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HJ 792-2016: Technical guidelines for environmental protection in pharmaceutical constructional project for check and accept of completed project
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Technical guidelines for environmental protection in pharmaceutical constructional project for check and accept of completed project
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Basic data | Standard ID | HJ 792-2016 (HJ792-2016) | | Description (Translated English) | Technical guidelines for environmental protection in pharmaceutical constructional project for check and accept of completed project | | Sector / Industry | Environmental Protection Industry Standard | | Classification of Chinese Standard | Z05 | | Word Count Estimation | 38,327 | | Date of Issue | 2016-03-29 | | Date of Implementation | 2016-07-01 | | Quoted Standard | GB 3096; GB 5468; GB 8978; GB 12348; GB 16297; GB 18597; GB 18599; HJ 2025; HJ/T 55; HJ/T 91; HJ/T 92; HJ/T 194; HJ/T 373; HJ/T 397; HJ 493; HJ 494; HJ 495; HJ 630 | | Regulation (derived from) | Ministry of Environmental Protection Announcement No | | Issuing agency(ies) | Ministry of Ecology and Environment | HJ 792-2016: Technical guidelines for environmental protection in pharmaceutical constructional project for check and accept of completed project
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Technical guidelines for environmental protection in pharmaceutical constructional project for check and accept of completed project
National Environmental Protection Standard of the People 's Republic of China
Technical specification for acceptance of environmental protection for construction project completion
Pharmaceuticals
Technical guidelines for environmental protection in pharmaceutical constructional
Project for check and accept of completed construction project
2016-3-29 released
2016-7-1 implementation
Ministry of Environmental Protection released
Directory
Foreword
1. Applicable scope 2
2. Normative references 2
3. Terms and definitions
4. General
5. Technical requirements for acceptance phase
6. Preparation of acceptance of technical programs
7. Implementation of acceptance technology program
8. Preparation of Acceptance Technical Report
Appendix A (Normative Appendix) Acceptance Technical Program, Report Layout and Content
Appendix B (informative appendix) Acceptance technical program, report example Figure 22
Appendix C (informative) Acceptance Technical Program, Report Reference Table 32
Foreword
To implement the "Environmental Protection Law of the People's Republic of China", "Environmental Impact Assessment Law of the People's Republic of China", "Construction Project Environmental Protection Management
Regulations, "the implementation of the" completion of the construction project environmental protection acceptance management approach "to protect the ecological environment, standardize the construction of pharmaceutical projects completed environmental protection
Inspection and acceptance work, the development of this standard.
This standard specifies the working procedures, general requirements, acceptance technical scheme and acceptance technology for the completion of environmental protection acceptance technology for pharmaceutical construction projects.
Report preparation requirements.
Appendix A to this standard is a normative appendix, Appendix B, Appendix C is an informative appendix.
This standard is the first release.
This standard is organized by the Ministry of Environmental Protection Science and Technology Standards Division.
The drafting of this standard. Nanjing Environmental Monitoring Center Station.
This standard is approved by the Ministry of Environmental Protection on March 29,.2016.
This standard has been implemented since July 1,.2016.
This standard is explained by the Ministry of Environmental Protection.
Construction project completion environmental protection acceptance technical specifications pharmaceutical
1 Scope of application
This standard specifies the working procedures, general requirements, acceptance technical scheme and acceptance of the environmental protection acceptance technology for the completion of the pharmaceutical construction project
Technical report preparation requirements.
This standard applies to the pharmaceutical production (excluding the production of pharmaceutical equipment) construction projects completed the completion of environmental protection and acceptance work. Production and construction of veterinary drugs
The completion of the project Environmental protection and acceptance work can be carried out with reference to this standard.
2 normative reference documents
The contents of this standard refer to the following documents or the terms of the following. For undated references, the valid version applies to this standard.
GB 3096 sound environmental quality standards
Test method for boiler smoke and dust
Comprehensive Emission Standard for Wastewater
Standard for Environmental Noise Discharge of Industrial Enterprises
GB 16297 Integrated Emission Standard for Air Pollutants
Standard for Hazardous Waste Storage Pollution Control
Standard for Pollution Control of Storage and Disposal Site for General Industrial Solid Waste
Determination of particulate matter and sampling method of gaseous pollutants in exhaust gas of fixed pollution sources GB/T 16157
Technical specification for storage and transportation of hazardous wastes
Technical Guidelines for Unorganized Emissions Monitoring of Air Pollutants
Technical specification for surface water and wastewater monitoring
Technical specification for monitoring total water pollutant discharge
Technical specification for manual monitoring of ambient air quality
HJ/T 373 fixed pollution source monitoring quality assurance and quality control technical specifications (Trial)
Technical specification for HJ/T 397 fixed source exhaust gas monitoring
Technical specification for preservation and management of samples of water quality SJ
Technical guidance for water quality sampling of HJ/T 494
Technical Guidance for Design of Water Quality Sampling Scheme for HJ/T 495
Technical Guidelines for Environmental Monitoring Quality Management
"Notice on the Relevant Issues Concerning the Monitoring and Management of the Acceptance and Acceptance of Environmental Protection Facilities for Construction Projects" (State Environmental Protection Administration of China)
38)
3 terms and definitions
The following terms and definitions apply to this standard.
