GB 37823-2019Emission standard of air pollutants for pharmaceutical industry (English PDF)

Foreword

To implement the Law of the People's Republic of China on Environmental Protection and the Law of the People's Republic of China on Prevention and Control of Atmospheric Pollution

The quality of the environment, promote the technological progress and sustainable development of the pharmaceutical industry, and develop this standard.

This standard specifies the requirements, monitoring, supervision and management requirements for air pollutant emission control in the pharmaceutical industry.

The discharge of water pollutants, odorous pollutants and environmental noise in pharmaceutical industrial enterprises or production facilities shall be subject to the corresponding national pollutant discharge standards.

The identification, treatment and disposal of solid wastes shall be subject to the corresponding national solid waste pollution control standards.

This standard is the first release.

Since July 1,.2019, the newly established enterprises have been controlling the emission of atmospheric pollutants according to this standard since July 1, 2020.

The implementation of the quasi-specified regulations will no longer implement the relevant provisions of the Comprehensive Emission Standards for Air Pollutants (GB 16297-1996). All places can be based on

The local environmental protection needs and economic and technical conditions shall be approved by the provincial people's government to implement this standard in advance.

This standard is the basic requirement for the control of atmospheric pollutant emissions in the pharmaceutical industry. Projects not provided by local provincial people's governments for this standard,

Local pollutant discharge standards can be formulated; for projects that have been regulated in this standard, local pollutant discharge standards that are stricter than this standard can be formulated.

Appendix A, Appendix B and Appendix C of this standard are informative annexes.

This standard is formulated by the Department of Atmospheric Environment, Department of Regulations and Standards of the Ministry of Ecology and Environment.

This standard is mainly drafted by. China Academy of Environmental Sciences, Tongji University, Hebei Academy of Environmental Sciences, Taizhou Environmental Science

Design Institute, China Chemical Pharmaceutical Industry Association.

This standard is approved by the Ministry of Ecology and Environment on April 16,.2019.

This standard has been implemented since July 1,.2019.

This standard is explained by the Ministry of Ecology and Environment.

Emission standards for air pollutants in the pharmaceutical industry

1 Scope of application

This standard specifies the requirements, monitoring, supervision and management requirements for air pollutant emission control in the pharmaceutical industry.

This standard applies to the management of atmospheric pollutants emissions from existing pharmaceutical industrial enterprises or production facilities, as well as the environment of pharmaceutical industry construction projects.

Impact assessment, environmental protection facility design, completion environmental protection acceptance, emission permit issuance and management of atmospheric pollutant emissions after commissioning.

This standard also applies to pharmaceutical intermediates for pharmaceutical production and their production facilities, as well as large drug research and development institutions and their experimental facilities.

Gas pollutant discharge management.

2 Normative references

This standard refers to the following documents or their terms. For dated references, only the dated version applies to this standard.

For undated references, the latest edition (including all amendments) applies to this standard.

GB 37822 Volatile Organic Compounds Unorganized Emission Control Standard

GB/T 4754-2017 National Economic Industry Classification

GB/T 8017 Determination of vapour pressure of petroleum products - Reid method

GB/T 13554-2008 high efficiency air filter

GB/T 14669 Determination of air quality ammonia - Ion selective electrode method

GB/T 14678 Determination of air quality hydrogen sulfide, methyl mercaptan, methyl sulfide and dimethyl disulfide - Gas chromatography

GB/T 15516 Determination of formaldehyde in air quality - acetylacetone spectrophotometric method

GB/T 16157 Determination of particulate matter in fixed pollution source exhaust gas and sampling method of gaseous pollutants

HJ/T 27 Determination of hydrogen chloride in fixed source exhaust gases - Mercury thiocyanate spectrophotometric method

HJ/T 28 Determination of hydrogen cyanide in fixed source exhaust gases isonic acid-pyrazolone spectrophotometric method

HJ/T 30 Determination of chlorine in fixed source exhaust gases - methyl orange spectrophotometric method

HJ/T 31 Determination of phosgene in fixed source exhaust gases - aniline ultraviolet spectrophotometric method

Determination of total hydrocarbons, methane and non-methane total hydrocarbons from stationary sources - Gas chromatographic method

HJ/T 42 Determination of nitrogen oxides in fixed source exhaust gases - UV spectrophotometric method

HJ/T 43 Determination of nitrogen oxides in fixed source s

HJ/T 55 Technical Guidelines for the Monitoring of Unorganized Emissions of Air Pollutants

HJ/T 56 Determination of sulfur dioxide in fixed source exhaust gases - Iodometric method

HJ 57 Determination of sulfur dioxide in fixed source pollution - Determination of sulphur

HJ 77.2 Determination of ambient air and exhaust gases - Determination of dioxins - High-resolution gas chromatography - High resolution mass spectrometry

