ISO 12370:2025
(Main)Guidelines for treatment and reuse of fermentation-based pharmaceutical wastewater
Guidelines for treatment and reuse of fermentation-based pharmaceutical wastewater
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.
Lignes directrices pour le traitement et la réutilisation des eaux usées pharmaceutiques issues de la fermentation
General Information
Standards Content (Sample)
International
Standard
ISO 12370
First edition
Guidelines for treatment and
2025-01
reuse of fermentation-based
pharmaceutical wastewater
Lignes directrices pour le traitement et la réutilisation des eaux
usées pharmaceutiques issues de la fermentation
Reference number
© ISO 2025
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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 processes . 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 processes . 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
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This document was prepared by Technical Committee ISO/TC 282, Water reuse, Subcommittee SC 4,
Industrial water reuse.
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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.
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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 treated wastewater
to 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
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