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HJ 611-2011

Chinese Standard: 'HJ 611-2011'
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Standard ID HJ 611-2011 (HJ611-2011)
Description (Translated English) Technical guidelines for environmental impact assessment. Pharmaceutical constructional project
Sector / Industry Environmental Protection Industry Standard
Classification of Chinese Standard Z00
Classification of International Standard 13.020
Word Count Estimation 27,257
Date of Issue 2011-02-11
Date of Implementation 2011-06-01
Quoted Standard GB 5085; GB 18218; GB 18484; GB 18597; GB/T 14848; GB/T 15190; HJ/T 2.1; HJ 2.2; HJ/T 2.3; HJ 2.4; HJ/T 14; HJ/T 25; HJ/T 164; HJ/T 166; HJ/T 169; HJ/T 176; HJ/T 338
Drafting Organization Environmental Engineering Assessment Center of Jilin Province
Regulation (derived from) Department of Environmental Protection Notice No. 10 of 2011
Summary This standard specifies the pharmaceutical construction project environmental impact assessment of the general principles, contents, methods and technical requirements. This standard applies to new construction, renovation, expansion and corporate relocation pharmaceutical construction project environmental impact assessment. Production of veterinary drugs and pharmaceutical intermediates construction project environmental impact assessment may refer to this standard.

HJ 611-2011
Technical guidelines for environmental impact assessment.Pharmaceutical constructional project
National Environmental Protection Standard of the People's Republic
Technical Guidelines for Environmental Impact Assessment Pharmaceutical Construction Project
Technical guidelines for environmental impact assessment
-Pharmaceutical constructional project
Published on.2011-02-11
2011-06-01 Implementation
Ministry of Environmental Protection released
Ministry of Environmental Protection
No. 10 of.2011
To protect the environment and prevent pollution by implementing the Environmental Protection Law of the People's Republic of China and the Law of the People's Republic of China on Environmental Impact Assessment
Dyeing, standardizing the environmental management of construction projects, and now approving the "Technical Guidelines for Environmental Impact Assessment, Groundwater Environment" and other three standards for the national ring
Environmental protection standards are issued. The standard name and number are as follows.
I. Technical Guidelines for Environmental Impact Assessment Groundwater Environment (HJ 610-2011)
III. Construction project completion environmental protection acceptance technical specification oil and gas exploitation (HJ 612-2011)
The above standards have been implemented since June 1,.2011 and published by the China Environmental Science Press. The standard content can be found on the website of the Ministry of Environmental Protection.
Special announcement.
February 11,.2011
1 Scope..1
2 Normative references..1
3 Terms and Definitions.1
4 General.3
5 Survey on the status of regional natural and social environment..6
6 Enterprise Status Survey 6
7 Engineering Analysis..7
8 Cleaner Production and Circular Economy Analysis..10
9 Environmental Quality Status Survey and Evaluation..11
10 Environmental Impact Prediction and Evaluation..12
11 Environmental Risk Assessment..12
12 Environmental Protection Measures and Technical and Economic Analysis.13
13 Total pollutant control analysis..15
14 Environmental Management and Environmental Monitoring..15
15 Environmental Impact Economic Profit and Loss Analysis.15
16 Public participation.16
17 Policy, planning conformity and rationality analysis and demonstration of site selection..17
18 Conclusion 17
19 other 17
Appendix A (Normative) Format and content of the Environmental Impact Report.18
Appendix B (informative appendix) Example of process flow chart with pollution producing nodes..21
Appendix C (informative) Multi-media environment target value estimation method 22
To implement the Environmental Protection Law of the People's Republic of China, the Environmental Impact Assessment Law of the People's Republic of China and the Environmental Protection of Construction Projects
The Regulations governing and guiding the environmental impact assessment of pharmaceutical construction projects shall be formulated.
This standard specifies the general principles, contents, methods and technical requirements for environmental impact assessment of pharmaceutical construction projects.
This standard is the first release.
Appendix A of this standard is a normative appendix, and Appendix B and Appendix C are informative appendices.
This standard was formulated by the Science and Technology Standards Department of the Ministry of Environmental Protection.
This standard is mainly drafted by. Jilin Province Environmental Engineering Evaluation Center and PetroChina Northeast Refining & Chemical Engineering Co., Ltd.
