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HJ 1062-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry -- Biological pharmaceutical products manufacturing
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Technical specification for application and issuance of pollutant permit Pharmacy industry -- Biological pharmaceutical products manufacturing
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HJ 1062-2019
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Standard similar to HJ 1062-2019 HJ 1060 HJ 1061 HJ 1059 Basic data | Standard ID | HJ 1062-2019 (HJ1062-2019) | | Description (Translated English) | Technical specification for application and issuance of pollutant permit Pharmacy industry -- Biological pharmaceutical products manufacturing | | Sector / Industry | Environmental Protection Industry Standard | | Word Count Estimation | 53,523 | | Date of Issue | 2019-12-10 | | Date of Implementation | 2019-12-10 | | Issuing agency(ies) | Ministry of Ecology and Environment | HJ 1062-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry -- Biological pharmaceutical products manufacturing
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Sewage Permit Application and Issuance Technical Specifications Pharmaceutical Industry-Manufacture of Biopharmaceutical Products)
National Environmental Protection Standard of the People's Republic of China
Technical Specifications for Sewage Permit Application and Issuance
Pharmaceutical Industry-Biopharmaceutical Product Manufacturing
Technical specification for application and issuance of pollutant permit
Pharmacy industry-Biological pharmaceutical products manufacturing
2019-12-10 Release
2019-12-10 Implementation
Released by the Ministry of Ecology and Environment
Contents
Foreword ...
1 Scope ... 1
2 Normative references ... 1
3 Terms and definitions ... 2
4 Reporting requirements for basic information of sewage units ... 3
5 Method for determining the corresponding discharge port and permitted emission limit in the production and discharge link ... 12
6 Possible technical requirements for pollution prevention ... 16
7 Management requirements for self-monitoring ... 17
8 Requirements for Compiling Environmental Management Ledger and Pollutant Discharge Permit Report ... 21
9 Accounting method for actual emissions ... 24
10 Compliance Determination Method ... 27
Appendix A (Informative) Product Names of Biopharmaceutical Products ... 29
Appendix B (Informative) Reference Table of Pollution Prevention Techniques ... 34
Appendix C (Informative) Reference Table for Environmental Management Ledger Records ... 36
Appendix D (Informative) Reference Table for Sewage Permit Implementation Report ... 40
Foreword
In order to implement the "Environmental Protection Law of the People's Republic of China"
Water Pollution Control Law, Soil Pollution Control Law of the People's Republic of China, and other laws and regulations;
Notice on the Implementation Plan of the Emission Permit System (Guobanfa [2016] No. 81) and the Measures for the Administration of Emission Permits (Trial) (Environmental Protection
(Ministry Decree No. 48), improve the technical support system for sewage permits, guide and standardize the pharmaceutical industry-biological product manufacturing sewage discharge units sewage permits
Application for certification and issuance of this standard.
This standard specifies the basic requirements for reporting and issuing the pollution permit application for the pharmaceutical industry-biopharmaceutical manufacturing sewage discharge unit,
Determination of permitted emission limits, methods of actual emissions accounting and compliance determination, as well as self-monitoring, environmental management ledger and pollution permit enforcement
Environmental management requirements, such as bank reports, put forward feasible technical requirements for pharmaceutical industry-biological drug product manufacturing pollution prevention.
Appendices A to D of this standard are informative appendices.
This standard is issued for the first time.
This standard was formulated by the Department of Environmental Impact Assessment and Emission Management, and the Regulations and Standards Department of the Ministry of Ecology and Environment.
The main drafters of this standard. Hebei University of Science and Technology, Beijing Academy of Environmental Protection Sciences, Environmental Engineering Assessment Center of the Ministry of Ecology and Environment,
Hebei Huayao Environmental Protection Research Institute Co., Ltd., Henglian HNA (Beijing) Management Consulting Co., Ltd., China Chemical Pharmaceutical Industry Association, He
Northern Society for Environmental Science.
This standard was approved by the Ministry of Ecology and Environment on December 10,.2019.
This standard will be implemented as of December 10,.2019
This standard is explained by the Ministry of Ecology and Environment.
Technical Specifications for Sewage Permit Application and Issuance
Pharmaceutical Industry-Biopharmaceutical Product Manufacturing
1 Scope
This standard specifies the basic requirements for reporting and issuing the pollution permit application for the pharmaceutical industry-biopharmaceutical manufacturing sewage discharge unit,
Determination of permitted emission limits, methods of actual emissions accounting and compliance determination, as well as self-monitoring, environmental management ledger and pollution permit enforcement
Environmental management requirements, such as bank reports, put forward feasible technical requirements for pollution prevention.
