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Draft for Environmental Impact Assessment of the Upgrading and Reconstruction Project of Featured API Production Center of CSPC Ouyi Pharmaceutical Co., Ltd. Publicized

Posted on: October 17, 2019 Posted by: CSPC


The “Environmental Impact Report of the Upgrade Project of Special Pharmaceutical Ingredients Production Center of CSPC Ouyi Pharmaceutical Co., Ltd.” (draft for comments) has been completed. According to the “Environmental Impact Assessment Public Participation Measures”, the project has been widely consulted with the project environment. Opinions related to the impact, the environmental impact related information of this project is now publicized as follows:

I. Overview of the environmental impact report (draft for comments)

1. Project Overview

Project Name: Upgrading and Reconstruction Project of Specialty API

Construction unit: CSPC Ouyi Pharmaceutical Co., Ltd.

Project Nature: Expansion

Construction site: The project is located in the factory area of No. 88 Yangzi Road (Shijiazhuang Ouyi Pharmaceutical Co., Ltd.) in Shijiazhuang Economic and Technological Development Zone. The geographical coordinates of the center of the site are 38 ° 01'34.13 "north latitude and 114 ° 42'47.55" east longitude.

2. Project scale and main construction content

CSPC Ouyi Pharmaceutical Co., Ltd. has completed the filling and upgrading of the asimicin production line, alendronate sodium, amlodipine maleate production line, solvent recovery production line, and traditional Chinese medicine production line for specialty drug substance production centers. , 43 new sets of main process equipment (sets) were added. After the project is completed, according to market demand, a flexible production method of co-line products will be used to add indomethacin, nitrendipine, and vitamin production capacity to the asimicin production line. Among them, the maximum annual production capacity of indomethacin is 17 t / a. Nitrendi has a maximum annual production capacity of 90t / a, and vitamin BT has a maximum annual production capacity of 12t / a. On the basis of alendronate sodium and amlodipine maleate production lines, ranitidine hydrochloride, ambroxol hydrochloride, The production capacity of clopidogrel hydrogen sulfate, of which the maximum production capacity of ranitidine hydrochloride is 35t / a, the maximum production capacity of ambroxol hydrochloride is 35t / a, the maximum production capacity of clopidogrel hydrogen sulfate is 12t / a, and the p-toluenesulfonyl chloride recovery capacity is 200t / a.

3. Main environmental impacts and governance measures

(1) Exhaust gas

The air pollution sources of this project include organized exhaust gas and unorganized exhaust gas in the workshop.

Asimimethine plant (mainly producing vitamin BT, nirendipine and indomethacin) and horse ammonia plant (mainly producing ranitidine hydrochloride, ambroxol hydrochloride and clopidogrel hydrogen sulfate) process waste gas treatment measures are the same. The chlorine-free process exhaust gas is treated by "alkali absorption + water absorption + catalytic combustion device", and the treated exhaust gas is discharged through a 30m high exhaust cylinder. The exhaust gas from the workshop is collected by the negative pressure of the air inlet of the workshop, and is discharged into the organized exhaust cylinder after being treated with alkali + water. Exhaust gas from Asimesin workshop and Ma ammonia workshop will be discharged from their respective 30m high exhaust cylinders after being treated by their respective exhaust gas treatment systems.

The p-toluenesulfonyl chloride recovery process in the solvent recovery workshop includes chlorine-containing organic waste gas, azithromycin-containing organic waste gas, asimicin, chlorine-containing organic waste gas, and chlorine-containing organic waste gas in the ammonia plant, using "deep condensation + alkali absorption + water absorption + two -Grade activated carbon adsorption + steam desorption condensation treatment "treatment, chlorine-free organic waste gas, using" alkali absorption + water absorption + catalytic combustion treatment "treatment, low concentration water-soluble organic waste gas treatment using alkali absorption + water absorption After the three exhaust gases are combined, they are emitted from a 30m high exhaust cylinder.

