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HJ 858.1-2017 English PDF

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HJ 858.1-2017: Technical Specification for Application and Issuance of Pollutant Permit Pharmacy Industry - Active Pharmaceutical Ingredient Manufacturing
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Basic data

Standard ID HJ 858.1-2017 (HJ858.1-2017)
Description (Translated English) Technical Specification for Application and Issuance of Pollutant Permit Pharmacy Industry - Active Pharmaceutical Ingredient Manufacturing
Sector / Industry Environmental Protection Industry Standard
Classification of Chinese Standard Z00
Word Count Estimation 55,551
Date of Issue 2017-09-29
Date of Implementation 2017-09-29
Regulation (derived from) MEP Announcement 2017 No. 53
Issuing agency(ies) Ministry of Ecology and Environment

HJ 858.1-2017: Technical Specification for Application and Issuance of Pollutant Permit Pharmacy Industry - Active Pharmaceutical Ingredient Manufacturing


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People's Republic of China national environmental protection standards Technical Specification for Application and Issuance of Pollutant Permit Pharmacy Industry-Active Pharmaceutical Ingredient Manufacturing 2017-09-29 Posted 2017-09-29 Implementation Ministry of Environmental Protection released I directory Foreword ..II 1 scope of application .1 2 Normative references .1 3 Terms and definitions 3 The basic situation of 4 sewage units to fill the request .3 5 corresponding to the sewage discharge outlet and allowable emission limits .11

6 pollution prevention and control feasible technology

7 Self-monitoring management requirements .22 Environmental Management Ledger and Permit Permit Implementation Report Compilation Requirements .25 9 Actual Emissions Accounting Method 28 10 Compliance Decision Method .30 Appendix A (Informative) Name of API Manufacturing Product 33 Appendix B (informative) the name of the main production facilities .37 Appendix C (Informative) Raw materials commonly used in the manufacture of organic solvents 38 Appendix D (Informative) Raw materials manufacturing unit product benchmark displacement 40 Appendix E (Informative) Operation Management Ledger 42 Appendix F (Informative) Implementation Report .48 Appendix G (informative) sewage unit VOCs actual emissions accounting method .62

Foreword

In order to implement the "Law of the People's Republic of China on Environmental Protection" "Law of the People's Republic of China on Prevention and Control of Air Pollution" "China Law of the People's Republic of China on Prevention and Control of Water Pollution "and other laws and regulations and the" General Office of the State Council on Printing and Distributing the Control of Emission Permit System Implementation Plan Notice (State Office issued (2016) 81), improve the technical support system for sewage permits, guidance and standardization of pharmaceutical Industrial - API manufacturing sewage disposal units permit application and the issuance of work to develop this standard. This standard specifies the pharmaceutical industry - raw materials manufacturing sewage treatment units to apply for the sewage permit and the basic conditions Fill Requirements, the determination of allowable emission limits, actual emissions accounting, compliance assessment methods and self-monitoring, environmental management accounts And the implementation of emission permits and other environmental management requirements, put forward the pharmaceutical industry - raw materials manufacturing pollution prevention and control technology to be begging. When the issuance of a permit for discharge of pollutants is issued by an issuing authority, if it is located in a place prohibited by the laws and regulations from establishing the area, Where the pharmaceutical industry has been clearly stipulated to be eliminated or banned - raw material drug manufacturing sewage disposal units or production facilities, should not be nuclear Pharmaceutical industry - API manufacturing sewage permits. This standard Appendix A ~ Appendix G is an informative annex. This standard is released for the first time. This standard is formulated by the Ministry of Environmental Protection Planning and Finance Department, Ministry of Environmental Protection Science and Technology Standards Division. This standard is mainly drafted by. Hebei University of Science and Technology, Beijing Institute of Environmental Protection, Environmental Protection Department Environmental Engineering Cheng assessment center, Hebei Huayuan Environmental Protection Institute Co., Ltd., Henglian HNA (Beijing) Management Consulting Co., Ltd. National Chemical Pharmaceutical Industry Association, Hebei Province Environmental Science Society. This standard was approved by the Ministry of Environmental Protection on September 29,.2017. This standard since September 29,.2017 come into operation. This standard is interpreted by the MEP.