HJ/T 397 Fixed Source Exhaust Gas Monitoring Technical Specification

HJ 533 Determination of ambient air and exhaust ammonia - Nessler reagent spectrophotometry

HJ 547 Determination of chlorine in fixed source pollution - Iodometric method

HJ 548 Determination of hydrogen chloride in fixed source of waste gas - Silver nitrate volume method

HJ 549 Determination of ambient air and exhaust gases - Hydrogen chloride

HJ 583 Determination of Benzene in Ambient Air - Solid Adsorption/Thermal Desorption - Gas Chromatography

HJ 584 Determination of Benzene in Ambient Air - Activated Carbon Adsorption/Carbon Disulfide Desorption - Gas Chromatography

HJ 604 Determination of total hydrocarbons, methane and non-methane total hydrocarbons - Direct injection - Gas chromatography

HJ 629 Determination of sulfur dioxide in fixed source pollution - Non-dispersive infrared absorption method

HJ 644 Determination of Environmental Air Volatile Organic Compounds - Sampling Tube Sampling - Thermal Desorption/Gas Chromatography - Mass Spectrometry

HJ 683 Determination of ambient aldehydes and ketones - High performance liquid chromatography

HJ 692 Determination of nitrogen oxides from fixed pollution sources - Non-dispersive infrared absorption method

HJ 693 Determination of nitrogen oxides from fixed source waste gases

HJ 732 Sampling air bag method for fixed volatile waste gas

HJ 734 Determination of Volatile Organic Compounds from Fixed Pollution Sources - Solid Phase Adsorption - Thermal Desorption/Gas Chromatography - Mass Spectrometry

HJ 759 Determination of ambient air volatile organic compounds - Tank sampling/gas chromatography - mass spectrometry

HJ 819 General Guidelines for Self-Monitoring Technical Units of Sewage Units

HJ 836 Determination of low-concentration particulate matter of fixed source pollution

HJ 944 Sewage unit environmental management ledger and discharge permit implementation report technical specification general (trial)

HJ 1012 Environmental Air and Exhaust Gases, Methane and Non-Methane Total Hydrocarbon Portable Monitors Technical Requirements and Test Methods

HJ 1013 Technical requirements and test methods for continuous pollution source non-methane total hydrocarbon continuous monitoring system

Measures for the Automatic Monitoring and Control of Pollution Sources (Order No. 28 of the State Environmental Protection Administration)

Measures for the Administration of Environmental Monitoring (Order No. 39 of the State Environmental Protection Administration)

3 Terms and definitions

The following terms and definitions apply to this standard.

3.1

Pharmaceutical industry

Pharmaceutical manufacturing (C27) specified in GB/T 4754-2017, including chemical raw material manufacturing (C271), chemical preparations

Manufacturing (C272), Chinese Herbal Pieces Processing (C273), Chinese Patent Medicine Production (C274), Veterinary Drug Manufacturing (C275), Biopharmaceutical Products Manufacturing

Manufacturing (C276), sanitary materials and medical supplies manufacturing (C277), pharmaceutical excipients and packaging materials manufacturing (C278).

3.2

Production of chemical bulk drug

Preparation of a substance or substance having a pharmaceutically active ingredient by chemical synthesis, microbial fermentation, or natural plant and animal extraction

Production activities of the compound.

3.3

Production of preparation

By mixing, processing and formulating pharmaceutically active ingredients and excipients, the production activities of various dosage forms of drugs are formed.

3.4

Production of traditional Chinese Medicine

Using medicinal plants and medicinal animals as the main raw materials, according to the National Pharmacopoeia, the production of various dosage forms of traditional Chinese medicine decoction pieces and Chinese patent medicines

activity.

3.5

Production of veterinary medicine

Drug production activities for the prevention and treatment of animal diseases.

3.6

Biopharmaceutical manufacturing

Production of biochemicals, genetically engineered drugs and vaccines using biotechnology.

3.7

Manufacturing of hygienic materials

Production activities of sanitary materials, surgical dressings and other medical products for internal and surgical use. Including surgical dressings, adhesive plasters, cotton wool, etc.

Manufacturing.

3.8

Manufacture of pharmaceutical excipients and packaging materials for production of medicinal excipients

Production activities of pharmaceutical excipients and packaging materials. It includes the manufacture of medicinal capsules such as gelatin.

3.9

Pharmaceutical intermediates

A key ingredient or product that is specifically used to produce APIs or pharmaceuticals. Including all pharmaceutical intermediates included in the pharmaceutical industry statistical system

Kind, see Appendix A.

3.10

Pharmaceutical research and development institutions

Laboratory, testing room, research and development center and other institutions engaged in experimental activities such as pharmaceutical and pharmaceutical product research and development.