This standard is applicable to guide the pharmaceutical industry-biopharmaceutical product manufacturing and discharge units in the national sewage permit management information platform (hereinafter abbreviated
(Referred to as the sewage permit platform) to fill in relevant application information, which is applicable to guide the issuing authority to review and determine the permit requirements for sewage units' sewage permits.
This standard applies to the use of biotechnology to produce biochemical drugs, genetically engineered drugs and vaccines, etc.
Drainage permit management of pollutants and water pollutants. Pollution discharge permits for air pollutants and water pollutants discharged by veterinary biopharmaceutical manufacturing units
Management also applies to this standard.
Pharmaceutical industry-Biopharmaceutical product manufacturing and sewage disposal units that implement the "Air Power Pollutant Emission Standards for Thermal Power Plants" (GB 13223)
Production facilities and discharge outlets are applicable to the “Technical Specifications for the Application and Verification of Pollutant Discharge Permits in the Thermal Power Industry”;
Standard (GB 13271) production facilities and discharge outlets are applicable to the "Boiler for the Application of Pollutant Discharge Permit and Technical Specifications" (HJ 953).
Other pollution-producing facilities and waste-discharging facilities that discharge industrial waste water, waste gas, or toxic and hazardous pollutants specified by the state
The release shall be implemented in accordance with the General Rules for the Application and Issuance of Sewage Permits (HJ 942).
2 Normative references
The content of this standard refers to the following documents or clauses therein. For undated references, the valid version applies to this standard
quasi.
GB 8978 Integrated Wastewater Discharge Standard
GB 13223 Air Pollutant Emission Standard for Thermal Power Plants
GB 13271 Boiler Air Pollutant Emission Standard
GB 14554 Emission Standard for Odor Pollutants
GB 15562.2 Environmental Protection Graphical Signs-Solid Waste Storage (Disposal) Site
GB 18597 Pollution Control Standard for Hazardous Waste Storage
GB 21907 Water Pollutant Discharge Standard for Bioengineering Pharmaceutical Industry
GB 37823 Air Pollutant Emission Standards for the Pharmaceutical Industry
GB/T 16157 Determination of particulate matter and sampling of gaseous pollutants in exhaust from stationary pollution sources
HJ 75 Technical Specifications for Continuous Monitoring of Flue Gas (SO2, NOX, Particulate Matter) Emissions from Stationary Pollution Sources
HJ 76 Technical requirements and detection methods of continuous monitoring system for the emission of flue gas (SO2, NOX, particulate matter) from stationary pollution sources
HJ 493 Technical regulations for the storage and management of water samples
HJ 494 Water Quality Sampling Technical Guide
HJ 495 Water Quality Sampling Scheme Design Technical Regulations
HJ 521 Wastewater Discharge Law Code (Trial)
HJ 608 Sewage unit coding rules
HJ 819 Technical Guidelines for Self-monitoring of Sewage Units
HJ 942 General Rules for Application and Issuance of Sewage Permits
HJ 944 General Regulations on Technical Specifications for Environmental Management Ledgers and Pollutant Permits of Pollutant Discharge Units
HJ 953 Application for Sewage Permit and Issuance of Technical Specifications
HJ 2025 Technical Specification for Collection, Storage and Transportation of Hazardous Waste
HJ/T 55 Technical guidelines for fugitive emissions monitoring of air pollutants
HJ/T 91 Technical specifications for surface water and sewage monitoring
HJ/T 194 Technical Specifications for Manual Monitoring of Ambient Air Quality
HJ/T 212 Data Transmission Standard for Online Automatic Monitoring (Monitoring) System of Pollution Sources
HJ/T 353 Technical Specifications for Installation of Water Pollution Source Online Monitoring System (Trial)
HJ/T 354 Technical Specification for Acceptance of Water Pollution Source Online Monitoring System (Trial)
HJ/T 355 Water pollution source online monitoring system operation and assessment technical specifications (trial)
HJ/T 356 Technical Specification for Judging Data Validity of Water Pollution Source Online Monitoring System (Trial)
HJ/T 373 Technical Specifications for Monitoring Quality Assurance and Quality Control of Fixed Pollution Sources (Trial)
HJ/T 397 Fixed source exhaust gas monitoring technical specifications
Catalogue of Classified Management of Pollutant Discharge Permits for Fixed Pollution Sources
"Technical Requirements for the Standardization of Sewage Outfalls (Trial)" (SEPA [1996] No. 470)
"Administrative Measures for the Operation of Automatic Monitoring Facilities for Pollution Sources" (Huanfa [2008] No. 6)
"Announcement on the Time for Implementing the Special Emission Limits of Water Pollutants for the National Discharge Standards in the Taihu Basin"
28th of the year)
Announcement on the Scope of Administrative Regions for the Implementation of National Pollutant Discharge Standards for Water Pollutants in Taihu Basin
(Announcement No. 30 of.2008)
"Policy Policy for the Prevention and Control of Pollution in the Pharmaceutical Industry" (Announcement No. 18,.2012 of the Ministry of Environmental Protection)
Announcement on the Implementation of Special Emission Limits of Air Pollutants (Ministry of Environmental Protection Announcement.2013 No. 14)
National Hazardous Waste List (Order of the Ministry of Environmental Protection No. 39)
"Reply Letter on Issues Concerning the Implementation of Special Emission Limits of Air Pollutants" (Environment Office Atmospheric Letter [2016] No. 1087)
Announcement on Beijing, Tianjin and Hebei air pollution transmission channels to implement special emission limits for air pollutants (Announcement of the Ministry of Environmental Protection
(No. 9 of.2018)
3 terms and definitions
The following terms and definitions apply to this standard.
