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HJ 1063-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry -- Chemical pharmaceutics preparations manufacturing
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Technical specification for application and issuance of pollutant permit Pharmacy industry -- Chemical pharmaceutics preparations manufacturing
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HJ 1063-2019
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Standard similar to HJ 1063-2019 HJ 1060 HJ 1061 HJ 1059 Basic data | Standard ID | HJ 1063-2019 (HJ1063-2019) | | Description (Translated English) | Technical specification for application and issuance of pollutant permit Pharmacy industry -- Chemical pharmaceutics preparations manufacturing | | Sector / Industry | Environmental Protection Industry Standard | | Word Count Estimation | 47,413 | | Date of Issue | 2019-12-10 | | Date of Implementation | 2019-12-10 | | Issuing agency(ies) | Ministry of Ecology and Environment | HJ 1063-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry -- Chemical pharmaceutics preparations 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-Manufacturing of Chemical Preparations)
National Environmental Protection Standard of the People's Republic of China
Technical Specifications for Sewage Permit Application and Issuance
Pharmaceutical Industry-Chemical Preparation
Technical specification for application and issuance of pollutant permit
Pharmacy industry-Chemical pharmaceutics preparations 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 Feasible technical requirements for pollution prevention ... 15
7 Management requirements for self-monitoring ... 17
8 Requirements for the preparation of an environmental management ledger and an emission permit execution report ... 20
9 Accounting method for actual emissions ... 22
10 Compliance Determination Method ... 24
Appendix A (Informative) Reference Table of Pollution Prevention Techniques ... 26
Appendix B (Informative) Reference Table of Environmental Management Ledger Records ... 28
Appendix C (Informative) Reference Table for Sewage Permit Implementation Report ... 32
Appendix D (Informative) Accounting Method for Actual Emissions of Exhaust Pollutants ... 43
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 of sewage permits, guide and standardize the sewage discharge units of the pharmaceutical industry-chemical drug manufacturing
Work on license application and issuance to develop this standard.
This standard specifies the basic requirements for filling out and reporting requirements for the application and issuance of pollution permits for the pharmaceutical industry-chemical drug product manufacturing discharge units,
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-chemical drug preparation 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-Chemical Preparation
1 Scope
This standard specifies the basic requirements for filling out and reporting requirements for the application and issuance of pollution permits for the pharmaceutical industry-chemical drug product manufacturing discharge units,
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-chemical drug product manufacturing and discharge units on the national sewage permit management information platform (the following simplified
(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 discharge permit management of air pollutants and water pollutants discharged by the sewage production units of chemical pharmaceutical preparations; veterinary chemicals
The discharge permit management of air pollutants and water pollutants discharged by the pollutant discharge units of pharmaceutical products manufacturing also applies to this standard.
Pharmacy-chemical drug product manufacturing and discharge unit
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 Sewage Permit Application and Issuance of Technical Specifications for Boilers (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 21908 Discharge Standard for Water Pollutants in 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 858.1 Application for Sewage Permit and Issuance of Technical Specifications Pharmaceutical Industry-API Manufacturing
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 the Administrative Region Scope of Implementing the National Pollutant Discharge Standard for Water Pollutants in the 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
Pollutant emission unit of chemical pharmaceutics preparations
manufacturing
Refers to the sewage discharge unit for the manufacture of chemical preparations directly used for the prevention and diagnosis of human diseases.
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
The pollutant discharge unit shall fill in the corresponding information on the pollutant discharge permit platform in accordance with the requirements of this standard. Local ecological environment not included in the sewage permit platform
If the competent authority in charge of the environment has a requirement to fill in the report or the polluting unit considers it necessary to fill in the report, it may add the content on its own.
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 pollutant discharge unit should be filled in with the name of the unit, whether it needs to be corrected, the type of pollution permit management, postal code, industry category (fill in
At the time of report, select "Pharmaceutical Industry-Chemical Preparation Manufacturing", "Pharmaceutical Industry-Veterinary Drug Manufacturing-Chemical Preparation Manufacturing"),
Whether it is put into production, the date of production, the latitude and longitude of the center of the production and operation site, and whether the location is an environmentally sensitive area (such as a key atmospheric control area,
Total nitrogen and total phosphorus control area, etc.), whether it is located in the industrial park, the name of the industrial park to which it belongs, the environmental protection assessment document for the construction project
Number (recording number), local government's identification or filing document number of illegal items, main pollutant total distribution plan document number,
Total particulate matter (t/a), total sulfur dioxide (t/a), total nitrogen oxides (t/a), total volatile organics (t/a),
Total chemical oxygen demand indicator (t/a), total ammonia nitrogen indicator (t/a), other total pollutant indicators (if any) involved, etc.
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 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 main processes and production facilities, you can select "Other" in the declaration system to fill in.