1 sewage permit application and issuance of technical specifications

Pharmaceutical Industry - Manufacture of APIs

1 scope of application

This standard specifies the pharmaceutical industry - raw materials manufacturing sewage treatment units to apply for the sewage permit and the basic conditions Fill Requirements, the determination of allowable emission limits, actual emissions accounting, technical methods of compliance determination and self-monitoring, environmental management Taiwan account and sewage permit implementation of the report and other environmental management requirements, put forward the pharmaceutical industry - raw materials manufacturing pollution control feasible Surgery requirements. This standard applies to the guidance of the pharmaceutical industry - raw materials manufacturing sewage units to fill in the "sewage permit application form" and in the national row Filing license management information platform Fill the declaration system to fill in the relevant application information, at the same time apply to guide the verification and determination of the issuing authority Pharmaceutical Industry - Permits for the manufacture of APIs for pollutant discharge permits. This standard applies to the further processing of pharmaceutical preparations required for the production of bulk drugs, mainly for the production of pharmaceutical drugs Production of intermediates and manufacture of veterinary drugs (APIs) Discharge of air pollutants and water pollutants discharged by pollutant discharge units License management. Pharmaceutical industry - raw materials manufacturing sewage units, the implementation of GB 13223 of the production facilities and emissions for "thermal power industry Sewage permit application and the issuance of technical specifications "; the implementation of GB 13271 of the production facilities and emissions with reference to the implementation of this standard, Pending the issuance of the boiler's sewage permit application and issuance of technical specifications from its provisions. This standard does not make provisions but the discharge of industrial waste water, waste gas or toxic and harmful air pollutants state pharmaceutical workers Industry - raw materials manufacturing sewage treatment units other pollutant discharge facilities and emissions, with reference to "sewage permit application and the issuance of technical specifications total Then "execute.

2 Normative references

The contents of this standard reference the following documents or terms. Any undated reference documents, the effective version Applicable to this standard. GB 13223 Thermal Power Plant Air Pollutant Emission Standard GB 13271 Boiler air pollutant emission standards GB 14554 Odor pollutant emission standards GB 16297 Integrated Air Pollutants Emission Standard GB 18484 hazardous waste incineration pollution control standards GB 21903 fermentation pharmaceutical industry water pollutant emission standards GB 21904 chemical synthesis pharmaceutical industry water pollutant emission standards GB 21905 extraction of pharmaceutical industry water pollutant discharge standards Determination of Particulate Matter and Gaseous Pollutants in Exhaust of Fixed Pollution Sources GB/T 16157 2GB/T 31962 sewage into the town sewer water quality standards HJ/T 55 Guidelines for Unorganized Emissions Monitoring of Air Pollutants HJ/T 75 Stationary Pollutant Source Discharge Continuous Monitoring Technical Specifications (Trial Implementation) HJ/T 76 Fixed Pollutant Source Discharge Continuous Monitoring System Technical Requirements and