ISO 22519

Membrane-based generation of water for injection (WFI)

Production d'eau pour préparations injectables (EPPI) utilisant des membranes

General Information

• Status: Published
• ICS: 13.060.01 - Water quality in general
• Technical Committee: ISO/TC 282 - Water reuse
• Drafting Committee: ISO/TC 282/WG 3 - Water systems for biopharma industries
• Current Stage: 6000 - International Standard under publication
• Completion Date: 23-Feb-2023

Relations

• Revises: ISO 22519:2019 - Purified water and water for injection pretreatment and production systems
• Effective Date: 23-Apr-2020

Standards Content (Sample)

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
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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
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ISO/DIS 22519:2022(E)
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© ISO 2022

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© ISO 2022 – All rights reserved
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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
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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.
© ISO 2022 – All rights reserved
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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.
© ISO 2022 – All rights reserved
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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
...