3.1
Biological pharmaceutical products manufacturing pollutant
emission unit
Refers to the use of microorganisms, parasites, animal toxins, biological tissues, etc., using modern biotechnology methods (mainly genetic engineering technology, etc.)
The process of producing peptides, protein drugs, and vaccines for therapeutic and diagnostic purposes, including genetically engineered drugs,
Sewage discharge unit for pharmaceutical manufacturing and biopharmaceutical research and development due to engineering vaccines and cloning engineering.
3.2
Permitted emission limits
Refers to the maximum discharge concentration (or rate) and amount of pollutants allowed by the pollutant discharge unit as specified in the pollutant discharge permit.
3.3
Special periods
Refers to the pollution discharge unit's pollution according to the environmental quality deadline compliance plan formulated by the local people's government and other relevant environmental management regulations.
Periods with special requirements for the discharge of dyes, including the period of response to severely polluted weather and the period of winter defense.
3.4
Volatile organic compounds (VOCs)
Refers to organic compounds that participate in atmospheric photochemical reactions, or organic compounds determined in accordance with relevant regulations.
When characterizing the overall emissions of VOCs, according to industry characteristics and environmental management requirements, total volatile organic compounds (as TVOC
(Represented), non-methane total hydrocarbons (represented by NMHC) as pollutant control projects.
4 Reporting requirements for basic information of sewage units
4.1 Basic principles
Pharmaceutical industry-Biopharmaceutical product manufacturing and discharge units shall, in accordance with the requirements of this standard, fill in the corresponding information on the sewage permit platform. Sewage permit
However, if the platform does not include the local ecological environment authority that requires reporting or the polluting unit thinks it is necessary to fill in the report, it may add content by itself.
Local eco-environmental authorities at or above the city level with districts may increase the need to include
The content of the information is added to the management system of the pollution permit management information platform declaration system.
Content "column.
4.2 Basic information of pollutant discharge units
The basic information of the polluting unit should be filled in with the name of the unit, whether it needs to be rectified, the type of pollution permit management, postal code, and industry category (fill in
At the time of the report, select "Pharmaceutical Industry-Biopharmaceutical Product Manufacturing-Biopharmaceutical Product" and "Pharmaceutical Industry-Biopharmaceutical Product Manufacturing-Basic
For engineering products and vaccine manufacturing "," Pharmaceutical industry-veterinary drug manufacturing-biopharmaceutical products "," Pharmaceutical industry-veterinary drug manufacturing
-Genetic engineering products and vaccine manufacturing "), whether it is put into production, the date of production, the longitude and latitude of the center of the production and operation site, and whether the location is in
Environmentally sensitive areas (such as key atmospheric control areas, total nitrogen and total phosphorus control areas, etc.), whether they are located in industrial parks, the names of their industrial parks, construction
Document Environmental Impact Assessment Document Examination and Approval Opinion Document Number (Recording Number), Local Government's Identification or Record Document Number of Violating Projects, Main
Document number of total pollutants distribution plan, total particulate matter (t/a), total sulfur dioxide (t/a), total nitrogen oxides
(T/a), total volatile organic compounds (t/a), total chemical oxygen demand (t/a), total ammonia nitrogen (t/a),
Other pollutant total indicators (if any).