3.1 pharmaceutical construction project
Refers to the manufacture of chemical drugs, bio-biochemical drugs manufacturing, simple drug packaging and complex, Chinese medicine Pieces processing and proprietary Chinese medicine manufacturing and with
Supporting the construction project.
3.2 mixed preparation pharmaceutical mixing/compounding and formula pharmaceutical
Refers to the use of pharmaceutical active ingredients and excipients through the mixing, processing and preparation, the formation of various formulations of drugs in the process.
3.3 extraction of pharmaceutical extraction pharmaceutical
Refers to the use of physical, chemical, biochemical methods, the organism plays an important physiological role in the extraction of various basic substances
From the purification and other means of manufacturing drugs.
3.4 fermentative pharmaceutical
Refers to the method of microbial fermentation to produce antibiotics or other active ingredients, after separation, purification, refining and other processes to produce drugs
Process, according to product categories are divided into antibiotics, vitamins, amino acids and other categories.
3.5 Chinese herbal medicine Chinese traditional pharmaceutical
Refers to the medicinal plants and medicinal animals as the main raw material, according to the National Pharmacopoeia, the production of Chinese medicine Pieces and proprietary Chinese medicine products of various formulations
Process
3.6 chemical synthesis pharmaceutical chemical synthesis pharmaceutical
Refers to the process of producing a pharmaceutically active ingredient using a chemical reaction or a series of chemical reactions.
3.7 bio-engineering pharmaceutical bio-pharmaceutical
Refers to the use of modern biotechnology methods (mainly genetic engineering technology, etc.) for production, as a treatment, diagnosis and other uses of the peptide,
Nucleic acids and protein drugs, vaccines and other drugs in the process, including genetic engineering drugs, genetic engineering vaccine.
3.8 effluent volume
Refers to the amount of wastewater discharged from a production facility or enterprise outside the legal boundary of the enterprise, including a variety of efferents that are directly or indirectly related to production
Waste water (such as plant sewage, cooling wastewater, washing wastewater, filtration wastewater, plant boilers and power plant drainage, etc.).
3.9 unit product baseline displacement benchmark effluent volume per unit product
Refers to the upper limit of the amount of waste water discharged from the production unit product specified for the determination of the concentration of water pollutants.
3.10 production conditions
Refers to the state of the production plant or facility operation, including normal production conditions and abnormal production conditions. Normal production conditions refer to production equipment
Or facilities in accordance with the design process parameters stable operation of the state. Non-normal production conditions refers to the production plant or facilities test, shutdown, maintenance or
Process conditions when the process parameters are unstable.
4 General
4.1 Acceptance requirements
4.1.1 phased construction, phased production of pharmaceutical construction projects, can be carried out in phases acceptance. For the stage of the acceptance of the construction project, the environment
The operation of the protective facility should meet the requirements of the stage.
4.1.2 The overall acceptance should be stable in the working conditions, the production load to achieve more than 75% of the design load (including 75%), the normal operation of environmental protection facilities
Effective in case. If the production load is less than 75%, is a stage acceptance.
4.2 Acceptance period and scope
4.2.1 According to the characteristics of pharmaceutical construction projects, acceptance monitoring and investigation of the time period mainly in the trial production period.
4.2.2 Acceptance technology The scope of work is in principle consistent with the scope of environmental impact assessment. When the actual project content or the environment changes, or the environment
When the impact assessment fails to fully reflect the environmental impact, the scope of work should be adjusted accordingly. When the actual construction content is subject to major changes,
Charging approval and then acceptance.
4.3 acceptance evaluation criteria
4.3.1 In principle, the evaluation criteria for the environmental impact assessment document of the construction project and the approval document in the approval document shall be used as the acceptance evaluation standard.
4.3.2 The revised or newly developed environmental quality standards, pollutant discharge standards, the use of revised or newly developed environmental quality standards, pollution
Dye emission standards as the acceptance of inspection standards.
