HJ 1064-2019Technical specification for application and issuance of pollutant permit Pharmacy industry-Chinese traditional medicine manufacturing (English PDF)

4.1 Basic principles

The pollutant discharge unit shall fill in the corresponding information on the pollutant discharge permit platform in accordance with the requirements of this standard. Local ecological environment not included in the sewage permit platform If the competent authority in charge of the environment has a requirement to fill in the report or the polluting unit considers it necessary to fill in the report, it may add the content on its own.

Local eco-environmental authorities at or above the city level with districts may increase the need to include the content of the information is added to the management system of the pollution permit management information platform declaration system.

Content "column.

4.2 Basic information of pollutant discharge units

The basic information of the polluting unit should be filled in with the name of the unit, whether it needs to be rectified, the type of pollution permit management, postal code, and industry category (fill in at the time of report, select "Pharmaceutical Industry-Traditional Chinese Medicine Piece Processing", "Pharmaceutical Industry-Chinese Patent Medicine Production", "Pharmaceutical Industry-Veterinary Medicine System" Manufacturing-processing of traditional Chinese medicine pieces "," pharmaceutical industry-manufacturing of veterinary drugs-production of traditional Chinese medicine "), whether to put into production, the date of production, and operation the latitude and longitude of the center of the site, whether the site is an environmentally sensitive area (such as a key atmospheric control area, a total nitrogen and total phosphorus control area, etc.), is it located in the name of the industrial park, the affiliated industrial park, the construction project environmental impact assessment document approval opinion document number (recording number), document number of the regulatory project, document number of main pollutant total distribution plan, total particulate matter index (t/a), sulfur dioxide Total indicator (t/a), Total nitrogen oxides indicator (t/a), Total volatile organic compounds indicator (t/a), Total chemical oxygen demand indicator (t/a), Total ammonia nitrogen indicator (t/a), total other pollutant indicators (if any) involved, etc.

4.3 Major Products and Capacity

4.3.1 General principles

The main production unit name, main process name, production facility name, production facility number, facility parameters, product name, Production capacity, measurement unit, design annual production time and others. The following "4.3.2 ~ 4.3.7" are required and "4.3.8" are optional.

4.3.2 Main production units, main processes and production facilities

Refer to Table 1 for the contents of the main production units, main processes and production facilities of the pollutant discharge unit. Pollutant discharge units need to fill for main processes and production facilities, you can select "Other" in the declaration system to fill in.

Table 1 List of main production units, main processes and production facilities of the pharmaceutical industry-Chinese patent medicine production and sewage units

Main production unit main process production facility parameter unit Processing Unit Dry-processed automatic temperature-controlling medicine-driving machine, drum-type medicine-driving machine, medicine-fired unit, calcining machine, other power Wet-fired cooking pot, peony, roaster, other power kW Other other other other Refining unit Dosing machine, other power kW Water extraction tank, other effective volume m3 Alcohol precipitation tank, other effective volume m3 Alcohol extraction tank, other effective volume m3 Concentration tank, other power kW dry Drying heater, drying condenser, spray drying tower, chamber dryer, fluidized bed dryer, spray dryer, red External dryer, microwave dryer, others Power kW Ethanol recovery preheater, plate heat exchanger, high-efficiency alcohol recovery concentrator, alcohol recovery tower, ethanol storage tank, other power kW Medicine residue discharge residue, medicine residue discharge space, other area m2 Other other other other Preparation unit solid preparations Granulator, pelletizer, drying heater, drying condenser, spray drying tower, chamber dryer, fluidized bed dryer, Spray dryer, infrared dryer, microwave dryer, others Power kW Semi-solid preparation heating tank, hot air circulation incubator, hot-press coating machine, other power kW Liquid preparation bottle washing machine, filling machine, other power kW Gas preparation filling machine, other power kW Common unit Wastewater treatment integrated wastewater treatment station, domestic sewage treatment station, other processing capacity m3/d Storage area of solid waste, other area m2 Pure water preparation demineralized water equipment, deionized water equipment, other processing capacity m3/d

4.3.3 Production facility number

The pollutant discharge unit shall report the internal production facility number, or number and report according to HJ 608.

4.3.4 Product name

The product name should be filled in according to the drug name approved by the State Drug Administration. If different products are produced by the same production unit, Fill in all product names.

4.3.5 Product Specifications and Product Quantity

The unit of product specification is mg/tablet, mg/grain, mg/pill, mg/pack, mg/bottle, ml/branch, ml/bottle, ml/bag, others.

Product quantity refers to the annual production quantity corresponding to the product specifications. The unit of the product quantity is 100 million tablets/a, 100 million tablets/a, 100 million pills/a, 100 million packets/a, 100 million pieces/a, 100 million bottles/a, and others.

4.3.6 Production capacity and measurement unit

The production capacity is the design capacity of the main products, excluding the capacity eliminated or banned by the national or local government. Production capacity measurement unit is t/a.