Testing Methods (Trial) HJ/T 91 Technical Specifications for Surface Water and Sewerage Monitoring HJ/T 212 pollution source online automatic monitoring (monitoring) system data transmission standards HJ/T 353 water pollution source on-line monitoring system installation technical specifications (Trial) HJ/T 354 water pollution source on-line monitoring system acceptance Technical Specifications (Trial) HJ/T 355 water pollution source on-line monitoring system operation and evaluation of technical specifications (Trial) HJ/T 356 Water Pollution Source Online Monitoring System Data Validation Technical Specifications (Trial) HJ/T 373 fixed pollution source monitoring quality assurance and quality control technical specifications (Trial) HJ/T 397 fixed source exhaust gas monitoring technical specifications HJ 493 sample preservation and management of technical regulations HJ 494 water sampling technical guidance HJ 495 water quality sampling program design specifications HJ 732 Fixed polluting sources - Volatile organic compounds - Sampling airbag method HJ 819 Technical Guidelines for Self-Monitoring of Sewage Disposal Units General HJ 820 Self-Monitoring Technical Guidelines for Sewage Disposal Units Thermal Power Generation and Boilers GB □□ -20 □□ Volatile organic matter emission control standards GB □□ -20 □ □ Pharmaceutical Industry Air Pollutant Emission Standards HJ □□ -20 □□ Discharge Permit Application and Issuance Technical Specifications General HJ □□ -20 □□ Self-Monitoring Technical Guide of Sewage Disposal Unit Fermentation Pharmaceutical Industry HJ □□ -20 □□ Self-monitoring technical guide for sewage disposal units Chemical synthesis Pharmaceutical industry HJ □□ -20 □□ sewage unit self-monitoring technology guide extraction class pharmaceutical industry HJ □□ -20 □□ Environmental Management Ledger and Drainage Permit Implementation Report Technical Specification (Trial Implementation) "Fixed pollution sources permit classification management directory" "Technical requirements for the standardization of sewage outfall (Trial)" (GAC [1996] 470) Measures for the Administration of Automatic Monitoring Facilities for Pollution Sources (Huanfa [2008] No. 6) "Notice on Implementation of Special Emission Limit of Water Pollutants for National Emission Standards in Taihu Lake Basin" (MEP Notice No. 28 of.2008) "On the implementation of the Taihu Lake Basin national pollutant discharge standards of water pollutants discharge limits the administrative area of the public Notice "(Ministry of Environmental Protection Notice No. 30 of.2008) 3 "Pharmaceutical Industry Pollution Prevention and Control Technology Policy" (Ministry of Environmental Protection Announcement No. 18 of.2012) Notice on Implementing Special Emission Limits for Air Pollutants (MEP Announcement No. 14 of.2013) "Volatile Organic Compounds (VOCs) Pollution Prevention and Control Technology Policy" (Ministry of Environmental Protection Notice No. 31 of.2013) Circular on Printing and Distributing the Interim Provisions on the Management of Sewage Discharge Permits (Huishui [2016] No. 186) Circular on the Management of License for Permitting Pollution Caused by Elevated Sources in Thermal Power, Papermaking Industry and Beijing, Tianjin and Hebei Pilot Cities Water [2016] No. 189) Reply on Issues Related to the Implementation of Special Emission Limits for Air Pollutants (Circular Letter No. [2016] 1087) Circular on Issues Concerning the Automatic Monitoring of Elevated Source Contaminants in Beijing-Tianjin-Hebei Region (Circular on Harmonious Environment Circular [2016] 1488 number)