This standard was approved by the Ministry of Environmental Protection on February 11,.2011.
This standard was implemented on June 1,.2011.
This standard is explained by the Ministry of Environmental Protection.
Technical Guidelines for Environmental Impact Assessment Pharmaceutical Construction Project
1 Scope of application
This standard specifies the general principles, contents, methods and technical requirements for environmental impact assessment of pharmaceutical construction projects.
This standard is applicable to the environmental impact assessment of pharmaceutical construction projects for new construction, reconstruction, expansion and enterprise relocation.
The environmental impact assessment of construction projects for the production of veterinary drugs and pharmaceutical intermediates can be carried out in accordance with this standard.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. Valid versions of undated references
Applicable to this standard.
GB 5085 Hazardous Waste Identification Standard
GB 18218 Identification of major hazard sources of hazardous chemicals
GB 18484 Hazardous Waste Incineration Pollution Control Standard
GB 18597 Hazardous Waste Storage Pollution Control Standard
GB/T 14848 Groundwater Quality Standard
GB/T 15190 Urban area environmental noise applicable area division technical specification
HJ/T 2.1 Technical Guidelines for Environmental Impact Assessment
HJ 2.2 Technical Guidelines for Environmental Impact Assessment Atmospheric Environment
HJ/T 2.3 Technical Guidelines for Environmental Impact Assessment Surface Water Environment
HJ 2.4 Environmental Impact Assessment Technical Guidelines Acoustic Environment
HJ/T 14 Environmental Air Quality Functional Area Division Principles and Technical Methods
HJ/T 25 Industrial Enterprise Soil Environmental Quality Risk Assessment Benchmark
HJ/T 164 Groundwater Monitoring Technical Specification
HJ/T 166 Technical Specifications for Soil Environmental Monitoring
HJ/T 169 Technical Guidelines for Environmental Risk Assessment of Construction Projects
HJ/T 176 Technical Specifications for Construction of Hazardous Waste Centralized Incineration Disposal Project
HJ/T 338 Technical specification for division of drinking water source protection zones
National Directory of Hazardous Wastes (Order No. 1 of the Ministry of Environmental Protection)
"Catalogue of Classified Management of Environmental Impact Assessment of Construction Projects" (Order No. 2 of the Ministry of Environmental Protection)
Interim Measures for Public Participation in Environmental Impact Assessment (Huanfa [2006] No. 28)
3 Terms and definitions
The following terms and definitions apply to this standard.
Drugs pharmaceuticals
Refers to the production approved by the drug regulatory authority of the State Council for the prevention, diagnosis and treatment of human diseases, and the purposeful regulation of human physiology
Functional and prescribed substances with adaptive or functional indications, usage and dosage.
Pharmaceutical intermediate
Refers to chemical raw materials or chemical products used in the process of drug synthesis.
Veterinary drug
Refers to substances used to prevent, treat, diagnose, or purposefully regulate the physiology of animals.
Active pharmaceutical ingredient, API
Refers to the production of the active ingredients and active ingredients approved by the drug regulatory department of the State Council, which constitutes a part of the raw materials of the drug.
Chemical synthesis
The production process of chemical or chemical raw materials by chemical reaction of organic or inorganic substances.
Biochemical products manufacturing biological pharmacy
The use of organisms and biological life activities to manufacture pharmaceutical products, including fermenting pharmaceuticals, extracting pharmaceuticals, and biotechnology pharmaceuticals.
Fermentation pharmacy refers to the production of medicines through the process of fermentation, filtration and purification of organic raw materials through the life activities of microorganisms.
Extraction of pharmaceuticals refers to the use of physical, chemical, and biochemical methods to extract active substances that play an important physiological role in living organisms.
Separation, purification and other means to produce a pharmaceutical production process.
Biotechnology pharmacy refers to the use of microorganisms, parasites, animal toxins, biological tissues, etc., using modern biotechnology (mainly genes)
Engineering technology, etc.) The production process of peptides and protein drugs, vaccines, etc.
Simple drug dispensing and compounding pharmaceuticals subpackage and compounding
By mixing, processing and formulating, the pharmaceutically active ingredients and excipients are made into a process for the production of a dosage form.
