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ISO 22519:2019 (E)
ISO - Cover page
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
 3.1 Terms and definitions
 3.2 Abbreviated terms
4 Design and practices
 4.1 Setting system boundaries
 4.2 General system requirements
 4.3 User Requirements Specifications (URS) scope
 4.4 Detailed system capacity calculation
5 Selecting materials, methods and system components
 5.1 Recommended system components/treatment stages
 5.2 Advantages and disadvantages of system components/treatment stages
 5.3 Materials of construction — General
 5.4 Stainless steel (SS) piping — General
 5.5 Non-final product water piping/tubing in the PW/WFI pretreatment and production
 5.6 Piping/tubing in contact with PW/WFI product
6 Sampling
 6.1 Sampling principles
 6.2 Minimum sampling point and locations
 6.3 Sampling conductivity
7 Instruments
 7.1 Minimum instrumentation for installation
 7.2 Parameters for measuring, alarming, storing and graphing from online instruments
8 System design
 8.1 Specification of feed water
 8.2 System selection table based on feed water quality
9 Operation
 9.1 Production
 9.2 Recirculation when storage tank full
 9.3 Sanitization
 9.4 Chlorine and chlorination
10 Maintenance
 10.1 Standard Operating Procedure (SOP´s)
 10.2 Filter replacement
 10.3 Chlorine instrumentation
 10.4 Carbon dioxide
 10.5 Membrane Integrity for polishing UF
11 Specific Good Manufacturing Practice (GMP) requirements
 11.1 General
 11.2 Safety considerations
 11.3 Commissioning and qualification requirements
12 Control philosophy
 12.1 Minimum control loops needed for installation
 12.2 Automation
13 Alarms
 13.1 Required alarms
 13.2 Recommended alarms
14 Recommended engineering documentation
 14.1 General user guide
 14.2 Instrumentation documentation
 14.3 General piping/tubing
 14.4 PW/WFI product piping/tubing
 14.5 Tanks
 14.6 Pumps
 14.7 Insulation
 14.8 Signs
 14.9 Software
 14.10 Electrical documentation
 14.11 Factory acceptance test (FAT) protocol
 14.12 IQ/OQ protocol
 14.13 Spare parts list
Annex A (informative) Examples of PW production systems
Annex B (informative) Examples of feed water categories
Annex C (informative) System selection table
Annex D (informative) Configuration of typical integrity test for polishing UF
Bibliography

INTERNATIONAL

STANDARD

ISO
22519
First edition
2019-06



Purified water and water for injection pretreatment and production systems
Systèmes de prétraitement et de production d'eau purifiée et d'eau d'injection



Contents Page
Foreword
Introduction
Scope
Normative references
Terms, definitions and abbreviated terms
Terms and definitions
Abbreviated terms
Design and practices
Setting system boundaries
General system requirements
User Requirements Specifications (URS) scope
Detailed system capacity calculation
Selecting materials, methods and system components
Recommended system components/treatment stages
Advantages and disadvantages of system components/treatment stages
Materials of construction — General
Stainless steel (SS) piping — General
Non-final product water piping/tubing in the PW/WFI pretreatment and production
Piping/tubing in contact with PW/WFI product
Sampling
Sampling principles
Minimum sampling point and locations
Sampling conductivity
Instruments
Minimum instrumentation for installation
Parameters for measuring, alarming, storing and graphing from online instruments
System design
Specification of feed water
System selection table based on feed water quality
Operation
Production
Recirculation when storage tank full
Sanitization
Chlorine and chlorination
Maintenance
Standard Operating Procedure (SOP´s)
Filter replacement
Chlorine instrumentation
Carbon dioxide
Membrane Integrity for polishing UF
Specific Good Manufacturing Practice (GMP) requirements
General
Safety considerations
Commissioning and qualification requirements
Control philosophy
Minimum control loops needed for installation
Automation
Alarms
Required alarms
Recommended alarms
Recommended engineering documentation
General user guide
Instrumentation documentation
General piping/tubing
PW/WFI product piping/tubing
Tanks
Pumps
Insulation
Signs
Software
Electrical documentation
Factory acceptance test (FAT) protocol
IQ/OQ protocol
Spare parts list
Examples of PW production systems
Examples of feed water categories
System selection table
Configuration of typical integrity test for polishing UF
Bibliography

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.
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.