3 Terms and definitions

The following terms and definitions apply to this standard. 3.1 Raw material manufacturing sewage unit active pharmaceutical ingredient manufacturing pollutant emission unit Refers to the further processing of pharmaceutical preparations required for the manufacture of APIs sewage units. 3.2 Permitted emission limits permitted emission limits Refers to the maximum allowable concentration of pollutants (or rate) and the amount of discharge of pollutants permitted by the pollutant discharging units stipulated in the pollutant discharge permit. 3.3 special periods special periods Refers to the national and local deadlines for compliance planning and other relevant environmental management requirements, the pollutant discharge of sewage units There are special requirements of the period, including heavy pollution weather response period and so on. 3.4 Volatile Organic Compounds (VOCs) Refers to the atmospheric photochemical reactions of organic compounds, or according to the prescribed method of measurement or accounting to determine the organic compound Things. According to the characteristics of the industry and environmental management needs, can choose to sum up the main VOCs species method to measure the total Machine compounds (TVOC said), or use the reference material calibration, the detector mixed mixed VOCs synthesis of sound The method should be measured non-methane organic compounds (expressed in NMOC, in terms of carbon), the standard non-methane total hydrocarbon characterization.

4 sewage units fill in the basic requirements

4.1 The basic principle Sewage units should be in accordance with the requirements of this standard in the sewage permit management information platform to declare the system to fill out the "sewage permit Please table "in the corresponding information table. Fill in the system drop-down menu is not included, the local environmental protection authorities have required Fulfillment or sewage units that need to be reported, can add their own content. Provincial environmental protection departments in accordance with environmental quality requirements to improve the management of the increase should be filled in the sewage permit management letter Interest platform to declare the system "with the nuclear power of the local environmental protection department to increase the content of management" column. 4 pollutant discharge units in the application information should assess the status of pollution discharge and environmental management, environmental issues can be raised on the status quo Rectification measures, and fill in the sewage permit management information platform to declare the system "corrective measures" column. The pollutant discharging entity shall fill in the basic information in accordance with the actual conditions, and shall verify the authenticity, legality and completeness of the application materials submitted Negative legal responsibility. 4.2 sewage unit basic information The basic information of the pollutant discharge unit should fill in the name of the unit, the zip code and the type of the industry (when choosing the chemical raw materials Manufacturing or veterinary drug manufacture), whether it is put into production, the date of production, the latitude and longitude of the center of the production and operation site, whether the location belongs to Key areas, whether there are EIA approval documents and symbols (record number), whether there is a local government to identify violations or Filing documents and symbols, whether the total amount of major pollutants distribution plan documents and symbols, the total amount of particulate matter indicators (t/a), two Total sulfur oxides (t/a), total nitrogen oxides (t/a), total chemical oxygen demand (t/a), total ammonia Indicators (t/a), the total amount of other pollutants (if any), whether to implement green enzyme production technology transformation. 4.3 main products and capacity 4.3.1 General principles In reporting "the main products and capacity", the need to choose the type of industry, for the standard production facilities Select chemical Raw materials manufacturing or veterinary drug manufacturing. Implementation of GB 13223 production facilities to choose thermal power industry. The main products and production capacity should report the name of the main production unit, the main process name, the name of the main production facilities, production facilities Facilities number, product name, production capacity, actual output in the recent three years, unit of measurement, design production time and other. 4.3.2 The main production unit Sewage unit main production unit is divided into product named product line unit, public unit. Product named product line The unit is filled in according to the product name in Appendix A, such as cephradine production line, vitamin C production line, amoxicillin production line Wait. If the same production line for the production of different products, the main product name, note that the production of other products. If you include more A production unit, should be filled in each unit. 4.3.3 The main process According to the main process of production line unit process fill, including ingredients, fermentation, reaction, separation, extraction, refining, Drying, finished product, solvent recovery, others. Common unit main process includes material storage system, conveying system, pure water preparation system, circulating water cooling system, for Thermal System, Pneumatic System, Cooling System, Wastewater Treatment System, Exhaust Gas Treatment System, Solid Waste Disposal System, Accident Urgent system, others. 4.3.4 The main production facilities 4.3.4.1 General principles According to the production line unit, the main unit of the common classification of technology, the main production facilities and utilities involved in Appendix B. 54.3.4.2 Mandatory content Equipment that characterizes the production capacity of the plant, production equipment that produces process waste water, production equipment that discharges process exhaust gas, Atmospheric organic liquid storage tanks, organic liquid loading and dispensing facilities, and discharge of toxic and hazardous atmospheric pollutants, emissions of the first category Pollutant production facilities. 