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HJ 1064-2019 English PDF

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HJ 1064-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry-Chinese traditional medicine manufacturing
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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
HJ 1064-2019	English	969	Add to Cart	6 days [Need to translate]	Technical specification for application and issuance of pollutant permit Pharmacy industry-Chinese traditional medicine manufacturing	Valid	HJ 1064-2019

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Basic data

Standard ID	HJ 1064-2019 (HJ1064-2019)
Description (Translated English)	Technical specification for application and issuance of pollutant permit Pharmacy industry-Chinese traditional medicine manufacturing
Sector / Industry	Environmental Protection Industry Standard
Word Count Estimation	42,484
Date of Issue	2019-12-10
Date of Implementation	2019-12-10
Issuing agency(ies)	Ministry of Ecology and Environment

HJ 1064-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry-Chinese traditional medicine manufacturing

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(Sewage Permit Application and Issuance Technical Specifications Pharmaceutical Industry-Chinese Patent Medicine Production) National Environmental Protection Standard of the People's Republic of China Technical Specifications for Sewage Permit Application and Issuance Pharmaceutical industry-Chinese patent medicine production Technical specification for application and issuance of pollutant permit Pharmacy industry-Chinese traditional medicine manufacturing 2019-12-10 Release 2019-12-10 Implementation Released by the Ministry of Ecology and Environment

Foreword ... 1 Scope ... 1 2 Normative references ... 1 3 Terms and definitions ... 3 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 ... 14 7 Management requirements for self-monitoring ... 16 8 Requirements for Compiling Environmental Management Ledger and Pollutant Discharge Permit Report ... 19 9 Accounting method for actual emissions ... 21 10 Compliance Determination Method ... 21 Appendix A (informative appendix) Names of raw and auxiliary materials for the production of proprietary Chinese medicines ... 24 Appendix B (Informative) Reference Table of Pollution Prevention Techniques ... 25 Appendix C (Informative) Reference Table of Environmental Management Ledger Records ... 28 Appendix D (Informative) Reference Table for Annual Implementation Report of Sewage Permits ... 31 Appendix E (Informative) Accounting Methods for Pollutant Emissions of Exhaust Gas and Waste Water ... 36

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 (State Office Development No..2016 ﹞ 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 pharmaceutical industry-Chinese patent medicine production and sewage discharge units sewage permits Apply for and approve the work and develop this standard. This standard specifies the basic requirements for reporting and permitting the discharge of pollution permit applications and approvals for pharmaceutical industry-Chinese patent medicine production and discharge units Method for determining the limit value, actual emission accounting and compliance determination, as well as self-monitoring, environmental management ledger and pollution permit implementation report Such as environmental management requirements, put forward the feasible technical requirements for the pharmaceutical industry-Chinese patent medicine production pollution prevention. Appendices A to E 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-Chinese patent medicine production

1 Scope

This standard specifies the basic requirements for reporting and permitting the discharge of pollution permit applications and approvals for pharmaceutical industry-Chinese patent medicine production and discharge units Method for determining the limit value, actual emission accounting and compliance determination, as well as self-monitoring, environmental management ledger and pollution permit implementation report Such as environmental management requirements, put forward feasible technical requirements for pollution prevention. This standard is applicable to guide the pharmaceutical industry-Chinese patent medicine production and sewage units on the national sewage permit management information platform (hereinafter referred to as sewage Licensing platform) Fill in relevant application information, which is applicable to guide the issuing authority to review and determine the permit requirements of the pollutant discharge unit of the pollutant discharge unit. This standard also It is applicable to guide the application and issuance of the pharmaceutical industry-Chinese medicine decoction processing and sewage disposal unit. This standard is applicable to the discharge permit management of air pollutants and water pollutants discharged by Chinese patent medicine production and discharge units. Processing and decontamination of Chinese medicine decoction pieces Units, Tibetan medicine and Mongolian medicine and other traditional medicine sewage discharge units, veterinary medicine production and discharge units similar to traditional Chinese medicines discharge air pollutants, The discharge permission management of water pollutants can be implemented with reference to this standard. Pharmaceutical Industry-In the production and discharge unit of proprietary Chinese medicines, the production facilities implementing the "Emission Standard for Air Pollutants of Thermal Power Plants" (GB 13223) Shihe discharge port is applicable to the “Technical Specifications for the Application and Issuance of Pollutant Discharge Permits in the Thermal Power Industry”; 13271) production facilities and discharge outlets are applicable to "Boiler for Sewage Permit Application and Issuance of 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 21906 Water Pollutant Discharge Standard for Chinese Medicine 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 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 Chinese traditional medicine manufacturing pollutant emission unit It refers to the use of traditional Chinese medicine as raw materials, under the guidance of traditional Chinese medicine theory, in order to prevent and treat diseases, according to prescribed prescriptions and preparation processes It is processed into a sewage unit of a certain dosage form of a traditional Chinese medicine product. 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 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. 3.4 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.

