ISO/FDIS 12370
(Main)Guidelines for treatment and reuse of fermentation-based pharmaceutical wastewater
Guidelines for treatment and reuse of fermentation-based pharmaceutical wastewater
This proposal provides technical guidance for the treatment and reuse of fermentation-based pharmaceutical wastewater. It covers the general requirements for treatment and reuse of fermentation pharmaceutical wastewater, pollution load, process requirements for treatment and reuse of wastewater, recommendation of technology and process, etc. This proposal is applicable to: a) Provide technical reference for project designers of fermentation-based pharmaceutical wastewater treatment; b) Provide standardized guidance for the operation and management of the wastewater treatment and reuse projects in fermentation-based pharmaceutical enterprises. c) Provide guidance for fermentation-based pharmaceutical enterprises to promote technological progress, realise product upgrading, energy conservation and the high-quality development of fermentation-based pharmaceutical wastewater treatment projects. This proposed standard aims to provide guidance for the treatment and reuse technology and process selection of wastewater in fermentation pharmaceutical industry, to promote the development of "zero discharge" of industrial wastewater.
Lignes directrices pour le traitement et la réutilisation des eaux usées pharmaceutiques issues de la fermentation
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FINAL DRAFT
International
Standard
ISO/TC 282/SC 4
Guidelines for treatment and
Secretariat: SAC
reuse of fermentation-based
Voting begins on:
pharmaceutical wastewater
2024-09-24
Voting terminates on:
2024-11-19
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 282/SC 4
Guidelines for treatment and
Secretariat: SAC
reuse of fermentation-based
Voting begins on:
pharmaceutical wastewater
Voting terminates on:
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 SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ii
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 Pollution loading . 2
4.1 Classification of wastewater .2
4.2 Wastewater volume .3
4.3 Quality of produced wastewater .4
5 General principles . 4
6 Wastewater treatment process . 5
6.1 Pretreatment process .5
6.2 Biological treatment process .6
6.2.1 General .6
6.2.2 Hydrolysis acidification reactor .6
6.2.3 UASB reactor .7
6.2.4 Activated sludge process.7
6.2.5 IFAS process .7
7 Reclamation treatment process . 8
7.1 General .8
7.2 Denitrification .8
7.3 Activated carbon adsorption .8
7.4 Coagulation precipitation .8
7.5 Membrane separation .9
7.6 High-efficiency sedimentation tank .9
7.7 Ion exchange .9
7.8 MBR.10
7.9 Fenton oxidation .10
7.10 Ozone catalytic oxidation.10
7.11 Ultraviolet disinfection .10
8 Example processes for wastewater treatment and reclamation .10
Annex A (informative) Pharmaceutical wastewater quality .11
Annex B (informative) Influent quality for membrane separation .13
Annex C (informative) Examples of treatment and reclamation processes for fermentation-
based pharmaceutical wastewater . 14
Bibliography . 17
iii
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, Subcommittee SC 4,
Industrial 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.
iv
Introduction
With the development of the social economy and the improvement of people's living standards, the
public's demand for drugs to improve the quality of life and prolong lifespan is continually increasing.
Pharmaceutical manufacturing ranks among the top five industries in the global economy. Fermentation-
based pharmaceuticals, such as analgesics, anti-inflammatory drugs, antibiotics, lipid regulators, receptor
blockers and X-ray contrast agents, have been widely used in health treatment. At the same time, the impact
of drug pollution and pharmaceutical wastewater discharge has become a global hot topic of concern for
environmental protection. At present, traces of drugs have been detected in sewage wastewater, drinking
water and rivers in many different places, including the United States, China, Australia, Europe and Africa,
and research shows that one of the reasons is the discharge of pharmaceutical wastewater.
Pharmaceutical manufacturing is generally divided into two categories: biopharmaceutical production
and chemical pharmaceutical production. Fermentation-based pharmaceutical production is one kind of
biopharmaceutical production with a long history of development, relatively advanced technology and wide
application. Fermentation-based drugs include antibiotics, vitamins, amino acids and other types of drugs.
The fermentation pharmaceutical production process not only requires a stable supply of pure water, but
also produces a large amount of wastewater. Studies have found that such wastewater usually contains
high levels of waste solvent, refractory organic matter, residual drugs and salt. Meanwhile, for different
production processes, such as bacteria screening, refining and purification, drying, packaging and other
steps, the concentration of pollutants in organic wastewaters varies greatly. The chemical oxygen demand
(COD ) can reach 4 410 mg/l to 40 000 mg/l.
Cr
The rapid development of the fermentation-based pharmaceutical production industry also poses challenges
to the treatment and discharge of wastewater, as well as the management of water resources. If wastewater
is released into the environment without effective treatment, pharmaceutical pollutants
...