4.3.4.3 optional content 1) Pumps and compressors in the production plant; 2) reflux tank in the production plant, buffer tank, liquid separation tank; 3) Operating pressure is greater than atmospheric organic liquid storage tank; 4) equipment for process parameter measurement and product quality testing; 5) The production unit contains equipment and pipeline components through which volatile organic compounds flow. 4.3.4.4 Production Facilities Number Sewage units fill in the number of internal production facilities; if the sewage unit does not have an internal production facility number, according to the water bodies [2016] No. 189 in Annex 4 "fixed sources of pollution (water, air) coding rules (Trial)" number and fill in. 4.3.4.6 Facilities parameters Facilities parameters are divided into parameter name, design value, unit of measurement, etc., facility parameters such as diameter, area, volume, pressure, Rated power, flow, air supply, design displacement, the maximum capacity, the maximum heat load, thermal efficiency and so on. 4.3.4.7 Product Name Please refer to Appendix A for the product name. 4.3.4.8 production capacity, the actual production and measurement units in the past three years Production capacity of the main product design capacity, excluding the national and local governments to be eliminated or banned capacity. Nearly three years The actual production for the actual number of (not put into operation and put into operation less than one year raw material manufacturing sewage discharge units do not need to fill in, full operation of a Annual but less than three years of raw materials manufacturing sewage units fill the cycle of reporting). Capacity and yield measurement units are t/a. 4.3.4.9 Design annual production time According to the environmental impact assessment documents and approval, the local government to identify violations of the project or filing documents to determine the annual production hours Fill in the number. 4.3.4.10 Others Sewage units need to explain the contents, you can fill in. 4.4 The main raw materials and fuels 4.4.1 General principles Fill in the main raw and auxiliary materials (except for organic solvents), organic solvents and fuels, all should be filled in. The main raw and auxiliary materials (except for organic solvents) should report the types of raw and auxiliary materials, design annual usage, unit of measurement, purity, Toxic and harmful ingredients, other. 6 Organic solvents should be submitted to the name of the solvent, the design of the amount of use, measurement units, purity, and others. Fuel should be reported on the type of fuel, ash, sulfur, volatile, calorific value, design annual usage, other. 4.4.2 raw and auxiliary materials and fuel types Raw materials (except for organic solvents) should be filled in the name of specific substances, by the reactants, solubilizers, additives, emulsifiers, Recipients, diluents, chelating agents, enzymes, catalysts, pH regulators and the like are classified. Refer to Appendix C for the name of organic solvent. Fuel types include. fuel coal, crude oil, heavy oil, diesel oil, fuel oil, shale oil, natural gas, biogas, liquid fossil Oil & Gas, CBM, shale gas, others. 4.4.3 Design Year usage and unit of measurement The designed annual usage is the annual consumption of raw and auxiliary materials and fuel that match the production capacity. Design annual usage measurement unit is t/a Or Nm³/a. 4.4.4 Purity of raw and auxiliary materials The purity of organic solvents in raw and auxiliary materials is required, expressed as a percentage; the purity of other raw and auxiliary materials is optional. 4.4.5 toxic and hazardous ingredients and their proportions Raw materials, lead, cadmium, arsenic, nickel, mercury, chromium content, may refer to the design value or the actual value of the previous year report. 4.4.6 fuel ash, sulfur, volatile and calorific value Fuel coal need to fill in ash, sulfur, volatile and low calorific value; other fuel fill sulfur and low calorific value. Can refer to Design value or actual value of the previous year report. 4.4.7 Other Sewage units need to explain the contents, you can fill in. 4.5 production of sewage links, pollutants and pollution control facilities 4.5.1 Exhaust gas 4.5.1.1 General principles Sewage emissions Sewage links, pollutants and pollution control facilities, including production facilities corresponding to the production of sewage links, types of pollutants, Emission forms (organized, unorganized), pollution control facilities, feasible or not, discharge number, discharge setting Whether the norms and the type of discharge. 4.5.1.2 The main pollutant gas emission links, emission forms and pollution control facilities name The main pollutant emission unit sewage sector name and name of pollution treatment facilities to fill in Table 1, the contents of which emissions The name of the link is named after the pollution-producing links corresponding to the production facilities (facilities) that produce the exhaust gas, and the pollutants produced by the production process Equipment (facilities) to fill in. The form of emissions is divided into organized and unorganized. Pollution control facilities are divided into process organic waste gas, Process acid-base waste gas, process dust-containing waste gas, fermentation waste gas, waste gas from tank farm, waste gas from waste water treatment station, 7 furnace flue gas, hazardous waste incinerator flue gas treatment facilities, and biogas purification facilities. Table 1 main waste gas production and pollution control facilities name list Production process Main production facilities Name of pollution control facilities Name of pollution control facilities Ingredients Liquid ingredients facility Organic liquid ingredients process organic waste gas treatment facilities Acid-base regulation process acid-base exhaust gas treatment facilities Solid Batching Machine, Granulating Screening Machine, Crusher Solid Ingredients, Granulating Screening, Crushing Process Dust-Fueled Gas Treatment Facilities Fermentation Seed cans, fermentors, sterilization cans, ingredients fill Add cans Seed culture, fermentation, disinfection, feed fermentation exhaust gas treatment facilities Reaction Reactor, Condensation Tank, Cracking Tank Reaction, Condensation, Cracking Process Organic Waste Gas Treatment Facility Separated Centrifuge Process organic waste gas treatment facilities Frame filter press frame pressure filter Filter Drum filter drum Membrane separator membrane separation Extraction tank extraction Tube separator tube separation extract Acidification tank acidification Process organic waste gas treatment facilities Adsorption tower adsorption Liquid storage tank Reverse osmosis equipment reverse osmosis Crystallization tank crystallization Dryer dry Conversion tank conversion Leaching equipment leaching Refining decolorization tank decolorization of organic waste gas treatment facilities Crystallization tank crystallization process organic waste gas tr...

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