Chinese medicine decoction pieces processing and Chinese patent medicine manufacturing pharmacy of traditional Chinese medicine decoction pieces and
Traditional Chinese patent medicine
Taking medicinal plants and medicinal animals as the main raw materials, according to the Chinese Pharmacopoeia, the pharmaceutical process of Chinese herbal medicine pieces and Chinese patent medicines is produced.
Pharmaceutical construction project
Refers to the manufacture of chemical drugs, the manufacture of biochemical products, the dispensing and compounding of simple drugs, the processing of Chinese herbal medicines and the manufacture and matching of proprietary Chinese medicines.
Set of construction projects.
Pharmacy manufacturing enterprise
Pharmaceutical and API manufacturing companies.
Production workshop
A unit of a pharmaceutical production enterprise that produces medicines and APIs consisting of production equipment.
Production plant
A combination of one or more interrelated production process units.
Process unit
Within the production unit, a combination of equipment, piping and instrumentation for a relatively independent production or operation process can be completed according to the process flow.
Auxiliary facility
Water, electricity, steam and other facilities, storage and transportation facilities in the pharmaceutical company, independent of the environmental protection facilities and office facilities of the production workshop
Heat processing with supplementary materials
Refers to the preparation of medicinal materials through net processing, cutting, and cannon processing to produce a certain size of decoction pieces to meet the medical requirements and the needs of blending and preparation.
Ensure that medications are safe and effective. Commonly used methods of cannoning are. frying, hot, calcining, carbon, steaming, boiling, stewing, single, wine, vinegar, salt,
Ginger juice, candied fruit, oil sputum, frosting (de-oiling into frost), water flying, sputum.
Environmental factor
Various natural and artificially modified natural factors, including. atmosphere, water, land, mineral deposits, forests, grasslands, wild animals
Things, natural monuments, cultural relics, nature reserves, scenic spots, cities and villages.
Environmental sensitive area
Refers to the protection of all levels and types of nature and culture established in accordance with the law as stipulated in the Catalogue of Classified Management of Environmental Impact Assessment of Construction Projects.
And areas that are particularly sensitive to certain types of pollution factors or ecological impact factors in pharmaceutical construction projects.
4 General
4.1 Environmental Impact Assessment Work Classification
4.1.1 According to the provisions and requirements in the “Catalogue of Classified Management of Environmental Impact Assessment of Construction Projects”.
Environmental impact report for chemical manufacturing and bio-chemical product manufacturing construction projects, and preparation of Chinese patent medicine manufacturing construction projects with refining process
The environmental impact report form for the preparation of traditional Chinese medicine decoction pieces, the manufacture of proprietary Chinese medicines without refining process, and the preparation of simple drug packaging and compounding projects.
4.1.2 The regional environmental impact assessment or related planning environmental impact assessment work has been carried out in the area where the pharmaceutical construction project is located, including
Specific pharmaceutical construction projects, under the premise that the regional environmental quality status has not changed significantly and the regional pollution sources have not increased significantly, the environment
The topics such as environmental quality survey and evaluation and environmental impact prediction in impact assessment work can be appropriately simplified. Evaluation focuses on pharmaceutical construction projects
Engineering analysis, environmental protection measures, clean production analysis and environmental impact assessment of characteristic pollutants, etc.
The conformity of price or planning environmental impact assessment requirements and the compatibility of regional environmental resource carrying capacity.
4.2 Environmental Impact Assessment Work Procedures
The environmental impact assessment work procedures for pharmaceutical construction projects shall be carried out in accordance with the provisions of HJ/T 2.1, HJ 2.2, HJ/T 2.3, and HJ 2.4.
4.3 Environmental Impact Factors and Evaluation Factors
4.3.1 Environmental impact factors. The factors affecting the environment during the construction and operation of pharmaceutical construction projects mainly include. land occupation, discharged wastewater,
Exhaust gas, noise, solid waste, etc.
4.3.2 Evaluation factor. Pharmaceutical construction project evaluation factors except conventional indicators of wastewater and exhaust pollutants [such as chemical oxygen demand (COD), ammonia nitrogen,
In addition to total phosphorus, non-methane total hydrocarbons (NMHC), malodorous gases, etc., it should also identify its characteristic pollution factors according to the characteristics of the production process of pharmaceutical construction projects.