DRAFT INTERNATIONAL STANDARD
ISO/DISFDIS 12370:2024(E)
ISO/TC 282/SC 04 4
Secretariat: SAC
Date: 2024-07-1609-10
Guidelines for treatment and reuse of fermentation-based
pharmaceutical wastewater
FDIS stage
ISO/DISFDIS 12370:2024(Een)
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
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
ii
ISO/DISFDIS 12370:2024(Een)
iii
ISO/DISFDIS 12370:2024(Een)
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 documentdocuments 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, Subcommittee SC 4, Industrial
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.
iv © ISO 2023 – All rights reserved
iv
ISO/DISFDIS 12370:2024(Een)
Introduction
With the development of the social economy and the improvement of people's living standards, in order the
public's demand for drugs to improve the quality of life and prolong lifespan , the public's demand for drugs
is continually increasing. The pharmaceuticalPharmaceutical manufacturing ranks among the top five
industries in the global economy. Fermentation-based pharmaceuticals, such as analgesics, anti-inflammatory
drugs, antibiotics, lipid regulators, receptor blockers and X-ray contrast agents, have been widely used in
health treatment. At the same time, the impact of drug pollution and pharmaceutical wastewater discharge
has become a global hot topic of concern for environmental concern and protection. At present, traces of drugs
have been detected in sewage wastewater, drinking water and rivers in many different places, including the
United States, China, Australia, Europe and Africa, and research shows that one of the reasons is the discharge
of pharmaceutical wastewater.
Pharmaceutical manufacturing is generally divided into two categories: biopharmaceutical production and
chemical pharmaceutical production. Fermentation-based pharmaceutical production is one kind of
biopharmaceutical production with a long history of development, relatively advanced technology and wide
application. Fermentation-based drugs include antibiotics, vitamins, amino acids and other types of drugs. The
fermentation pharmaceutical production process not only requires a stable supply of pure water, but also
produces a large amount of wastewater. Studies have found that such wastewater usually contains a high
levellevels of waste solvent, refractory organic matter, residual drugs and salt. Meanwhile, for different
production processes, such as bacteria screening, refining and purification, drying, packaging and other steps,
the concentration of pollutants in organic wastewaters varies greatly. The chemical oxygen demand (COD )
Cr
can reach 4 410 mg/l to 40 000 mg/l.
The rapid development of the fermentation-based pharmaceutical production industry also poses challenges
to the treatment and discharge of wastewater, as well as the management of water resources. If wastewater
is released into the environment without effective treatment, pharmaceutical pollutants will cause water-
quality risks, thus adversely affecting the aquatic ecosystem and public health. In recent years, many countries
have put forward new requirements for the reclamation treatment of industrial wastewater and introduced
many laws and regulations on the reuse of the treated wastewater, requiring that the treated wastewater
shallto be reused in various applications, such as in-plant production, greening and irrigation. However, there
is still a lack of reasonable technical specifications for the reclamation treatment and reuse of fermentation
pharmaceutical industry wastewater in terms of how to select the most suitable treatment technology for each
type of wastewater and how to efficiently recycle or reuse the wastewater.
This document is intended to help solve the current technical problems regarding the treatment and reuse of
fermentation-based pharmaceutical wastewater. In view of the particularity of the production processes
generating fermentation-based pharmaceutical wastewater, this document puts forward the general
recommendations of the process flow and technology selection for reuse of wastewater after treatment under
different pollution loads. At the same time, according to the different reuse scenarios of treated wastewater,
different reuse water treatment technologies are recommended to meet the reuse requirements in each
scenario. This document can provide theoretical support and technical guidance for the treatment and reuse
of fermentation-based pharmaceutical wastewater. At the same time, it willcan be conducive to promoting
technology advancement, product upgrading, energy conservation and emission reduction of fermentation-
based pharmaceutical enterprises. Moreover, it can promote the standardized and the high-quality
development of fermentation-based pharmaceutical wastewater treatment and reuse projects, improve water
efficiency and thus promote the whole industry to develop in a greenmore sustainable and high-quality
directiondevelopment of the whole industry.
v
DRAFT INTERNATIONAL STANDARD ISO/DIS 12370:2024(E)
Guidelines for treatment and reuse of fermentation-based
pharmaceutical wastewater
1 Scope
This document provides technical guidance for fermentation-based pharmaceutical wastewater treatment
and reclamation for different reuse purposes.
This document contains information on pollution loading, general principles and applicable wastewater
treatment and reclamation treatment. In addition, example processes for wastewater treatment and
reclamation are listed to support different treatment conditions and reuse purposes.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 20670:2023, Water reuse — Vocabulary.
