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HJ 881-2017 English PDF

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HJ 881-2017: Self-monitoring technology guidelines for pollution sources. Pharmaceutical industry extraction products category
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Basic data

Standard ID HJ 881-2017 (HJ881-2017)
Description (Translated English) Self-monitoring technology guidelines for pollution sources. Pharmaceutical industry extraction products category
Sector / Industry Environmental Protection Industry Standard
Classification of Chinese Standard Z05
Classification of International Standard 13.020
Word Count Estimation 10,121
Date of Issue 2017-12-21
Date of Implementation 2018-01-01
Quoted Standard GB 14554; GB 16297; GB 21905; HJ/T 2.3; HJ/T 91; HJ/T 166; HJ 442; HJ 819; HJ 820
Regulation (derived from) Ministry of Environmental Protection Bulletin 2017 No. 76
Issuing agency(ies) Ministry of Ecology and Environment
Summary This standard stipulates the general requirements for the self-monitoring of the extractive pharmaceutical industry, the development of monitoring plans, and the basic contents and requirements for information recording and reporting. This standard is applicable to monitoring the discharge of water, air pollutants, noise and the impact on the quality of the surrounding environment of the extraction-type pharmaceutical industry discharge units. This standard also applies to veterinary drug production units that have similar structure to the extracted drugs. Self-monitoring requirements for self-provided thermal power generating units (plants) and supporting power boilers shall be implemented in accordance with HJ 820.

HJ 881-2017: Self-monitoring technology guidelines for pollution sources. Pharmaceutical industry extraction products category


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(Sewage units self-monitoring technical manual extraction of pharmaceutical industry) People's Republic of China national environmental protection standards Sewage units self-monitoring technical guide Extraction of pharmaceutical industry Self-monitoring technology guidelines for pollution sources -Pharmaceutical industry extraction products category 2017-12-21 Published 2018-01-01 implementation Ministry of Environmental Protection released I directory Foreword .. ii 1 Scope 1 2 Normative references 1

3 Terms and definitions

4 Self-monitoring of the general requirements .2 5 monitoring program development .2 6 Information Recording and Reporting 6 7 Other .7 Ii Foreword To implement the "Law of the People's Republic of China on Environmental Protection" "Water Pollution Prevention and Control Law of the People's Republic of China" "People's Republic of China Law of the People's Republic of China on Prevention and Control of Atmospheric Pollution "to guide and standardize the self-monitoring of the sewage collection units in the pharmaceutical industry and formulate this standard. This standard proposes the extraction of the pharmaceutical industry, the general requirements of self-monitoring of sewage disposal units, monitoring program development, information recording And the basic content and requirements of the report. This standard is released for the first time. This standard by the Environmental Protection Department of Environmental Monitoring Division, Science and Technology Standards Division proposed and organized. The main drafters of this standard. China Environmental Monitoring Station, Nanjing Environmental Monitoring Center Station. This standard MEP approved on December 21,.2017. This standard since January 01,.2018 into effect. This standard is interpreted by the MEP. 1 sewage treatment unit self-monitoring technology guide extracted pharmaceutical industry

1 scope of application

This standard proposes the extraction of the pharmaceutical industry, the general requirements of self-monitoring of sewage disposal units, monitoring program development, information recording And the basic content and requirements of the report. This standard applies to the extraction of pharmaceutical industry sewage units in the production and operation of the discharge of water, air pollutants, noise As well as its impact on the surrounding environment quality monitoring. This standard also applies to the extraction of drugs similar to the structure of veterinary drug production units. Own-owned thermal power plant (plant), self-supporting boiler requirements in accordance with the implementation of HJ 820.