Son to determine the evaluation factor. One of the following basic principles should be used as an evaluation factor.
a) Limit emissions in national or local regulations and standards;
b) control of total national or local pollutant emissions;
c) including the Convention on Persistent Organic Pollutants (POPs);
d) having "three-way" toxicological properties;
e) having a characteristic characteristic of a bad odor;
f) Project environmental impact characteristic pollutants.
4.4 Environmental function zoning and evaluation criteria
4.4.1 Environmental function zoning. The list of the drawings shows the environmental function zoning and protection zone planning requirements of the town where the pharmaceutical construction project is located.
4.4.2 Evaluation criteria. It mainly includes national or local environmental quality standards, national or local pollutant discharge standards and other relevant standards;
The principle of the evaluation criteria is that the local standards are preferred, followed by the national standards, and again the reference standards.
a) According to the requirements of the urban environmental function zoning of the pharmaceutical construction project, implement the corresponding environmental quality standards and pollutant discharge standards.
b) The environmental function zone has not been demarcated, and the environmental function zone standard is determined according to the requirements of HJ/T 14, GB/T 15190 and HJ/T 338.
c) When there are no national or local environmental protection standards for pollutants in pharmaceutical construction projects, refer to the importing country of pharmaceutical construction projects or
Introduce relevant standards of the region; if there is no reference value, it can be estimated according to the multi-medium environmental target value (MEG) according to the toxicological index.
The law (see Appendix C) calculates and proposes environmental management recommended control limits.
d) The evaluation criteria shall be confirmed in writing by the relevant environmental protection administrative department.
4.5 Evaluation work level
4.5.1 Atmospheric, surface water, acoustic environmental assessment level. Performed in accordance with the provisions of HJ 2.2, HJ/T 2.3 and HJ 2.4 respectively.
4.5.2 Groundwater and soil environmental assessment grades. Survey or monitor the status of groundwater and soil that may be affected by pharmaceutical construction projects only,
And develop environmental protection measures and follow-up monitoring plans.
4.5.3 Environmental risk assessment level. Perform as specified in HJ/T 169.
4.6 Evaluation scope and environmentally sensitive targets
4.6.1 Evaluation scope Scope of assessment of atmospheric, surface water and acoustic environment. Performed in accordance with the provisions of HJ 2.2, HJ/T 2.3 and HJ 2.4 respectively. Scope of investigation of groundwater and soil environment. The hydrogeological conditions of the proposed site, the permeability coefficient of the soil, and the site should be considered comprehensively.
Near the groundwater environment sensitive target distribution, etc., the scope of investigation of groundwater status is reasonably determined. The scope of the survey is determined as the perimeter of the plant
Within the scope of the groundwater, the groundwater range that may be affected by the pharmaceutical construction project may be appropriately adjusted.
The scope of the soil current survey is determined by the scope of the plant and the extent to which it may be affected outside the plant. Scope of environmental risk assessment. Perform as specified in HJ/T 169.
4.6.2 Environmentally sensitive targets
The attached table describes the environmental function categories or levels of various environmental factors within the scope of evaluation, the sensitive protection objectives and functions of each environmental factor and their systems
The relative position and distance of the drug construction project.
4.6.3 Drawing requirements
A color map of the evaluation range of the wind rose diagram and the environmentally sensitive target is attached, and the scale is indicated.
a) The atmospheric environmental impact assessment scope map shall indicate the ambient air monitoring point;
b) The surface water environmental impact assessment scope map shall indicate the monitoring section, water flow direction, surface runoff inlet and sewage discharge port;
c) The groundwater environmental impact assessment scope map shall indicate the monitoring point and groundwater flow direction;
d) The soil environmental impact assessment scope map should indicate the soil monitoring point;
e) The environmental risk assessment scope map should indicate the environmentally sensitive area;
f) The general layout plan of the plant area shall indicate the noise monitoring point.
