 General . 5
7.2 Sanitization types . 5
8 Construction . 6
9 Demonstrating performance of critical quality attributes . 6
10 Sampling . 6
11 System operation . 7
12 System maintenance .7
13 Control . 7
14 Other considerations . 8
Bibliography . 9
iii
© ISO 2023 – All rights reserved
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ISO 22519:2023(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 282, Water reuse.
This second edition cancels and replaces the first edition (ISO 22519:2019), which has been technically
revised.
The main changes are as follows:
— title changed;
— PW systems removed from the Scope;
— document structure revised.
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.
iv
© ISO 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22519:2023(E)
Introduction
The water quality specifications for water for injection (WFI) are given in national and International
Standards and are well defined and understood.
The WFI generation systems potentially have to be able to cope with fluctuating feed water quality and
be in accordance with the company policy and current good manufacturing practice (cGMP).
Properly engineered, constructed, operated and maintained membrane-based generation systems
can have comparable reliability in meeting WFI quality specifications with low operational costs in
comparison with thermal-based WFI generation. At the time of publication, all major pharmacopoeia
allow non-distillation-based WFI generation, with the exception of the Chinese Pharmacopoeia. The
Chinese Pharmacopoeia has initiated revisions to related standards.
This document has been developed to address the lack of an International Standard concerning
membrane-based WFI generation.
The aim of this document is to:
— set out clear principles needed for reliable membrane-based generation of WFI;
— improve membrane-based generation of WFI process systems and methods;
— combine relevant standards, guidelines and global expert knowledge into one International
Standard;
— consider in-system microbiological aspects of WFI generation;
— standardize expectations for membrane-based WFI generation.
This document provides a global benchmark that can be used by industries that use the WFI generation
system.
v
© ISO 2023 – All rights reserved
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 22519:2023(E)
Membrane-based generation of water for injection (WFI)
1 Scope
This document provides a benchmark for evaluation of the design, operation and performance of water
for injection (WFI) generation systems based on membranes.
This document is applicable to the design of new systems.
This document covers the following topics:
— principles of membrane-based WFI generation systems;
— process design, construction, operation and maintenance of membrane-based WFI generation
systems;
— controlling membrane-based WFI generation system parameters.
This document does not cover the following topics:
— validation;
— distillation.
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 20670, Water reuse — Vocabulary
3 Terms, definitions and abbreviated terms
For the purposes of this document, the terms and definitions given in ISO 20670 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 Terms and definitions
3.1.1
pretreatment
equipment and process stages up to and including the first-pass reverse osmosis (RO) pump or other
membrane-based primary bioburden reduction step
3.1.2
generation system
equipment and process stages after (downstream) reverse osmosis (RO) stage 1 pump
1
© ISO 2023 – All rights reserved
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ISO 22519:2023(E)
3.1.3
multimedia filter
MMF
layered filtration media in a pressurized container, used to reduce the level of suspended solids in
incoming feed water
Note 1 to entry: Me
...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22519
ISO/TC 282 Secretariat: SAC
Voting begins on: Voting terminates on:
2022-03-21 2022-06-13
Membrane based generation of WFI
ICS: 13.060.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 22519:2022(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 2022
---------------------- Page: 1 ----------------------
ISO/DIS 22519:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 22519:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 2
4 System boundaries .3
5 Feed water. 3
6 Process design for membrane based WFI generation system . 3
6.1 Design conditions . 3
6.2 Important design factors . . 4
6.3 Examples of possible configurations of water technology stages in WFI generation
systems . 4
6.4 Primary microbial reduction unit operations . 4
6.5 Instrumentation . 5
7 Sanitization . .5
7.1 General . 5
7.2 Sanitization types . 5
8 Construction . 5
9 Demonstrating critical quality attributes performance. 6
10 Sampling . 6
11 System operation . 6
12 System maintenance .7
13 Control . 7
14 Other considerations . 7
Bibliography . 8
iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/DIS 22519:2022(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 [or Project Committee] ISO/TC 282, Water Reuse.
This second edition cancels and replaces the first edition (ISO 22519:2019), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— title changed to Membrane Based Generation of WFI.
— PW systems were removed from scope.
— table of contents was changed to: System boundaries, feed water, process design for membrane
based WFI generation system, sanitization, construction, demonstrating critical quality attributes ,
sampling, system operation, system maintenance, control, other consideration.
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.
iv
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 22519:2022(E)
Introduction
The water quality specifications for Water for Injection (WFI) are given in national and international
standards and are well defined and understood.
The WFI generation systems may have to be able to cope with fluctuating feed water quality and be in
accordance to the company policy and cGMP.
Properly engineered, constructed, operated and maintained membrane based generation systems
can have comparable reliability in meeting WFI quality specifications with low operational
costs in comparison with thermal based WFI generation. As of the writing of this ISO standard
all major pharmacopeia allow non-distillation based WFI generation with the exception of
the Chinese Pharmacopoeia (ChP).
To meet the lack of an international standard concerning membrane based WFI generation, the ISO
document, 22519 “Membrane Based Generation of WFI” has been formulated.
The aim of the standard is to:
— set out clear principles needed for reliable membrane-based generation of WFI;
— improve membrane-based generation of WFI process systems and methods;
— combine relevant standards, guidelines and global expert knowledge into one international
standard;
— consider in-system microbiological aspects of WFI generation;
— standardize expectations from membrane based WFI generation.
The ISO document provides a global benchmark that can be used by the industries that use WFI
generation system.
v
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 22519:2022(E)
Membrane based generation of WFI
1 Scope
This document provides a benchmark for evaluation of design, operation and performance of WFI
generation systems based on membranes.
This document is relevant for systems, designed after the publication of the ISO 22519, second edition.
This ISO document will cover the following topics:
— principles of membrane-based WFI generation system,
— process design, construction, operation, and maintenance of WFI membrane-based generation
system,
— controlling membrane based WFI generation system parameters.
This ISO document will not cover the following topics:
— validation,
— distillation.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and abbreviated terms
For the purposes of this document, the terms and definitions given in ISO 206
...
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