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Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email. HJ 1063-2019: Technical specification for application and issuance of pollutant permit Pharmacy industry -- Chemical pharmaceutics preparations manufacturing Status: Valid
Basic dataStandard 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 ContentsForeword ... 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 ... 43ForewordIn 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 Preparation1 ScopeThis 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 referencesThe 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 definitionsThe 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 units4.1 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 produ...... |