4.3.3 The environmental impact assessment document and its approval documents are not required, refer to the current national, local and industry standards or foreign
standard.
4.3.4 At this stage there is no environmental protection standards, but the EIA report to make an assessment, should be based on the EIA report for acceptance evaluation,
If the EIA report is not evaluated, it can be analyzed according to the actual situation.
4.4 Acceptance of technical work principles and methods
4.4.1 According to the characteristics of various types of pharmaceutical construction projects closely linked to the recommendations of environmental impact assessment and approval requirements.
4.4.2 using data research, field survey, on-site monitoring and investigation methods to carry out acceptance of technical work.
4.4.3 monitoring, investigation process and the use of technical methods should be consistent with the relevant national regulatory requirements.
4.5 Acceptance of technical work procedures and content
Pharmaceutical construction projects completed environmental protection acceptance technical work, including the preparation phase, the preparation of acceptance technology program stage, the implementation of acceptance technology
Technical phase of the program and the preparation of acceptance technical report (table) stage four stages. Acceptance of technical work procedures shown in Figure 1.
Figure 1 Pharmaceutical construction project completed environmental protection acceptance technical working procedures
4.5.1 preparation phase
Data collection, analysis, site survey and so on.
4.5.2 Preparation of acceptance technology program stage
On the basis of access to relevant information, on-site investigation to determine the scope of acceptance, acceptance evaluation criteria, acceptance monitoring and acceptance survey
Capacity.
4.5.3 Implementation of acceptance technology program stage
According to the acceptance of technical programs to determine the content of the work to monitor and investigate.
4.5.4 Preparation of acceptance technical report stage
Summarize the monitoring data, check and investigate the results, analysis and evaluation concluded that the acceptance of technical reports (table) form reflects the construction items
The completion of the completion of environmental protection inspection and acceptance, the results of the survey, as the construction project completed environmental protection and acceptance of technical basis.
4.6 Acceptance of technical results and report form
Preparation of environmental impact report of the pharmaceutical project to accept the monitoring report form report monitoring and investigation results.
Preparation of environmental impact report form of the pharmaceutical project to check the form of monitoring reports to monitor and investigate the results.
Preparation Phase
Data collection, analysis site survey
Preparation of acceptance technology program
Acceptance monitoring
content
Analysis method and
Quality assurance
Environmental management
an examination
Environmental risk
survey
Public opinion
survey
Acceptance evaluation
standard
Pollution sources and
Governance measures
Project Overview
Implementation of acceptance technology program
Site monitoring
And investigation
Monitoring data and surveys
Result finishing
Preparation of Acceptance Technical Report (Table)
Monitoring results
Analysis and evaluation
Survey results
Analysis and evaluation
Monitoring conclusions
With suggestions
Technical Reports
annex
Quality control and
Quality assurance
Analysis of working conditions
5 Acceptance stage technical requirements
5.1 Data collection and analysis
5.1.1 Data collection
5.1.1.1 File report data
A) the construction project environmental impact assessment documents and environmental protection departments at all levels of the approval of the views;
B) changes in the design and construction of the construction project and the corresponding approval documents;
C) preliminary design of the construction project (environmental protection articles);
D) the construction project approval, trial production advice (except for the trial of production advice) and so on.
5.1.1.2 Profile information
Construction project location map, plant layout plan (should be marked with the main source of pollution and plant surrounding environment, drainage
Pipe network, environmental sensitive point distribution, etc.), the project location wind direction rose map, material and water balance diagram, production process and pollution generation show
Intent, pollution treatment process flow chart, the main management facilities design and so on.
5.1.1.3 Environmental management information
A) Construction unit Environmental protection organization, environmental management system;
B) Construction unit Environmental protection facilities Operation desk account; Sewage access control materials; Solid waste account, hazardous solid waste entrusted disposal
Agreement (or contract) and the qualification certificate of the entrusted party;
C) daily environmental monitoring plan;
D) the implementation of environmental risk prevention measures/facilities, emergency environmental contingency plans and filing documents;
E) documents relating to environmental sensitive points, approval documents, supporting documents and other relevant information, such as demolition certificate;
F) Environmental supervision report (EIA approval required).
5.1.2 Data analysis
The technical information collected for finishing, research, familiar with and master the following.
5.1.2.1 Construction content and scale
Including the construction of the main works, public works and environmental protection projects and the scale of the construction. Change, expansion project should be clear "to the new with the old,
Energy saving, total reduction "and other specific requirements.