3.11

Volatile organic compounds (VOCs)

An organic compound involved in atmospheric photochemical reactions, or an organic compound determined according to relevant regulations.

In characterizing the overall emissions of VOCs, total volatile organic compounds (by TVOC) can be used according to industry characteristics and environmental management requirements.

Represented), non-methane total hydrocarbons (expressed as NMHC) as a pollutant control project.

3.12

Total volatile organic compounds (TVOC)

The specified monitoring method is used to measure the individual VOCs in the exhaust gas, and add the total amount of VOCs to the individual items.

The sum of the mass concentrations of VOCs. In actual work, the results of the expected analysis should be based on 90% of the total VOCs.

Take measurements and add them.

3.13

Non-methane hydrocarbons (NMHC)

Using the specified monitoring method, the hydrogen flame ionization detector responds to the sum of gaseous organic compounds other than methane, with carbon

Quantitative meter.

3.14

Process waste process vents

Exhaust gas emitted during the pharmaceutical production process, including preparation, synthesis, extraction, crystallization, centrifugation, filtration, drying, refining, packaging,

Process exhaust such as solvent recovery, and auxiliary equipment such as vacuum pump exhaust.

3.15

Fermentation tail gas from fermentation

In the production process of fermenting chemical raw materials, the waste gas containing biological metabolites discharged from the microbial fermentation tank also includes fermenter cleaning,

Vapor-containing vapor that is discharged outward during the disinfection process.

3.16

Unorganized emission

Air pollutants do not pass through the irregular discharge of the exhaust pipe, including open workplaces, and through gaps, vents, and open

Discharge of doors and windows and similar openings (holes).

3.17

Closed/closed

Contaminants are not in contact with ambient air, or are separated from ambient air by sealing materials or sealing equipment.

3.18

Confined space

A closed area or enclosed building formed by a confined structure that blocks pollutants, workplaces, etc. from the surrounding space.

The enclosed area or closed building except for personnel, vehicles, equipment, materials entering and leaving, and the exhaust pipe and vents established according to law, the door

Windows and other openings (holes) should be kept closed at all times.

3.19

VOCs materials VOCs-containing materials

This standard refers to the raw materials, products and wastes (slag, liquid) of VOCs with a mass ratio of 10% or more, and the original organic polymer.

Auxiliary materials and waste (slag, liquid).

3.20

Volatile organic liquid

Any organic liquid that releases VOCs into the atmosphere and meets one of the following conditions.

(1) a single component organic liquid having a true vapor pressure of 0.3 kPa or more;

(2) In the mixture, an organic liquid having a true vapor pressure of 0.3 kPa or more and a total mass of 20% or more.

3.21

True vapor pressure

Saturated vapor pressure (absolute pressure) at the working (storage) temperature of the organic liquid, or steaming when the liquid mixture rate of the organic mixture is zero

The air pressure, also known as the bubble point vapor pressure, can be converted according to the corresponding measurement method such as GB/T 8017.

Note. The working (storage) temperature of an organic liquid that is operated (stored) at normal temperature is calculated as the maximum monthly mean temperature of the year.

3.22

Liquid-mounted seal

The edge of the floating roof is sealed in a sealed form immersed in the liquid surface of the storage material, also known as a liquid mosaic seal.

3.23

Mechanical shoe seal mechanical shoe seal

The metal sheet is vertically pressed against the seal on the tank wall by a spring or counterweight lever.

3.24

Double seal double seals

A two-layer sealed seal is arranged between the edge of the floating roof and the inner wall of the storage tank, which is also called a double-sealed seal. The lower seal is called a primary seal, the upper layer

The seal is called a secondary seal.

3.25

Vapor balancing system

A gas communication and balancing system is provided between the loading facility and the storage tank or between the storage tank and the storage tank.

3.26

Open recirculating cooling water system

A circulating cooling water system that circulates cooling water in direct contact with the atmosphere.

3.27

Existing enterprise existing facility

Pharmaceutical industry enterprises or production facilities that have been approved for production or environmental impact assessment documents have been completed by the date of implementation of this standard.

3.28

New enterprise new facility

The environmental impact assessment document has been approved for new construction, reconstruction and expansion of pharmaceutical industry construction projects since the implementation of this standard.

3.29

Key regions

According to the requirements of environmental protection work, the air pollution is serious, or the ecological environment is fragile, or there is a need for further improvement of the ambient air quality.

Areas where strict control of atmospheric pollutant emissions is required.

3.30

Standard state

The temperature is 273.15 K and the pressure is 101.325 kPa. The limits of atmospheric pollutant emission concentrations specified in this standard are based on standards.

The dry gas in the state is the standard.