The production capacity of solid preparations, semi-solid preparations and gas preparations is calculated according to formula (1).

ii nBS

1.0 (1)

Where. S--production capacity, t/a;

Bi--i product specifications, mg/bottle, mg/capsule, mg/tablet, mg/pack, mg/pill;

ni--the quantity of the i product, 100 million bottles/a, 100 million tablets/a, 100 million tablets/a, 100 million packets/a, 100 million pills/a m--the number of product specifications.

The production capacity of liquid preparations is calculated according to formula (2).

ii nBS xxx=

100 (2)

Where. S--production capacity, t/a;

Bi--i product specifications, ml/piece, ml/bottle, ml/bag;

ni--the quantity of the i-th product, 100 million pieces/a, 100 million bottles/a, 100 million bags/a;

rhoi--the density of product i, g/ml;

m--the number of product specifications.

4.3.7 Design annual production time

Fill in according to the annual production time in the environmental impact assessment document and approval opinions or the local government's identification or filing document of the illegal project.

If there is no relevant document or the production time is not specified in the document, fill in the actual production time.

4.3.8 Other

If the pollutant discharge unit needs to explain, it can be filled in.

4.4 Main raw materials and fuels

4.4.1 General principles

The main raw and auxiliary materials and fuels should be filled in with the types of raw and auxiliary materials and fuels, the designed annual consumption and the unit of measurement;

Composition and proportion; fuel composition, including ash, sulfur, volatile matter, calorific value; others.

4.4.2 Raw and auxiliary materials and fuel types

The raw materials include the processing of traditional Chinese medicine decoction pieces and the basic raw materials for the production of proprietary Chinese medicines. Specific substance names should be filled in, see Appendix A.

Excipients refer to chemicals or other substances added in the process and wastewater and waste gas treatment processes, including catalysts, solvents, additives, etc.

See Appendix A.

Fuel types include. coal, diesel, natural gas, biogas, liquefied petroleum gas, and others.

4.4.3 Design annual consumption and measurement unit

The designed annual consumption is the annual consumption of raw and auxiliary materials and fuels that match the production capacity. The unit of measurement for design annual usage is t/a or Nm³/a.

4.4.4 Toxic and harmful components and proportion of raw and auxiliary materials

In order to give priority to the inventory of chemicals and the proportion of toxic and hazardous substances or elements specified in relevant documents, Fill in the actual production value, and the original and auxiliary materials do not contain toxic and hazardous substances or elements.

4.4.5 Other

If the pollutant discharge unit needs to explain, it can be filled in.

4.5 Production and discharge links, pollutants and pollution treatment facilities

4.5.1 General principles

Waste gas production and discharge links, pollutants and pollution treatment facilities include the production and discharge links, pollutant items, and emission forms corresponding to production facilities (Organized, unorganized), pollution treatment facilities, whether it is a feasible technology, the number and name of the organized discharge outlets, and whether the discharge outlet settings are consistent Meet the requirements and type of discharge port.

Wastewater categories, pollutants, and pollution treatment facilities include wastewater categories, pollutant projects, pollution treatment facilities, discharge destinations, and discharge parties Type, discharge rule, discharge port number and name, whether the discharge port setting meets the requirements and the type of discharge port.

4.5.2 Exhaust gas

4.5.2.1 Production and discharge links, pollutant projects, emission forms and pollution treatment facilities refer to Table 2 for the waste gas production and discharge links of pollutant discharge units, pollutant items, emission forms and pollution treatment facilities. Sewage unit Dye items are determined according to GB 14554 and GB 37823. Where there are local requirements for emission standards, they shall be determined strictly in accordance with local emission standards.

Table 2 Pharmaceutical industry-Chinese patent medicine production and discharge units

Main production unit main Craft Production facilities Exhaust emissions Dirty link Pollutant project Emission Pollution control facilities exhaustion hole Types of Whether the pollution treatment process is a feasible technology Processing Unit Dry method Burn Automatic temperature-controlling medicine-driving machine, drum-type medicine Machine, roasting machine, calcining machine Dry fire Exhaust gas Particles organized /Unorganized Bag dust removal, electrostatic dust removal, wet dust removal, others Yes -no -If it does not belong to "6 Pollution prevention technology Technical requirements " Relevant evidence should be provided Ming materials General vent Absorption of odor concentration, adsorption of activated carbon, others Refining unit Dosing machine dosing exhaust particulate matter Organized /Unorganized Bag dust removal, electrostatic dust removal, wet dust removal, others General vent Alcohol precipitation tank alcohol precipitation exhaust gas NMHCa, TVOCa Organized /Unorganized Absorption, catalytic oxidation, others Alcohol extraction tank, alcohol extraction waste gas, NMHCa, TVOCa Organized /Unorganized Condensation, absorption, catalytic oxidation, others Concentrated concentration tank concentrated exhaust gas NMHCa, TVOCa Organized /Unorganized Condensation, absorption, catalytic oxidation, others dry Dry heater, dry condenser, Spray drying tower, chamber dryer, fluidization Bed dryer, spray dryer, red External dryer, microwave dryer Dry exhaust particulates Organized /Unorganized Bag dust removal, electrostatic dust removal, wet dust removal, others NMHCa, TVOCa Organized /Unorganized Absorption, ...