The exhaust gas from the Chinese medicine extraction workshop is treated with a "gas collecting hood + bag filter" and discharged by a 30m high exhaust cylinder; the process exhaust gas from the Chinese medicine extraction workshop is treated with "deep condensation + alkali absorption + water absorption + catalytic combustion". After the workshop exhaust gas is subjected to "water absorption treatment", the exhaust gas is combined and discharged from a 30m high exhaust cylinder; the spray drying exhaust gas of the Chinese medicine extraction workshop is treated with "water curtain dust removal + washing tower + low temperature plasma", and then the 30m exhaust cylinder.

The unorganized exhaust gas in the workshop is discharged after strengthening the organized collection to reduce the running, dripping, dripping and leaking of equipment and pipelines, and strengthening the process operation and equipment management. The storage tank is cooled by condensers, and the non-condensable exhaust gas is introduced into the tank area for exhaust gas absorption. Emissions after treatment of the unit, measures to strengthen operation management.

The concentration of non-methane total hydrocarbon emissions meets the special emission limits in Table 2 of the "Pharmaceutical Industry Air Pollutant Emission Standards" (GB37823-2019) and the "Volatile Organic Compound Emission Control Standards for Industrial Enterprises" (DB13 / 2322-2016) Table 1 The manufacturing industry requires that the emission concentration of particulate matter, hydrogen chloride, and benzene series meet the special emission limits in Table 2 in the "Emission Standards for Air Pollutants of the Pharmaceutical Industry" (GB37823-2019), and the emission concentrations of non-methane total hydrocarbons, methanol, and acetone meet the "industrial enterprises Volatile Organic Compounds Emission Control Standards (DB13 / 2322-2016) Table 1 Chinese medicine manufacturing industry requirements, trimethylamine emissions meet the Table 2 standards of the "Emission Standard for Odor Pollutants" (GB14554-93).

(2) Wastewater

The wastewater generated by this project includes process wastewater, equipment cleaning wastewater, production floor washing wastewater, vacuum pump drainage, and workshop exhaust gas treatment measures. All of the above wastewater enters the wastewater treatment station and passes through the "regulation tank + ABR1 biochemical + SBR1 biochemical + ABR2 biochemical + SBR2 "Biochemical + flocculation sedimentation + aerated biological filter" treatment meets the standard and is discharged into the sewage pipe network of the Shijiazhuang Economic and Technological Development Zone together with the pure sewage water from the purified sewage, and discharged to the sewage treatment plant of the Shijiazhuang Economic and Technological Development Zone for treatment.

In summary, the wastewater treatment measures of this project are feasible.

(3) Noise

The project selected low-noise equipment, basic vibration reduction, plant sound insulation and fan mufflers to control the boundary noise of the plant to meet Class 3 requirements of the "Environmental Noise Emission Standard for Industrial Plants" (GB12348-2008).

(4) Solid waste

The solid wastes of the project are properly disposed without adversely affecting the environment.

4. Conclusion of environmental impact assessment

The project construction meets the requirements of national industrial policies; the pollution control measures are reliable and effective, and pollutants can be discharged in compliance with the standards; the total amount of pollutants discharged meets the requirements for total amount control, and the project has good economic and social benefits. Under the conditions of comprehensively strengthening supervision and management, implementing the "three simultaneous" environmental protection system and earnestly implementing various environmental protection measures, from the perspective of environmental protection analysis, the project construction is feasible.

  • Public scope for comment

Citizens, legal persons and organizations within the scope of the environmental impact assessment of this project shall encourage citizens, legal persons and other organizations outside the scope of the environmental impact assessment to participate.

Ways and means of public comments

During the publicity period, if you have any comments or suggestions, you can download the public opinion form to fill it out, and directly feedback to the construction unit and the environmental assessment unit through the contact methods below.

1. Construction unit: CSPC Ouyi Pharmaceutical Co., Ltd.

Li Shaofang Telephone: 15393095532

2. EIA unit: Hebei Qizheng Environmental Technology Co., Ltd.

Hong Hao Tel: 0311-83033190; Email: 276757260@qq.com

  1. Public comment form web link: (see attachment)

Fourth, the start and end time of public comments

From October 17, 2019 to October 23, 2019.

V. How to Obtain the Draft of Environmental Impact Report

1. Network link for comments: (see attachment)

2. How to obtain the paper report: CSPC Ouyi Pharmaceutical Co., Ltd.

Address: Shijiazhuang Economic and Technological Development Zone