Introduction

A large variety of water systems exists today in the Biopharma market; often these water systems are of differing levels of efficiency and have different maintenance needs. Water quality for Purified Water (PW) and Water for Injection (WFI) is specified in national and international standards, but a standardized system for producing PW and WFI is not in place.
This document provides a standard benchmark that can be used by the industries that use PW and/or WFI, national governments, state authorities and regulatory bodies to evaluate PW/WFI systems.
This document
allows users to specify water systems that fit specific needs without being experts in the water system field;
allows users to decide whether the offered systems are safe, efficient and sustainable;
enables national governments, state authorities and regulatory bodies to perform professional audits;
provides auditors a standard check list to harmonize equipment and systems in the water industry;
sets a high benchmark for suppliers of water systems all over the world, to be used as a point of reference for their systems and;
will improve reliability of the water generation process methods and water product while reducing downtime needed for scheduled and non-scheduled maintenance.
This document also defines technical terms related to PW and WFI generation.
See Annex A, "examples of PW production systems".
See Annex B, "examples of feed water categories".
See Annex C, "system selection table".
See Annex D, "configuration of typical integrity test for polishing UF".
INTERNATIONAL STANDARD ISO 22519:2019 (E)
Purified water and water for injection pretreatment and production systems

1 Scope

This document specifies design, materials selection, construction and operation of Purified Water (PW) and Water for Injection (WFI) pretreatment and membrane-based production systems.
As many different types of feed water are possible, different components and configurations are presented. A decision matrix is provided to give guidance for the different types of feed water.
This document excludes
selection of the appropriate compendial water definition per system: e.g. PW, WFI or other;
thermal process for generation of PW/WFI;
loops, storage and distribution;
pure steam generation and distribution;
laboratory water systems and
validation.

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 following terms and definitions given in ISO 20670 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 Terms and definitions

3.1.1
pretreatment
equipment and process stages before (upstream) high pressure RO pump
3.1.2
production system
equipment and process stages after (downstream) high pressure RO pump
Note 1 to entry: If there is a tank, before the high pressure RO pump, then the tank can be included in the production system.
3.1.3
pretreatment ultra filtration
pretreatment UF
membrane based process for removal of suspended solids, bacteria and TOC upstream of RO
Note 1 to entry: Usually operated with a reject stream and cleaned with a back wash.
3.1.4
MMF
multi media filter
layered filtration media in a pressurized container, used to reduce the level of suspended solids (turbidity) in incoming feed water
Note 1 to entry: Media layers can consist of anthracite, sand and garnet.
3.1.5
flushed screen/disc filter
FS/DF
filter based on a static screen with a water flush of the cake that builds up on the screen
3.1.6
chlorination
dosage/generation of Hypochlorite/Chlorine to generate controlled free chlorine levels in the system
3.1.7
softener
pressurized container of softening resin for replacement of hardness ions, calcium, magnesium, barium and strontium, with the sodium ion
3.1.8
antiscalant
AS
chemical scale inhibitor or sequestering agent that minimize the potential for scale precipitation on the reject surface of a RO membrane
3.1.9
electric scale control
ESC
electrolytic scale inhibitor that minimizes the potential for scale precipitation on the reject surface of a RO membrane
3.1.10
activated carbon filter
ACF
granular activated carbon (GAC) pressurized container of activated carbon media for removal of free chlorine, chloramines and Total Organic Carbon (TOC)
3.1.11
degassing CO2 contact membrane
degasser
microporous hollow fiber membrane that brings into direct contact a liquid and strip gas and/or vacuum
Note 1 to entry: The dissolved gas in the liquid will pass though the membrane and into the strip gas and/or vacuum on the other side of the membrane.
3.1.12
ultra violet (UV) lamp
irradiation of water with UV light in wavelengths ranging from 180 nm to 350 nm
3.1.13
microfiltration
MF
pressure driven separation process designed to remove particles and macromolecules. MF is usually installed as part of the pre-treatment for other downstream process
Note 1 to entry: The nominal filtration sizes are 0,05 micron to 2 micron.
3.1.14
single pass reverse osmosis
SPRO
single pass membrane based process to separate dissolved ions and suspended solids
3.1.15
double pass reverse osmosis
DPRO
double pass membrane-based process to separate dissolved ions and suspended solids
3.1.16
continuous electro de-ionization
CDI/EDI/CEDI
process for ion removal from water utilizing: electricity, ion exchange membranes and resin
3.1.17
polishing ultra filtration
polishing UF
membrane based process using molecular weight cut off 6 000 or smaller for reduction of endotoxin, TOC and bacteria post RO or post CDI/EDI/CEDI
3.1.18
anion and cation de-ionizers
separate pressurized containers of anion ion exchange resin and cation ion exchange resin, for removal of both cations and anions
Note 1 to entry: Resins are regenerated on site or off site.
3.1.19
single use mixed bed polisher
pressurized containers of mixed anion and cation ion exchange resin for removal of both cations and anions
Note 1 to entry: Resins are regenerated off site.