5.1.2.2 Production process and pollution analysis
Including major raw and auxiliary materials, intermediate products, main products and by-products. Analyze waste gas, waste water, solid waste, noise by production process
Such as the amount of production, the main pollution factor, the corresponding supporting governance facilities, processing technology and emissions where the implementation of the focus of the scene to investigate.
5.1.2.3 Total layout of plant area
Including the plant waste, organized, unorganized emission sources, wastewater treatment unit of the device imports, exports, the total discharge of waste water, rainwater discharge,
Noise sources and other specific locations. It is planned to organize the emission of non-organized, organized emission monitoring points, waste water, rainwater discharge monitoring points, plant boundary noise monitoring
Measuring point. For the waste water into the centralized sewage treatment plant, but also need to understand the centralized sewage treatment plant acceptance, operation.
5.1.2.4 Environmental sensitive points
Including the acceptance of water bodies, atmospheric sensitive points, noise sensitive points, solid waste may cause secondary pollution protection targets, to determine whether
And the necessary environmental quality monitoring survey.
5.1.2.5 Environmental management of construction projects
Including the establishment of environmental management agencies and the establishment of environmental rules and regulations, the establishment of environmental protection monitoring stations and routine monitoring plan, solid waste
(Including environmental protection facilities, measures, monitoring equipment, etc.), and the list of environmental protection investment plans (including environmental protection facilities, measures, monitoring equipment, etc.)
Check on site.
5.2 Site survey
5.2.1 Production line survey
Pharmaceutical construction projects include chemical synthesis, extraction, fermentation, Chinese medicine, bio-engineering, mixed preparations six categories
The basic process, compound production process according to the actual situation with reference to the basic process of the corresponding sections were carried out exploration.
5.2.1.1 Chemical synthesis of pharmaceutical manufacturing process
A) Chemical synthesis
Investigation of raw material types, storage and use; storage tanks, storage area of the area, non-organized emissions; the main ingredients of the production workers
Art, the reaction process materials name and dosage, process wastewater, process waste gas, noise generation and treatment, unorganized emission sources; waste
Slag production and disposal methods; mother liquor reuse situation.
B) crude refined
Investigation of filtrate, washing wastewater production and treatment methods; drying, centrifugal process without tissue emission sources; waste adsorbent, waste activated carbon and other solid
Waste generation and treatment; acid, alkali, organic solvent recycling, mother liquor reuse situation.
5.2.1.2 Extraction of pharmaceutical production process
A) Raw material selection and pretreatment
Investigation of the type of raw materials, storage and use; raw materials packaging materials, pretreatment of waste disposal methods.
B) crushing of raw materials
Investigation of crushing methods; biochemical method of waste, crushed waste gas recovery, emissions and disposal; crushing machinery noise control measures.
C) extraction
Investigation and extraction of solvent types, storage and use; heating mode; solvent evaporation, waste water, residue emissions and treatment;
Recycling method.
D) Isolation and purification
Investigation of refined methods; solvent evaporation of waste gas, refined wastewater, residue emissions and treatment.
E) dry sterilization
Investigation of dry sterilization methods; dry exhaust emissions and treatment; air compressor and other mechanical equipment noise control measures.
5.2.1.3 fermented pharmaceutical manufacturing process
A) Fermentation
Survey product and type of raw materials, storage and use; storage area of the area, non-organized emissions; fermentation solution reuse;
Fermentation production mode, fermentation process material consumption; laboratory waste water, washing tank water, fermentation tail gas, noise generation and treatment; waste
Production and disposal methods.
B) refining
Investigation and extraction of solvent types, storage and use; heating mode; solvent evaporation, waste water, residue emissions and treatment;
Recycling method.
C) crude refined
Investigation of filtrate, washing wastewater production and treatment methods; drying, centrifugal process without tissue emission sources; waste adsorbent, waste activated carbon and other solid
Waste generation and treatment; acid, alkali, organic solvent recycling, mother liquor reuse situation.
5.2.1.4 Chinese medicine production process
A) Netting process
To investigate the type of raw materials, storage and use of materials; storage area of the site; soaking, washing wastewater production and disposal methods;
Wind generator election noise and treatment; waste herbs, impurities, drug dust production and disposal methods.
B) Cutting process
Investigation of the process requirements, the disposal of drug dust; cutting machine noise generation and treatment.
C) artillery process
Investigation fried, hot, calcined and other treatment process generated by the drug smoke treatment; waste residue and other solid waste generation and treatment.
D) extract the refining process
Investigate the types of solvent, the amount of reuse and storage, solvent evaporation of waste gas, crushing process dust emissions and treatment methods;
Non-organized sources of e...
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