Table 1 List of the main production units, main processes and production facilities of pollutant discharge units
main production
unit
Main process production facility facility parameter unit
solid preparations
Production unit
dry
Vacuum dryer, double cone dryer, chamber dryer, fluidized bed dryer
Dryer, spray dryer, infrared dryer, microwave dryer, dry
Drying heater, drying condenser, spray drying tower, ebullating bed, three-in-one
Device, two-in-one device, others
Processing capacity, other kg/batch, other
Shatter
Mechanical pulverizer, grinding pulverizer, air-flow pulverizer, low
Thermo mill, ball mill, micronizer, roller mill, crushing
Machine, others
Production volume, power, other
kg/h, kW, others
Sieves whole grain sieving machine, other meshes, other meshes, other
mixing
Trough mixer, drum mixer, hopper mixer, cone mixer
Machine, solid batching machine, liquid batching facility, others
Capacity, other kg/h, other
Granulation
Mixer, shaker, dust trap, granulator, granulator,
Vacuum feeder, extrusion granulator, roll compactor, spray
Granulator, compound granulator, others
Production volume, mesh number, others
kg/h, mesh, grain/min,
other
Tablet Press Single Press, Rotary Tablet Press, Other Production Volume, Other 10,000 Tablets/h, Other
Coating and coating machine, tilting coating pan, rotating coating device, other processing capacity, other kg/time, other
Packing
Packing machine, roll mode soft capsule machine, fully automatic hard capsule filling machine,
other
Production volume, others
Pack/min, pcs/min,
other
Sterilization cabinet, other volume, other L, other
Other other other other
Semi-solid
Agent production order
Cutting glue cutter, slicer, other processing capacity, other kg/h, other
Stirring batching pot, homogenizer, other processing capacity, other kg/h, other
heating
Heating tank, hot air circulation incubator, hot-press coating machine, rubber mixer,
other
Volume, throughput, other
m3, kg/h, other
Filling and sealing machine, other production volume, other bags/min, other
Other other other other
Continued
main production
unit
Main process production facility facility parameter unit
Liquid preparation
Production unit
Clean
Drum bottle washer, box bottle washer, chain multifunctional ultrasonic cleaning
Washing machine, others
Production volume, other bottles/min, other
Drying vacuum dryer, drying heater, other flow, other m3/h, other
Filtration filter, pressure filter, vacuum filter, other processing capacity, other m3/h, other
Filling Filling Machine, Ampoule Drawing Filling and Sealing Machine, Other Production Volume, Other Bottles/min, Other
Other other other other
Gas preparation
Production unit
Drug configuration automatic aerosol filling machine, other production volume, other cans/h, other
Filling propellant automatic aerosol filling machine, other production volume, other tanks/h, other
Other other other other
Common unit
Quality inspection center quality inspection equipment, fume hood, other air volume, other m3/h, other
R & D center fume hood, other air volume, other m3/h, other
Animal breeding animal room, other area, other m2, other
Clean room clean area purification facilities, other air volume; area, other m3/h; m2, other
Material storage
Atmospheric pressure tank, fixed roof tank, floating roof tank, raw material warehouse, finished product warehouse,
other
Volume, area, other m3, m2, other
Loading and unloading transfer tanker, crane tube, other
Loading capacity, diameter, others
t, mm, other
Pure water preparation demineralized water equipment, deionized water equipment, other processing capacity, other m3/d, other
Wastewater treatment comprehensive wastewater treatment station, domestic sewage treatment station, other treatment capacity, other m3/d, other
Exhaust gas treatment adsorption tank, bag dust collector, filter dust collector, absorption tower, other processing capacity, other m3/h, other
Temporary storage of solid waste
Dispose
Hazardous waste temporary storage room, sludge temporary storage room, other area, other m2, other
Other other other other
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 of the solid preparation production unit is to report the freeze-dried powder injection, powder injection, tablet, capsule, granule, sustained-release controlled-release tablet, intestine
Dissolving pellets, fast disintegrating tablets, dispersing tablets, etc .;
Fill in the product name of the semi-solid preparation production unit, such as cream, suppository, gel, etc .;
Fill in the product name of the liquid preparation production unit with injection, infusion, oral solution, topical solution, drops, etc .;
The product name of the gas preparation production unit is filled with aerosol, spray, etc.
4.3.5 Product Specifications and Product Quantity
The unit of product specification is mg/tablet, mg/capsule, ml/bottle, ml/bag, ml/branch, mg/pack, mg/pillar, others.
Product quantity refers to the annual production quantity corresponding to the product specifications. The unit of product quantity is 100 million tablets/a, 100 million tablets/a, 100 million bottles/a, 100 million bags/a,
100 million pieces/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 product, 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, semi-solid preparations and gas preparations is calculated according to formula (1).
ii nBS
1.0 (1)
Where. S--production capacity, t/a;
Bi--Specification of product i, unit is mg/bottle, mg/grain, mg/tablet, mg/pack, mg/pillar
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--the i product specification, the unit is 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 annual production time in the environmental impact assessment document and approval opinions or the local government's identification or filing document of the illegal project.
If there is no relevant document 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
Raw materials refer to the raw materials used in the manufacture of chemical preparations. See Appendix A of HJ 858.1.
Excipients refer to chemicals or other substances added in the process and wastewater and waste gas treatment processes, and specific substance names should be filled in, such as. lake
Powder, sodium carboxymethyl cellulose, dextrin, sucrose, sorbitol, water for injection, glycerin, propylene glycol, activated carbon, coagulant, etc.
Fuel types include. coal, diesel, 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 requirements for emission stan...
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