3.2 Abbreviated terms

ACF activated carbon filter
AS antiscalant
BW butt welding
CD chlorine dioxide
CFU colony forming units
CIP cleaning in place
CIT conductivity indicator and transmitter
CLIT chlorine indicator and transmitter
DPRO double pass RO
EP European Pharmacopeia
EPDM ethylene propylene diene monomer
ESC electric scale control
FAT factory acceptance test
FIT flow indicator and transmitter
FRP/PE fibre reinforced plastic (on) polyethylene
FS/DF filter screen/disk filter
GAC granular activated carbon
GMP good manufacturing practice
HOD hydro optical dechlorination
HP high pressure
HSDS Human Services Data Specification
HWS hot water sanitization
ID inside diameter
IQ Installation Qualification
ISPE International Society for Pharmaceutical Engineering
JP Japanese Pharmacopeia
L/D ratio between piping/tubing length/diameter
LT level transmitter
MF microfiltration
MMF multimedia filter
MP mechanical polish
NA non applicable
NaOH sodium hydroxide
NFPA National Fire Protection Association
NR not recommended
OSHA Occupational Safety and Health Administration
ORP oxidation reduction potential
OQ Operational Qualification
P possible
PEEK polyether ether ketone
PFA perfluoralkoxy alkanes
PI pressure indicator
PIT pressure indicator and transmitter
POU point of use
PPP PW/WFI pretreatment and production
PQ Performance Qualification
PS pure steam
PTFE polytetrafluoroethylene
PVC polyvinyl chloride
PW Purified Water
QIT quantity indicator and transmitter
R recommended
RO reverse osmosis
SBS sodium bi sulfite
S&D Storage and Distribution
SOP standard operating procedure
SPRO single pass reverse osmosis (RO)
SS stainless steel
TC Tri Clamp
TDS total dissolved solids
TIG/GTAW Tungsten Inert Gas/Gas Tungsten Arc Welding
TT temperature indicator
TOC total organic carbon
UF ultrafiltration
URS User Requirements Specifications
USP US Pharmacopeia
WFI Water for Injection
Bibliography
[1]
Pharmaceutical Engineering Guide ISPE Volume 4: Water and Steam Systems, December 2011
[2]
ASME BPE-2014 Bioprocessing Equipment, October 2014
[3]
European Pharmacopoeia 9th edition, January 2017
[4]
The Japanese Pharmacopoeia 17th edition, March 2016
[5]
US Pharmacopeia Convention USP 39, May 2017
[6]
FDA CFR 21 (food and drugs) part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, April 2017
[7]
Volume 4, GMP, Mechanical Products for Human and Veterinary Use Annex 11: Computerised System, January 2011)
[8]
ASTM D 6908-03 Standard Practice for Integrity Testing of Water Filtration Membrane Systems
[9]
ISPE-Handbuch, Herstellung von Wasser für Injektionszwecke ohne Destillationsverfahren, 1. Auflage 2019



ICS 13.060.01
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