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 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 report, select "Pharmaceutical Industry-Traditional Chinese Medicine Piece Processing", "Pharmaceutical Industry-Chinese Patent Medicine Production", "Pharmaceutical Industry-Veterinary Medicine System" Manufacturing-processing of traditional Chinese medicine pieces "," pharmaceutical industry-manufacturing of veterinary drugs-production of traditional Chinese medicine "), whether to put into production, the date of production, production and operation The latitude and longitude of the center of the site, whether the site is an environmentally sensitive area (such as a key atmospheric control area, a total nitrogen and total phosphorus control area, etc.), is it located in The name of the industrial park, the affiliated industrial park, the construction project environmental impact assessment document approval opinion document number (recording number), Document number of the regulatory project, document number of main pollutant total distribution plan, total particulate matter index (t/a), sulfur dioxide Total indicator (t/a), Total nitrogen oxides indicator (t/a), Total volatile organic compounds indicator (t/a), Total chemical oxygen demand indicator (t/a), Total ammonia nitrogen indicator (t/a), total other 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 main production units, main processes and production facilities of the pharmaceutical industry-Chinese patent medicine production and sewage units Main production unit main process production facility facility parameter unit Processing Unit Dry-processed automatic temperature-controlling medicine-driving machine, drum-type medicine-driving machine, medicine-fired unit, calcining machine, other power Wet-fired cooking pot, peony, roaster, other power kW Other other other other Refining unit Dosing machine, other power kW Water extraction extraction tank, other effective volume m3 Alcohol precipitation tank, other effective volume m3 Alcohol extraction extraction tank, other effective volume m3 Concentration tank, other power kW dry Drying heater, drying condenser, spray drying tower, chamber dryer, fluidized bed dryer, spray dryer, red External dryer, microwave dryer, others Power kW Ethanol recovery preheater, plate heat exchanger, high-efficiency alcohol recovery concentrator, alcohol recovery tower, ethanol storage tank, other power kW Medicine residue discharge residue, medicine residue discharge space, other area m2 Other other other other Preparation unit solid preparations Granulator, pelletizer, drying heater, drying condenser, spray drying tower, chamber dryer, fluidized bed dryer, Spray dryer, infrared dryer, microwave dryer, others Power kW Semi-solid preparation heating tank, hot air circulation incubator, hot-press coating machine, other power kW Liquid preparation bottle washing machine, filling machine, other power kW Gas preparation filling machine, other power kW Common unit Wastewater treatment integrated wastewater treatment station, domestic sewage treatment station, other processing capacity m3/d Storage area of solid waste, other area m2 Pure water preparation demineralized water equipment, deionized water equipment, other processing capacity m3/d 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. If different products are produced by the same production unit, Fill in all product names. 4.3.5 Product Specifications and Product Quantity The unit of product specification is mg/tablet, mg/grain, mg/pill, mg/pack, mg/bottle, ml/branch, ml/bottle, ml/bag, others. Product quantity refers to the annual production quantity corresponding to the product specifications. The unit of the product quantity is 100 million tablets/a, 100 million tablets/a, 100 million pills/a, 100 million packets/a, 100 million pieces/a, 100 million bottles/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, semi-solid preparations and gas 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 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 The raw materials include the processing of traditional Chinese medicine decoction pieces and the basic raw materials for the production of proprietary Chinese medicines. Specific substance names should be filled in, see Appendix A. Excipients refer to chemicals or other substances added in the process and wastewater and waste gas treatment processes, including catalysts, solvents, additives, etc. See Appendix A. 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 waste gas production and discharge links of pollutant discharge units, pollutant items, emission forms and pollution treatment facilities. Sewage unit Dye items are determined according to GB 14554 and GB 37823. Where there are local requirements for emission standards, they shall be determined strictly in accordance with local emission standards. Table 2 Pharmaceutical industry-Chinese patent medicine production and discharge units Main production unit main Craft Production facilities Exhaust emissions Dirty link Pollutant project Emission Pollution control facilities exhaustion hole Types of Whether the pollution treatment process is a feasible technology Processing Unit Dry method Burn Automatic temperature-controlling medicine-driving machine, drum-type medicine Machine, roasting machine, calcining machine Dry fire Exhaust gas Particles organized / Unorganized Bag dust removal, electrostatic dust removal, wet dust removal, others Yes □ No □ If it does not belong to "6 Pollution prevention technology Technical requirements " Relevant evidence should be provided Ming materials General vent Absorption of odor concentration, adsorption of activated carbon, others Refining unit Dosing machine dosing exhaust particulate matter Organized / Unorganized Bag dust removal, electrostatic dust removal, wet dust removal, others General vent Alcohol precipitation tank alcohol precipitation exhaust gas NMHCa, TVOCa Organized / Unorganized Absorption, catalytic oxidation, others Alcohol extraction tank, alcohol extraction waste gas, NMHCa, TVOCa Organized / Unorganized Condensation, absorption, catalytic oxidation, others Concentrated concentration tank concentrated exhaust gas NMHCa, TVOCa Organized / Unorganized Condensation, absorption, catalytic oxidation, others dry Dry heater, dry condenser, Spray drying tower, chamber dryer, fluidization Bed dryer, spray dryer, red External dryer, microwave dryer Dry exhaust particulates Organized / Unorganized Bag dust removal, electrostatic dust removal, wet dust removal, others NMHCa, TVOCa Organized / Unorganized Absorption, ...

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