2 Normative references

This standard references the following documents or the terms of them. For dated references, the effective version is valid Used for this standard. GB 14554 Odor pollutant emission standards GB 16297 Integrated Air Pollutants Emission Standard GB 21905 extraction of pharmaceutical industry water pollutant discharge standards HJ/T 2.3 Environmental Impact Assessment Technical Guidelines Surface water environment HJ/T 91 Technical Specifications for Surface Water and Sewerage Monitoring HJ/T 166 Soil Environmental Monitoring Technical Specifications HJ 442 Marine environment monitoring code 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 "National List of Hazardous Wastes" (Ministry of Environmental Protection, National Development and Reform Commission, Ministry of Public Security Order No. 39)

3 Terms and definitions

GB 21905 and defined by the following terms and definitions apply to this standard. 3.1 Extract extract Refers to treatment by a solvent such as ethanol, distillation, dehydration, under pressure or centrifugal force, or by other chemical or mechanical means Mechanical process from the material preparation (such as the composition or juice). 3.2 Extraction Pharmacy Refers to the use of physical, chemical, biochemical methods, the organisms play an important physiological role of the basic material 2 after extraction, separation, purification and other means of manufacturing drug process. 3.3 Direct discharge Refers to the discharge of water pollutants directly to the environmental water body behavior. 3.4 Indirect discharge Refers to the sewage discharge unit to the public sewage treatment system discharge of water pollutants behavior. 3.5 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. 4 Self-monitoring of the general requirements Sewage units should check their own sources of pollution, pollutants and potential environmental impact indicators, the development of monitoring programs, set And maintain the monitoring facilities, carry out self-monitoring according to the monitoring plan, conduct quality assurance and quality control, record and save the monitoring Data and information, in accordance with the law to the public monitoring results.

5 monitoring program development

5.1 Wastewater discharge monitoring 5.1.1 monitoring point All extraction units of the pharmaceutical industry sewage units shall be in the total discharge of waste water, rainwater discharge to set the monitoring point, domestic sewage Water alone into the external environment must be set in the sewage outlet monitoring points. 5.1.2 Monitoring Indicators and Monitoring Frequency Wastewater discharge monitoring sites, monitoring indicators and the minimum monitoring frequency in accordance with Table 1 implementation. Table 1 Wastewater discharge monitoring points, monitoring indicators and minimum monitoring frequency Monitoring point monitoring indicators Monitoring frequency Direct emissions indirect emissions Wastewater Total discharge Flow, pH, COD, ammonia nitrogen automatic monitoring Total Phosphorus Day (Automatic Monitoring a) Month (Automatic Monitoring a) Total Nitrogen Day b (Day b) Suspended solids, color, animal and vegetable oils, five days of biochemical oxygen demand, total organic carbon, Acute toxicity (HgCl2 toxicity equivalent) Rose quarter

3 monitoring points monitoring indicators

Monitoring frequency Direct emissions indirect emissions domestic sewage exhaustion hole Flow, pH, COD, ammonia nitrogen automatic monitoring - Total phosphorus month (automatic monitoring a) - Total Nitrogen Month (Day b) - Suspended solids, on the 5th biochemical oxygen demand, animal and vegetable oil month - Rainfall discharge pH, COD, ammonia nitrogen, suspended solids Day c Note. If the municipal department or above designated by the monitoring indicators listed in the table clearly requires the installation of automatic monitoring equipment at the municipal level or above, automatic monitoring shall be taken. Note. a total water quality control of total phosphorus in the implementation of the region, the total phosphorus to take automatic monitoring. b Total nitrogen in water environment quality control Total control area of nitrogen, the minimum daily monitoring frequency of nitrogen is executed on a daily basis. After the automatic monitoring technical specifications are released, Must take automatic monitoring. c Monitor emissions by day. 5.2 Exhaust emissions monitoring 5.2.1 Organized emission monitoring sites, monitoring indicators and monitoring frequency 5.2.1.1 Monitoring points Exhaust gas of each process is discharged to the external environment through an exhaust pipe and the like, and an exhaust gas pipe in front of the exhaust pipe or the exhaust pipe is to be installed Measuring point. 5.2.1.2 Monitoring indicators and monitoring frequency Organized exhaust monitoring points in each process, monitoring indicators and the minimum monitoring frequency in accordance with Table 2 implementation. For multiple sources of pollution Or production equipment share an exhaust pipe, monitoring points can be arranged in a common exhaust pipe, monitoring indicators should cover the corresponding Pollution or production equipment monitoring indicators, the minimum monitoring frequency in accordance with the strict implementation. Table 2 Organized emission monitoring sites, monitoring indicators and minimum monitoring frequency Monitoring points of production process monitoring points Type of monitoring indicators Monitoring frequency Raw material selection and pre-orders Reason, cleaning, smashing Broken, screening and other settings Prepared exhaust or closed car Between the exhaust tube Process dust particles exhaust quarter Extraction, refining, dissolving Recycling Acidification tank, adsorption tower, Crystallization tank, distillation recovery Exhaust tube and other equipment Process organic waste gas Volatile Organic matter a month Characteristics of pollutants b years dry Dry the column and dry in vacuo Device, vacuum pump and other dry Equipment exhaust Process dust particles exhaust quarter Process organic waste gas Volatile Organic matter a month Characteristics of pollutants b years

