HJ 1062-2019Technical specification for application and issuance of pollutant permit Pharmacy industry -- Biological pharmaceutical products manufacturing (English PDF)

4.1 Basic principles

Pharmaceutical industry-Biopharmaceutical product manufacturing and discharge units shall, in accordance with the requirements of this standard, fill in the corresponding information on the sewage permit platform. Sewage permit However, if the platform does not include the local ecological environment authority that requires reporting or the polluting unit thinks it is necessary to fill in the report, it may add content by itself.

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 the report, select "Pharmaceutical Industry-Biopharmaceutical Product Manufacturing-Biopharmaceutical Product" and "Pharmaceutical Industry-Biopharmaceutical Product Manufacturing-Basic for engineering products and vaccine manufacturing "," Pharmaceutical industry-veterinary drug manufacturing-biopharmaceutical products "," Pharmaceutical industry-veterinary drug manufacturing-Genetic engineering products and vaccine manufacturing "), whether it is put into production, the date of production, the longitude and latitude of the center of the production and operation site, and whether the location is in Environmentally sensitive areas (such as key atmospheric control areas, total nitrogen and total phosphorus control areas, etc.), whether they are located in industrial parks, the names of their industrial parks, construction document Environmental Impact Assessment Document Examination and Approval Opinion Document Number (Recording Number), Local Government's Identification or Record Document Number of Violating Projects, Main document number of total pollutants distribution plan, total particulate matter (t/a), total sulfur dioxide (t/a), total nitrogen oxides (T/a), total volatile organic compounds (t/a), total chemical oxygen demand (t/a), total ammonia nitrogen (t/a), Other pollutant total indicators (if any).

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 Names of 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 the production unit, production process and production facility, you can select "Others" in the declaration system for filling in.

Table 1 List of main production units, main processes, and production facilities of pollutant discharge units

main

produce

unit

Main process production facility parameter unit to produce Fate First name produce Line sheet Yuan a Dosing liquid dosing facility, solid dosing facility, others Power, volume, other kW, L, others Engineering bacteria preparation Engineering bacteria preparation room, other area, other m2, other Inoculation tank, other volume, other L, other Culture incubator, biochemical incubator, other volume, other L, other Fermentation Disinfection tank, growth liquid tank, maintenance liquid tank, washing liquid tank, fermentation tank, feeding tank, other Volume, other L, other extract Acidification tank, adsorption tower, liquid storage tank, crystallization tank, conversion tank, filtrate tank, liquid-liquid Centrifuge, static mixer, extraction tank, extraction tank, filtrate transfer pump, metering Tank, tank to be filtered, decolorized intermediate tank, preparation tank, extraction equipment, sterilizing filter, Sleeve type sterilization filter, others Power, volume, other kW, m3, others purification Large-capacity cryogenic centrifuge, decolorization tank, crystallization tank, automatic chromatography system, silica gel Column chromatography system, microfiltration column system, purification system, ultrafiltration system, membrane filter, Micropore filter, others Power, volume, other kW, m3, others Solvent recovery distillation kettle, distillation column, other volume, other L, other Wash bottle Drum-type bottle washing machine, box-type bottle washing machine, chain type multi-functional ultrasonic cleaning machine, its Power, processing energy Force, other kW, bottle/batch, others Inactivate Laminar flow dry heat sterilizer, high pressure steam sterilizer, water bath sterilizer, wet heat Sterilizer, vacuum sterilizer, others Power, volume, other kW, L, others dry Vacuum dryer, three-in-one device, two-in-one device, hot water tank, hot water pump, Drying heater, micro-heat regenerative dryer, drying condenser, spray drying tower, freeze drying Machine, others Power, volume, other kW, L, others Continued main produce unit Main process production facility parameter unit to produce Fate First name produce Line sheet Yuan a Solid products Mobile lifting feeder, ball mill, pulverizer, powder mixer, mixer, bottle washer, Mixer, granulator, tablet press, efficient coating machine, granulator, sealing machine, aluminum Plastic packaging machine, granulation production line, fully automatic bio-pharmaceutical bottle production packaging line, others Power, volume, other kW, L, others Liquid products Mobile lifting feeder, washing tank, vacuum feeder mixer, bottle washer, mixing Machine, filling machine, sealing machine, aluminum-plastic packaging machine, automatic biopharmaceutical bottle packaging Line, strapping machine, others Power, volume, other kW, L, others Semi-solid products Mobile lifting feeder, heating tank, vacuum feeder mixer, bottle washer, mixing Machine, filling machine, glue cutting machine, sealing machine, packaging machine, strapping machine, other Power, volume, other kW, L, others Other other other other public unit R & D center fume hood, reaction tank, others Air volume,, other m3/h, L, its Material storage Atmospheric pressure tank, fixed roof tank, floating roof tank, cone roof tank, vault roof tank, raw material warehouse, Treasury, others Volume, area, other m3, m2, which Wastewater treatment comprehensive wastewater treatment station, domestic sewage treatment station, other treatment capacity, other m3/d, other Solid waste Store and dispose Hazardous waste temporary storage room, sludge temporary storage room, other area, other m2, other Pure water preparation demineralized water equipment, deionized water equipment, other processing capacity, other m3/d, other Quality inspection center quality inspection equipment, fume hood, other air volume, other m3/h, other Clean room clean area purification facilities, other areas m2, other Animal breeding animal room, other area, other m2, other Other other other other a The production line unit named after the product is used to report the human insulin production line, digestive enzyme production line, rabies vaccine production line, and others.

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.

4.3.5 Product Specifications and Product Quantity

The unit of product specification is mg/bottle, mg/grain, ml/branch, ml/bottle, ml/bag, mg/tablet, mg/bag, mg/pillar, µg/branch, and others.

Product quantity refers to the annual production quantity corresponding to the product specifications. The unit of product quantity is 100 million bottles/a, 100 million tablets/a, 100 million pieces/a, 100 million bags/a 100 million tablets/a, 100 million packets/a, 100 million pills/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 and semi-solid 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 environmental impact assessment documents and approval opinions or the local government's mid-year production time for the identification or filing of illegal items. If There are no relevant documents 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 original and auxiliary materials should be filled with specific substance names. Including. enzymes, microorganisms, solvents, auxiliaries, and others.

Fuel types include. gasoline, diesel, coal, biomass, 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 content of the waste gas production and discharge links of pollutant discharge units, pollutant items, emission forms, pollution treatment facilities and types of discharge outlets.

Pollutant discharge units are determined according to GB 14554 and GB 37823. If there are local requireme...