4.3 Major Products and Capacity
4.3.1 General principles
The main production unit name, main process name, production facility name, production facility number, facility parameters, product name,
Production capacity, measurement unit, design annual production time and others. The following "4.3.2 ~ 4.3.7" are required and "4.3.8" are optional.
4.3.2 Names of main production units, main processes and production facilities
Refer to Table 1 for the contents of the main production units, main processes, and production facilities of the pollutant discharge unit. Pollutant discharge units need to fill
For the production unit, production process and production facility, you can select “Others” in the declaration system for filling in.
Table 1 List of main production units, main processes, and production facilities of pollutant discharge units
main
produce
unit
Main process production facility facility parameter unit
To produce
Fate
First name
produce
Line sheet
Yuan a
Dosing liquid dosing facility, solid dosing facility, others
Power, volume,
other
kW, L, others
Engineering bacteria preparation Engineering bacteria preparation room, other area, other m2, other
Inoculation inoculation tank, other volume, other L, other
Culture incubator, biochemical incubator, other volume, other L, other
Fermentation
Disinfection tank, growth liquid tank, maintenance liquid tank, washing liquid tank, fermentation tank, feeding tank,
other
Volume, other L, other
extract
Acidification tank, adsorption tower, liquid storage tank, crystallization tank, conversion tank, filtrate tank, liquid-liquid
Centrifuge, static mixer, extraction tank, extraction tank, filtrate transfer pump, metering
Tank, tank to be filtered, decolorized intermediate tank, preparation tank, extraction equipment, sterilizing filter,
Sleeve type sterilization filter, others
Power, volume,
other
kW, m3, others
purification
Large-capacity cryogenic centrifuge, decolorization tank, crystallization tank, automatic chromatography system, silica gel
Column chromatography system, microfiltration column system, purification system, ultrafiltration system, membrane filter,
Micropore filter, others
Power, volume,
other
kW, m3, others
Solvent recovery distillation kettle, distillation column, other volume, other L, other
Wash bottle
Drum-type bottle washing machine, box-type bottle washing machine, chain type multi-functional ultrasonic cleaning machine, its
Power, processing energy
Force, other
kW, bottle/batch, others
Inactivate
Laminar flow dry heat sterilizer, high pressure steam sterilizer, water bath sterilizer, wet heat
Sterilizer, vacuum sterilizer, others
Power, volume,
other
kW, L, others
dry
Vacuum dryer, three-in-one device, two-in-one device, hot water tank, hot water pump,
Drying heater, micro-heat regenerative dryer, drying condenser, spray drying tower, freeze drying
Machine, others
Power, volume,
other
kW, L, others
Continued
main
produce
unit
Main process production facility facility parameter unit
To produce
Fate
First name
produce
Line sheet
Yuan a
Solid products
Mobile lifting feeder, ball mill, pulverizer, powder mixer, mixer, bottle washer,
Mixer, granulator, tablet press, efficient coating machine, granulator, sealing machine, aluminum
Plastic packaging machine, granulation production line, fully automatic bio-pharmaceutical bottle production packaging line, others
Power, volume,
other
kW, L, others
Liquid products
Mobile lifting feeder, washing tank, vacuum feeder mixer, bottle washer, mixing
Machine, filling machine, sealing machine, aluminum-plastic packaging machine, automatic biopharmaceutical bottle packaging
Line, strapping machine, others
Power, volume,
other
kW, L, others
Semi-solid products
Mobile lifting feeder, heating tank, vacuum feeder mixer, bottle washer, mixing
Machine, filling machine, glue cutting machine, sealing machine, packaging machine, strapping machine, other
Power, volume,
other
kW, L, others
Other other other other
public
unit
R & D center fume hood, reaction tank, others
Air volume, volume,
other
m3/h, L, its
Material storage
Atmospheric pressure tank, fixed roof tank, floating roof tank, cone roof tank, vault roof tank, raw material warehouse,
Treasury, others
Volume, area,
other
m3, m2, which
Wastewater treatment comprehensive wastewater treatment station, domestic sewage treatment station, other treatment capacity, other m3/d, other
Solid waste
Store and dispose
Hazardous waste temporary storage room, sludge temporary storage room, other area, other m2, other
Pure water preparation demineralized water equipment, deionized water equipment, other processing capacity, other m3/d, other
Quality inspection center quality inspection equipment, fume hood, other air volume, other m3/h, other
Clean room clean area purification facilities, other areas m2, other
Animal breeding animal room, other area, other m2, other
Other other other other
a The production line unit named after the product is used to report the human insulin production line, digestive enzyme production line, rabies vaccine production line, and others.