4 monitoring points of production processes monitoring types of exhaust gas emissions monitoring frequency

Finished product Crushed, ground, packed Exhaust tube and other equipment Process dust particles exhaust quarter other Waste temporary exhaust emissions Volatile organic matter a quarter Odor concentration, characteristic pollutants b years Hazardous waste incinerator Gas cylinder Soot, sulfur dioxide, nitrogen oxides automatic monitoring Smoke blackness, carbon monoxide, chlorination Hydrogen, hydrogen fluoride, mercury and its compounds, Cadmium and its compounds, (arsenic, nickel and Its compounds), lead and its compounds, (Antimony, chromium, tin, copper, manganese and its Compound) Six months Dioxin year Sewage treatment facilities exhaust Volatile Organic matter a month Odor concentration, characteristic pollutants b years Note 1. Exhaust gas monitoring shall be based on the corresponding monitoring and analysis methods, technical specifications simultaneously monitor the flue gas parameters. Note 2. If the municipal department of environmental protection and above designated by the monitoring indicators set out in the table clearly requires the installation of automatic monitoring equipment, automatic monitoring shall be taken. Note. a According to the characteristics of the industry and environmental management needs, volatile organic compounds may choose to quantitatively sum up the main VOCs species Total organic Compounds, or non-methane organic compounds by the method of calibrating the reference material and detecting the comprehensive response of the detector to the VOCs in the mixed sample. Because at this stage the country has not yet introduced a standard test method, this standard temporary use of non-methane hydrocarbons as a comprehensive control of volatile organic compounds emissions Indicators, to be released after the relevant standard method, from its provisions. b For the characteristic pollutants, see the pollutants listed in GB 14554 and GB 16297, according to the pollutant discharge (control) standard implemented by the pollutant discharge permit, Environmental impact assessment documents and approval and other relevant environmental management requirements, as well as the production process, raw and auxiliary materials, intermediate and final products, identified with Body pollutants project. To be released after the release of pharmaceutical industry standards for atmospheric pollutants, from its provisions. Local emission standards are required, according to strict Grid implementation. 5.2.2 Unorganized exhaust emission monitoring points, monitoring indicators and monitoring frequency Monitoring points and minimum monitoring frequency of unorganized emission monitoring sites are implemented according to Table 3. Table 3 Monitoring sites for unorganized emissions, monitoring indicators and minimum monitoring frequency Monitoring point monitoring indicators monitoring frequency Volatile organic compounds factory a, odor concentration, characteristics of pollutants b half a year Note. a According to the characteristics of the industry and environmental management needs, volatile organic compounds may choose to quantitatively sum up the main VOCs species Total organic Compounds, or non-methane organic compounds by the method of calibrating the reference material and detecting the comprehensive response of the detector to the VOCs in the mixed sample. Because at this stage the country has not yet introduced a standard test method, this standard temporary use of non-methane hydrocarbons as a comprehensive control of volatile organic compounds emissions Indicators, to be released after the relevant standard method, from its provisions. 5b For the characteristic pollutants, see the pollutants listed in GB 14554 and GB 16297, according to the pollutant discharge (control) standard implemented by the pollutant discharge permit, Environmental impact assessment documents and approval and other relevant environmental management requirements, as well as the production process, raw and auxiliary materials, intermediate and final products, identified with Body pollutants project. To be released after the release of pharmaceutical industry standards for atmospheric pollutants, from its provisions. Local emission standards are required, according to strict Grid implementation. 