4.7 Thematic settings
4.7.1 For pharmaceutical construction projects that require an environmental impact report, the environmental impact assessment work should generally set the evaluation topics listed in Table 1.
a) If the construction unit of the new project is newly established within the scope of evaluation, there may be no survey on the status quo of the enterprise;
b) Survey of groundwater environmental quality status and survey of soil environment status can be based on project pollution and emission characteristics, site selection and environmental sensitivity
The degree of sensation is determined whether it is set;
c) The sewage generated by the pharmaceutical construction project is discharged into the sewage treatment plant in use and its treatment process and processing capacity can meet the pharmaceutical construction project.
The topic of surface water environmental impact prediction and evaluation can be simplified when needed;
d) Biotechnology pharmaceutical projects can visualize the pollution and emission characteristics of the project, and the environmental sensitivity of the site selection does not have atmospheric and acoustic environmental impacts.
Forecast and evaluation, environmental risk assessment topics.
Table 1 List of the special settings for environmental impact assessment of pharmaceutical construction projects
Serial number topic name setting requirements
1 Status of regional natural and social environment**
2 Enterprise Status Survey*
3 Engineering Analysis**
4 Cleaner Production and Circular Economy Analysis**
5 Environmental Quality Status Survey and Evaluation**
5.1 Survey and evaluation of current environmental air quality**
5.2 Survey and evaluation of current status of surface water environment**
5.3 Survey on the status of groundwater environmental quality*
5.4 Investigation and evaluation of the current status of acoustic environment **
5.5 Survey of soil environment status*
6 Environmental Impact Prediction and Evaluation**
6.1 Atmospheric Environmental Impact Prediction and Evaluation*
6.2 Prediction and evaluation of surface water environmental impact*
6.3 Acoustic environmental impact prediction and evaluation*
7 Environmental Risk Assessment*
8 Environmental Protection Measures and Technical and Economic Feasibility Analysis**
9 Total pollutant control analysis**
10 Environmental Management and Environmental Monitoring**
11 Environmental Impact Economic Profit and Loss Analysis**
12 Public participation**
13 Policy, Planning Compliance and Site Selection Rationality Analysis and Argumentation**
Note. ** must be set;
* According to the contents of the pharmaceutical construction project and the environmental characteristics of the development area, select the settings according to the provisions of a) to d).
4.7.2 The pharmaceutical construction projects that prepare the environmental impact report form can be set up according to the specific conditions, such as engineering analysis and environmental protection measures.
Line evaluation.
5 Survey of regional natural and social environment
5.1 Survey content
Focus on the following to understand.
a) Overview of the natural environment. Including geology, geomorphology, meteorology, climate, hydrology, hydrogeology, surrounding natural remains and nature reserves
Distribution of the situation, etc.
b) Overview of the social environment. Including the economic development of the region, the number of residential areas and population, the scale of enterprises and institutions, and the relative
The orientation and distance of pharmaceutical construction projects, and the distribution of related cultural relics protection sites.
c) Regional pollution sources. The survey was conducted in accordance with HJ 2.2 and HJ/T 2.3.
d) Environmental function zoning and ecological function zoning.
5.2 Survey method
On-site inspections, visits by relevant departments, collection of existing data and maps (such as water system maps, land use maps, environmental function maps, etc.).
5.3 Drawing requirements
Attached to the geographical location map of the pharmaceutical construction project, the regional location map of the pharmaceutical construction project, the distribution map of the environmentally sensitive area, etc., can use the 4.6.3 rules
The drawings are given.
6 Enterprise Status Survey
6.1 Survey scope
The scope of the investigation includes the production equipment and auxiliary facilities belonging to the construction unit and located in the same area as the pharmaceutical construction project.
It shall include the total amount of pollutants discharged by the construction unit covered by the environmental protection administrative department.
6.2 Survey content
6.2.1 Basic overview of the company
Including the production workshop (or installation) of the enterprise, the auxiliary facilities; the product types and production methods of each production workshop (or installation),
Production scale; product type and output during the evaluation period, types of raw materials and auxiliary materials used and their consumption; production workshops during the evaluation period (or
Equipment, and auxiliary facilities, water, electricity, steam and other public works.
6.2.2 Utilization of water resources
Including the water supply and drainage conditions, water supply and drainage balance map or table in the production workshop (or installation) and auxiliary facilities during the evaluation period.
Calculate the water reuse rate of the enterprise and explain its water use level.