4.3.3 Production facility number
The pollutant discharge unit shall report the internal production facility number, or number and report according to HJ 608.
4.3.4 Product name
The product name should be filled in according to the drug name approved by the State Drug Administration.
4.3.5 Product Specifications and Product Quantity
The unit of product specification is mg/bottle, mg/grain, ml/branch, ml/bottle, ml/bag, mg/tablet, mg/bag, mg/pillar, μg/branch, and others.
Product quantity refers to the annual production quantity corresponding to the product specifications. The unit of product quantity is 100 million bottles/a, 100 million tablets/a, 100 million pieces/a, 100 million bags/a
100 million tablets/a, 100 million packets/a, 100 million pills/a, and others.
4.3.6 Production capacity and measurement unit
The production capacity is the design capacity of the main products, excluding the capacity eliminated or banned by the national or local government. Production capacity measurement unit
Is t/a.
The production capacity of solid preparations and semi-solid preparations is calculated according to formula (1).
ii nBS
1.0 (1)
Where. S--production capacity, t/a;
Bi--i product specifications, mg/bottle, mg/capsule, mg/tablet, mg/pack, mg/pill;
ni--the quantity of the i product, 100 million bottles/a, 100 million tablets/a, 100 million tablets/a, 100 million packets/a, 100 million pills/a
m--the number of product specifications.
The production capacity of liquid preparations is calculated according to formula (2).
ii nBS
1
100 (2)
Where. S--production capacity, t/a;
Bi--i product specifications, ml/piece, ml/bottle, ml/bag;
ni--the quantity of the i-th product, 100 million pieces/a, 100 million bottles/a, 100 million bags/a;
ρi--the density of product i, g/ml;
m--the number of product specifications.
4.3.7 Design annual production time
Fill in according to the environmental impact assessment documents and approval opinions or the local government's mid-year production time for the identification or filing of illegal items. If
There are no relevant documents or the production time is not specified in the document. Fill in the actual production time.
4.3.8 Other
If the pollutant discharge unit needs to explain, it can be filled in.
4.4 Main raw materials and fuels
4.4.1 General principles
The main raw and auxiliary materials and fuels should be filled in with the types of raw and auxiliary materials and fuels, the designed annual consumption and the unit of measurement;
Composition and proportion; fuel composition, including ash, sulfur, volatile matter, calorific value; others.
4.4.2 Raw and auxiliary materials and fuel types
The original and auxiliary materials should be filled with specific substance names. Including. enzymes, microorganisms, solvents, auxiliaries, and others.
Fuel types include. gasoline, diesel, coal, biomass, natural gas, biogas, liquefied petroleum gas, and others.
4.4.3 Design annual consumption and measurement unit
The designed annual consumption is the annual consumption of raw and auxiliary materials and fuels that match the production capacity. The unit of measurement for design annual usage is t/a or
Nm³/a.
4.4.4 Toxic and harmful components and proportion of raw and auxiliary materials
In order to give priority to the inventory of chemicals and the proportion of toxic and hazardous substances or elements specified in relevant documents,
Fill in the actual production value, and the original and auxiliary materials do not contain toxic and hazardous substances or elements.
4.4.5 Other
If the pollutant discharge unit needs to explain, it can be filled in.
4.5 Production and discharge links, pollutants and pollution treatment facilities
4.5.1 General principles
Waste gas production and discharge links, pollutants and pollution treatment facilities include the production and discharge links, pollutant items, and emission forms corresponding to production facilities
(Organized, unorganized), pollution treatment facilities, whether it is a feasible technology, the number and name of the organized discharge outlets, and whether the discharge outlet settings are consistent
Meet the requirements and type of discharge port.
Wastewater categories, pollutants, and pollution treatment facilities include wastewater categories, pollutant projects, pollution treatment facilities, discharge destinations, and discharge parties
Type, discharge rule, discharge port number and name, whether the discharge port setting meets the requirements and the type of discharge port.
4.5.2 Exhaust gas
4.5.2.1 Production and discharge links, pollutant projects, emission forms and pollution treatment facilities
Refer to Table 2 for the content of the waste gas production and discharge links of pollutant discharge units, pollutant items, emission forms, pollution treatment facilities and types of discharge outlets.
Pollutant discharge units are determined according to GB 14554 and GB 37823. If there are local requireme...
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