5.3 factory environment noise monitoring Site environmental noise monitoring points set should follow the principles of HJ 819, the main consideration in Table 4, the noise source in the plant area Distribution and location of sensitive points around the environment. Environmental noise at the factory site at least once a quarter of noise monitoring at night, night Sewage production units to be monitored at night noise. Surrounding sensitive points, the monitoring frequency should be raised. Table 4 Environmental noise monitoring site layout should be concerned about the main source of noise Noise source main equipment Raw material selection, pretreatment, cleaning, crushing process preparation process machinery, cleaning machinery, crushing machinery Extraction, Refining, Drying, Sterilization, Preparation Process Motor, Centrifuge, Pump, Fan, Freezer, Air Conditioning Unit, Cooling Tower Sewage treatment facilities sewage pump, aeration equipment, fans, sludge dewatering equipment 5.4 Peripheral environmental quality impact monitoring 5.4.1 Environmental Management Policy or Environmental Impact Assessment Document and its Approval (Available only after January 1,.2015 (inclusive)) Environmental Impact Assessment approved the sewage units) have a clear requirement, according to the requirements of the implementation. 5.4.2 Without clear requirements, if the sewage disposal unit deems it necessary, the surrounding surface water, seawater and soil may be monitored. Wastewater discharged directly into surface water, seawater discharge units, according to HJ/T 2.3, HJ/T 91, HJ 442 and receiving water body Environmental management requirements set monitoring sections and monitoring points; to carry out soil monitoring units of sewage, according to HJ/T 166 and soil Environmental management requirements set monitoring points. Monitoring indicators and minimum monitoring frequency are implemented according to Table 5. Table 5 Surrounding Environmental Quality Impact Monitoring Indicators and the Minimum Monitoring Frequency Monitoring frequency of target environmental monitoring indicators Surface water pH value, COD, dissolved oxygen, BOD 5, ammonia nitrogen, Total phosphorus, total nitrogen and so on Quarterly seawater pH, COD, BOD 5, dissolved oxygen, reactive phosphorus Acid salt, inorganic nitrogen and the like Six months Soil pH, dichloromethane, chloroform, acetone and other years Note. Surface water, seawater, soil specific monitoring indicators according to the production process of raw materials, products and by-products identified. 65.5 Other requirements 5.5.1 In addition to the indicators of pollutants in Tables 1 to 3 and Table 5, the indicators of pollutants in 5.5.1.1 and 5.5.1.2 should also be included in the monitoring Indicator range, and with reference to Table 1 ~ Table 3, Table 5 and HJ 819 to determine the monitoring frequency. 5.5.1.1 Permits for discharge, standards for pollutant discharge (control), environmental impact assessment documents and their approval (only Limited to January 1,.2015 (inclusive) after the approval of environmental impact assessment of the sewage unit), the relevant provisions of environmental management to be clear Seeking indicators of pollutants. 5.5.1.2 sewage units according to the production process of raw materials, production processes, intermediate and final product type, the monitoring results indeed The actual discharge of pollutants in the list of toxic and hazardous pollutants or priority control of pollutants indicators, or other toxic pollutants index. 5.5.2 The monitoring frequency of each index can meet the requirements of this standard and can be improved according to the principle of determining monitoring frequency in HJ 819 Monitoring frequency. 5.5.3 involved in chemical synthesis, fermentation and extraction of two or more types of industrial units of the sewage, monitoring programs should be covered All monitoring indicators for the type of industry involved are monitored with strict frequency of implementation. 5.5.4 Sampling methods, monitoring and analysis methods, monitoring of quality assurance and quality control in accordance with the relevant requirements of HJ 819 implementation. 5.5.5 Description of the monitoring program, change in accordance with HJ 819 regulations.