3.31

Exhaust height

The height from the ground level of the exhaust pipe (or its main building structure) to the outlet of the exhaust pipe, in m.

3.32

Enterprise boundary

The legal boundary of the enterprise or production facility. If it is difficult to determine the legal boundary, it refers to the actual land occupation boundary of the enterprise or production facility.

4 Organized emission control requirements

4.1 New enterprises Since July 1,.2019, the existing enterprises have implemented the air pollutants discharged in Table 1 since July 1, 2020.

Release limits and other pollution control requirements.

Table 1 Air pollutant emission limits

a For the waste gas discharged from special pharmaceutical production facilities, high-efficiency air filters should be used for purification or other equivalent measures. High efficiency air filtration

The device should meet the requirements of Class A filter in GB/T 13554-2008, and the particle treatment efficiency is not less than 99.9%. Special medicines include. high sensitization such as penicillin

Sex drugs, b-lactam structure drugs, contraceptives, hormonal drugs, anti-tumor drugs, virulent microorganisms and spore products, radioactive drugs.

b According to the raw materials used by the enterprise, the production process, the products produced, the by-products, combined with Appendix B and relevant environmental management requirements, etc., the screening is determined to be included in TVOC.

Substance.

c Benzenes include benzene, toluene, xylene, trimethylbenzene, ethylbenzene and styrene.

4.2 Enterprises in key areas implement the special emission limits for air pollutants specified in Table 2 and other pollution control requirements, and the geographical scope of implementation

And the time is prescribed by the competent department of ecological environment of the State Council or the provincial people's government.

a For the waste gas discharged from special pharmaceutical production facilities, high-efficiency air filters should be used for purification or other equivalent measures. High efficiency air filtration

The device should meet the requirements of Class A filter in GB/T 13554-2008, and the particle treatment efficiency is not less than 99.9%. Special medicines include. high sensitization such as penicillin

Sex drugs, beta-lactam structure drugs, contraceptives, hormonal drugs, anti-tumor drugs, virulent microorganisms and spore products, radioactive drugs.

b According to the raw materials used by the enterprise, the production process, the products produced, the by-products, combined with Appendix B and relevant environmental management requirements, etc., the screening is determined to be included in TVOC.

Substance.

c Benzenes include benzene, toluene, xylene, trimethylbenzene, ethylbenzene and styrene.

4.3 When the initial emission rate of NMHC in the exhaust of the workshop or production facility is >=3 kg/h, the VOCs treatment facility should be configured, and the treatment efficiency should not be

Less than 80%. For key areas, when the initial emission rate of NMHC in the exhaust of the workshop or production facility is >= 2 kg/h, the VOCs should be configured.

Facilities, processing efficiency should not be less than 80%.

4.4 The exhaust gas collection and treatment system shall be operated synchronously with the production process equipment. When the exhaust gas collection and treatment system fails or is repaired, the corresponding students

The production process equipment should be stopped, and it should be put into use after the completion of the inspection; the production process equipment can not be stopped or can not be stopped in time.

Exhaust gas emergency treatment facilities should be provided or other alternative measures should be taken.

4.5 VOCs Combustion (incineration, oxidation) devices in addition to meeting the air pollutant discharge requirements of Table 1 or Table 2, also need to be in the emission of flue gas

The sulphur dioxide, nitrogen oxides and dioxins are controlled to meet the limits specified in Table 3. Use boilers, industrial furnaces, solid waste incineration

Furnace incineration treatment of organic waste gas should also meet the control requirements of the corresponding emission standards.

Table 3 Limits of atmospheric pollutant emissions from combustion units

4.6 Entering VOCs The exhaust gas of the combustion (incineration, oxidation) device needs to be supplemented with air for combustion and oxidation reaction, and measured in the exhaust pipe.

The concentration of atmospheric pollutants discharged shall be converted into the baseline emission concentration of atmospheric pollutants with a reference oxygen content of 3% according to formula (1). Using boilers,

For industrial furnaces and solid waste incinerators to incinerate organic waste gas, the reference oxygen content of flue gas is implemented in accordance with its emission standards.

4.7 The exhaust pipe height of phosgene, hydrogen cyanide and chlorine emissions shall not be less than 25m, and the height of other exhaust pipes shall not be less than 15m (for safety reasons or

Except for special process requirements, the specific height and relative height relationship with surrounding buildings shall be determined according to the environmental impact assessment document.

4.8 When performing exhaust emission combined with exhaust emission requirements of different emission control requirements, it should be monitored before the exhaust gas is mixed, and the corresponding row should be executed.

Release control requirements; if the selected monitoring position can only monitor the mixed exhaust gas, it should be according to the most stringent regulations of each emission control requirement.

Scheduled execution.

5 Unorganized emission control requirements