6.2.3 Analysis of pollution sources Exhaust gas emissions. Investigate the exhaust emissions (m3/h) of each exhaust pipe or chimney, and the mass concentration of major pollutants.
(mg/m3) and rate (kg/h), exhaust pipe or stack height (m), inner diameter (m), exhaust temperature (°C), exhaust emission law (continuous
Or intermittent; intermittent discharge, to give the number of discharges per unit time, each duration); unorganized emission characteristics and pollution
The total annual discharge (t/a) and the concentration of characteristic pollutants at the monitoring point of the plant boundary (mg/m3);
Put the situation. Wastewater discharge. Investigate the division of the drainage system of the enterprise, and whether the drainage system of the enterprise can achieve the separation of rain and sewage, and clearing and diverting the sewage.
Understand and explain the discharge of waste water from the production workshop (or installation) and auxiliary facilities, the amount of waste water discharged from the enterprise, and the final destination of the discharge at the outlet.
Wastewater discharge (m3/d) for each workshop (or installation) and ancillary facilities, mass concentration (mg/L) of major pollutants, waste
The law of water discharge (continuous or intermittent; intermittent discharge, depending on the actual production situation of the plant or workshop, giving the number of discharges per unit time,
Every time duration) and emissions go.
Wastewater discharge (m3/d) of the wastewater discharged from the enterprise, the mass concentration of the main pollutants (mg/L), and the discharge standard
Quasi-analytical compliance emissions. Solid waste discharge. Investigate the name, source, amount, main components and content of solid waste, according to the National Hazard
The Waste List requires classification and numbering. For those not listed in the list, it is identified according to GB 5085 to determine whether it is hazardous waste. Genus
Hazardous wastes identify their hazardous characteristics and where they ultimately go. Noise emission. The actual measurement of the environmental noise value of the enterprise boundary is based on actual measurement.
6.2.4 Environmental protection measures
Exhaust gas and wastewater treatment facilities mainly investigate the scale, actual treatment volume and process method, actual operation effect (import and export indicators,
Removal efficiency), can guarantee stable operation and meet the standard discharge.
If the enterprise wastewater is entrusted to other units for treatment, the scale, actual treatment volume and process method of the wastewater treatment facilities of the entrusted unit shall be investigated.
Actual operation results (import and export indicators, removal efficiency), discharge standards, and analysis of whether the entrusted unit has the ability to receive and process.
The investigation of solid waste treatment and disposal measures includes the following contents. construction indicators of storage facilities, classified storage, and specification of packaging.
Process design requirements and operation conditions of comprehensive utilization, incineration and landfill facilities, and analysis of compliance with relevant regulations, standards, and technical requirements;
Whether the unit that entrusts the enterprise solid waste is qualified and capable of receiving and processing, and whether the implementation of hazardous waste account management and transfer orders
And other systems.
6.2.5 Environmental Management and Environmental Monitoring
The establishment and operation of the environmental management organization of the enterprise, and the establishment and operation of the environmental management system.
The establishment and staffing of the enterprise environmental monitoring agency, equipped with the main sampling and analytical instrument equipment model and quantity.
The monitoring plan includes the monitoring points of the pollution source (including the plant boundary), the monitoring items, and the frequency of monitoring, indicating whether the monitoring plan meets the relevant standards.
6.2.6 Investigation of projects under construction
Mainly investigate the name of the project under construction, product plan and scale, production methods, consumption of raw and auxiliary materials and public works, “three wastes” emissions and
The implementation of the standards, the total amount of pollutants discharged, environmental protection measures and the approval of the EIA report.
6.2.7 Accounting of total pollutant discharge of enterprises
Based on the above survey, the annual production of water pollutants, atmospheric pollutants and solid wastes in the production period, including projects under construction, is calculated.
Volume, total reduction and total emissions.
6.2.8 Analysis of existing environmental problems in enterprises
Through the above investigation, analyze the existing environmental problems or pollution hazards of the enterprise.
6.3 Survey method
Collect the company's existing production, design materials and related operational procedures, and investigate the company's profile and water use.
Collect the existing pollution source monitoring data, pollution source census statistical data, or use the design data to take material balance,
The “discharge” is investigated and the key sources of pollution are monitored as necessary.