3 Terms, definitions and abbreviated terms
For the purposes of this document, the following terms and definitions given in ISO 20670:2023 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
denitrification
reduction of nitrate and nitrite to the end product nitrogen (in the form of the gas) by the action of bacteria
[SOURCE: ISO 11733:2004, 3.6]
3.1.2
fermentation-based pharmaceutical wastewater
process and non-process wastewater generated in the production operations of fermentation pharmaceutical
enterprises
Note 1 to entry: Process wastewater refers to the in-situ residual mother liquor and wastewater produced in the process
of fermentation-based pharmaceutical production (3.1.3.). Non-process wastewater refers to wastewater produced by
cooling or cleaning equipment and from washing ground surfaces.
ISO/DISFDIS 12370:2024(Een)
3.1.3
fermentation-based pharmaceutical production
process of producing antibiotics or other active pharmaceutical ingredients by fermentation and producing
drugs through separation, purification, refining and other processes
Note 1 to entry: The types of drugs can be divided into antibiotics, vitamins, amino acids and other categories.
3.1.4
hydraulic retention time
theoretical average period of time that influent wastewater remains in the biological reactor
Note 1 to entry: The hydraulic retention time (HRT) is calculated as net biological reactor volume (m ) divided by the
daily influent wastewater flow (m /d).
3.1.5
kettle liquid
liquid left at the bottom after distillation in a distillation column
3.1.6
basic on-site domestic wastewater
water that contains only human body waste and human liquid waste, and can contain grey water from
washing, but does not contain commercial or industrial discharges
[SOURCE: ISO 24513:2019, 3.2.2.2.1]
3.2 Abbreviated terms
B/C ratio ratio of BOD /COD
5 Cr
BOD five-day biochemical oxygen demand
COD chemical oxygen demand by dichromate method
Cr
IFAS integrated fixed-film activated sludge
MBR membrane bioreactor
MLSS mixed liquor suspended solids
MLVSS mixed liquor volatile suspended solids
NH -N
ammonia-nitrogennitrate-nitrogen
NO -N
NO -N nitrate-nitrogen
NTU nephelometric turbidity unit
SS suspended solids
TN total nitrogen
TP total phosphorus
UASB upflow anaerobic sludge blanket
2 © ISO 2023 – All rights reserved
ISO/DISFDIS 12370:2024(Een)
4 Pollution loading
4.1 Classification of wastewater
The typical process configuration for fermentation-based pharmaceutical production and the main
wastewater generation links are shown in Figure 1Figure 1.
Figure 1 — Typical processes and wastewater generation links for fermentation-based
pharmaceutical production
Classification of fermentationFermentation-based pharmaceutical wastewater is classified as follows:
a) a) Process wastewater: residual mother liquor and wastewater generated in the process of fermentation-
based pharmaceutical production, such as extraction residual mother liquor, refining residual mother
liquor or resin regeneration wastewater.
b) b) Non-process wastewater: production flushing drainage (e.g. equipment flushing water, ground
flushing water), dynamic system drainage (e.g. drainage from recirculating cooling water system and
cooling water during process), etc.
4.2 Wastewater volume
Measured data should be used for quantifying the amount of wastewater generated in the fermentation-based
pharmaceutical production process. The total amount of wastewater discharge should be measured and
determined at the point of final discharge from the factory, and the process wastewater discharged from each
production process should be measured individually.
When there is no actual measurement data available, analogous survey data can be used. The amount of
wastewater can be determined by analogy with the emission data of existing fermentation pharmaceutical
enterprises with the same production scale, similar raw materials and products and similar production
processes. Annex AAnnex A provides further information about pharmaceutical wastewater quality. See
Table A.1Table A.1 for representative generation of wastewater from fermentation-based pharmaceutical
production.
If there is no measured or analogous data, this can be estimated according to Formulae (1)using Formulae (1)
and (2)(2)::
𝑄𝑄 =∑𝑄𝑄 (1)
y i
𝑄𝑄 =𝛼𝛼⋅𝛽𝛽⋅𝑄𝑄+𝑇𝑇 (2)
i i
ISO/DISFDIS 12370:2024(Een)
where
Q is the total wastewater production (m /d);
y
Q is the wastewater generation rate of each production process (m /d);
i
α is the reduction factor for generated wastewater calculated according to the water supply, which is
determined according to factors such as the production process of the enterprise and the level of
water supply and drainage facilities, generally taking 70 % to 90 %;
β is the percentage of sub-item water supply for process water that can be determined according to
actual material accounting;
Q is the production water consumption (m /d), which can be determined according to production
water quota;
T is the amount o
...
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