6 Information Recording and Reporting

6.1 Information Recording 6.1.1 Monitoring information record Manual monitoring records and automatic monitoring of maintenance records in accordance with HJ 819 regulations. 6.1.2 Production and pollution control facilities health information records The pollutant discharge unit shall record in detail the operation status of its production and pollution control facilities and record the following in daily production Related information, and organize into account for future reference. 6.1.2.1 Production health records According to the drug production batch records the following relevant information. a) raw material selection and pretreatment, cleaning, crushing Production process. record water intake (fresh water), the main raw materials (people Body, plant, animal, marine life) usage, etc .; b) extraction process. record the amount of solvent usage and crude drug production; c) Refining process. record the amount of activated carbon, carbon fiber filter, resin and other filters and carriers, inorganic salts (sodium chloride, Ammonium sulfate, magnesium sulfate, sodium sulfate, sodium phosphate, etc.), solvents (hydrochloric acid, ethanol, acetone, trichloromethane, Methane, ethyl acetate, etc.) usage and so on. 6.1.2.2 Solvent Recovery Operating Record According to the production batch record of each product name of the solvent, the amount recovered, the amount of replenishment, as well as solvent recovery equipment energy, supplies use Volume and so on. 76.1.2.3 Records of the operation of sewage treatment facilities Daily record of sewage treatment capacity, emissions, back to the amount of water, reuse, sludge production (record moisture content), sewage The name and amount of medicament used, the amount of air blower and so on; record the operation, failure and maintenance of sewage treatment facilities. 6.1.2.4 Exhaust gas treatment facility health records Record the name and amount of consumables, such as the adsorbent and filter material used for exhaust gas treatment on a daily basis, record the exhaust gas treatment facilities Line parameters, fault and maintenance conditions. 6.1.3 General Industrial Solid Waste and Hazardous Waste Information Records According to the daily record of general industrial solid waste production, comprehensive utilization, disposal capacity, storage; according to the hazardous waste pipe According to the relevant requirements, the daily record of hazardous waste production, comprehensive utilization, disposal capacity, storage and its specific whereabouts. The situation of raw materials or other hazardous wastes generated in auxiliary processes should also be recorded. General industrial solid waste and hazardous waste generation The situation is shown in Table 6. Table 6 Sources of General Industrial Solid Waste and Hazardous Waste The main type of source name General industrial solid waste Raw material selection, pretreatment, crushing, cleaning Process Sundries in raw materials, waste packaging materials, spoiled animals or the sea Biological cadaver, connective tissue or adipose tissue removed from animal tissue Weaving and so on Hazardous Waste Extraction, refining, organic solvent recovery, waste Gas treatment process Residual liquid, waste filter (filter) and other adsorption filter and carrier, Bacteria waste, waste drugs, waste reagents, waste catalyst, waste residue Note. Sludge of sewage treatment facilities (stations) and other hazardous wastes that may be produced shall be disposed in accordance with the "National Catalog of Hazardous Wastes" or the hazardous wastes stipulated by the state Identification criteria and identification methods identified. 6.2 Information Report, Emergency Report, Information Disclosure Information report, emergency report and information disclosure in accordance with HJ 819 regulations.

7 others

The pollutant discharging entity shall faithfully record the working conditions during the manual monitoring (including the production load and the operation of pollution control facilities, etc.) Ensure monitoring data is representative. This standard specifies the content, the other content in accordance with HJ 819 regulations.

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