Collect enterprise monitoring data, design materials and relevant data of the commissioned processing units to investigate environmental protection measures.
7 Engineering Analysis
7.1 Analysis content
The engineering analysis of pharmaceutical construction projects should mainly include the following nine aspects. The reconstruction and expansion projects shall be in accordance with 7.1.4 to 7.1.6.
The requirements of 7.1.9 describe the changes. The relocation project shall explain the changes in accordance with the requirements of 7.1.1~7.1.6 and 7.1.9.
7.1.1 Project Overview
Including the project name, construction nature, construction site, total investment, project composition, production scale, product plan, annual operation hours, and
Staff, floor space, floor plan (with general layout plan), main technical and economic indicators.
For pharmaceutical construction projects produced in batches, in addition to the annual operating hours, the annual production batch, the production cycle per batch, and
Number of running batches, etc.
7.1.2 Main raw and auxiliary materials and fuel
Introduce the specifications, sources, uses, consumption, maximum use of production sites, storage and transportation methods, and storage sites
Storage, fuel type, composition and content, consumption, etc.
7.1.3 Public works
In addition to introducing water, drainage, steam, heating, power supply, ventilation and other projects, we should also introduce pure water preparation systems and air purification systems.
Explain whether the discharged air is recycled.) Public utilities such as refrigeration systems are unique to the pharmaceutical industry.
7.1.4 Process principle
Analyze and explain the main process principles, technical routes and their sources, and clarify the chemical molecular structure of the main and by-products. Chemical manufacturing
List the main and secondary chemical reaction equations, indicating the reaction conversion rate, product yield, and so on. Fermentation in the manufacture of biochemical products gives products
Rate and other indicators.
7.1.5 Balance analysis
According to the principle of the process and the characteristics of production, the material balance analysis and summary of each production unit of the pharmaceutical construction project is given, and the input and output are given.
Ratio, material loss rate.
Solvent balance analysis should be performed on pharmaceutical construction projects that use solvents. Explain the solvent recovery process, and select and recycle process conditions from equipment
The feasibility of the process is demonstrated in terms of the process, and the recovery rate and whereabouts of the solvent are clarified.
Toxic and hazardous substances or the main chemical elements thereof should be analyzed for flow balance and analyzed for their final flow direction and form of existence.
Analyze the water balance of pharmaceutical construction projects and enterprises, and give the amount of fresh water, the amount of repeated water, the amount of wastewater generated, the amount of treatment,
Re-use and final external discharge, clear specific reuse sites, calculate water reuse rate, wastewater reuse rate, etc.
Line analysis.
The above balance analysis should give a balance diagram and a balance diagram.
7.1.6 Analysis of process flow, pollution production and pollution source emission Process flow and pollution production. Analyze and describe the process flow according to the production unit (or process unit), including raw material configuration, raw
Production, product packaging, pollutant treatment, etc., as well as material transfer and material recovery in the intermediate process. Explain the location and method of material feeding, materials
Trend, main operating conditions, product and pollutant discharge locations, contaminant destination, material reuse and application. Pay attention to the raw and auxiliary materials and
Analysis of characteristic pollution factors produced by intermediate reaction processes.
The process flow chart with the pollution producing node is given. The process flow chart is composed of the main production or operation steps in the process unit, and the process flow chart should be
The key items reflect the main material flow direction, the pollution production node (ie, the pollution source), and the classification number of the pollution generation node is consistent with the process flow description.
See Appendix B for an example of a process flow diagram for a contaminated node.
At the same time, the storage and transportation process, public works facilities, etc. are analyzed. Analysis of pollution source emissions. According to the process principle and process, analyze the main pollutants discharged by the pollution source, and give the pollution source
The levy table, the pollution source number in the table corresponds to the process flow chart.
a) The exhaust gas pollution source emission characteristics table shall include. the name of the pollution source, the location of the equipment, the number, and the emission of the exhaust gas (m3/h or m3/d),
Pollutant name, pollutant concentration (mg/m3), pollutant discharge rate (kg/h), emissions.
Related standard:   HJ 616-2011  HJ 617-2011
Related PDF sample:   HJ 630-2011  GB/T 32355.5-2015
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