North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. Safety Facilities Completion Acceptance Evaluation Report
Time：2019-03-27
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1. Name of safety assessment project:
North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. North China Pharmaceutical Penicillin Sodium Salt (Potassium Salt) Technology Upgrade and Relocation Project Safety Facilities Completion Acceptance Evaluation Report
2. Introduction to the safety assessment project:
North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. North China Pharmaceutical North China Pharmaceutical Penicillin Sodium Salt (Potassium Salt) Technology Upgrading and Removal Project uses the sodium carbonate method independently developed by the 103 workshop of North China Pharmaceutical Factory to produce penicillin sodium salt. The BA (butyl penicillinate ester extract) is prepared by industrial hydrochlorination of penicillin potassium, and then extracted by decolorization and sodium carbonate solution to obtain penicillin sodium saline solution (RB), and then the penicillin G sodium salt is obtained by azeotropic crystallization of butanol. The production scale of penicillin sodium salt is 700 tons/year, and the production scale of penicillin potassium salt is 100 tons/year. This project mainly includes the production workshop of penicillin injection sodium salt (potassium salt), fire tank and pump room, waste room and related auxiliary facilities.
The raw and auxiliary materials of this project include green G potassium industrial powder, primary BA, sulfuric acid, n-butanol, n-butyl acetate, ethyl acetate, sodium carbonate, potassium carbonate, activated carbon, acetic acid, ethanol, liquid nitrogen (nitrogen), dichloromethane, and the products are penicillin sodium salt and penicillin potassium salt. The products of this project do not belong to hazardous chemicals. The raw and auxiliary materials used involve hazardous chemicals (sulfuric acid, butanol, butyl acetate, ethyl acetate, acetic acid, ethanol, liquid nitrogen (nitrogen), dichloromethane). Among them, ethyl acetate belongs to the hazardous chemicals under key supervision. This project does not involve the hazardous chemical processes under key supervision and does not constitute a major hazard source of hazardous chemicals.
The project was initiated in June 2015, safety conditions were evaluated in December 2015, and safety conditions were reviewed by the Shijiazhuang Gaocheng District Safety Supervision Bureau. In February 2016, safety facilities were designed and safety facilities were reviewed by the Shijiazhuang Gaocheng District Safety Supervision Bureau. The project entered the construction stage in March 2016 and was completed in June 2018. On July 1, 2018, the project began trial production, and the product output and quality met the design requirements.
In August 2018, North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. commissioned our company to conduct a safety acceptance evaluation of the project.
3. Safety evaluation project leader, technical leader, process control leader, evaluation report compiler, report auditor, safety evaluator, registered safety engineer, and technical expert involved in the evaluation:
Safety evaluation project leader: Zhou Junhong
Technical person in charge: Cao Shuhua
Person in charge of process control: Wang Lin
Evaluation Report Compilers: Zhou Junhong, Sun Guang, Yang Jiangming, Ma Junxing
Report Reviewer: Gao Weili
Safety evaluators, registered safety engineers, and technical experts participating in the evaluation work: Zhou Junhong, Sun Guang, Yang Jiangming, Ma Junxing
4. List of personnel, time, and main tasks to carry out safety evaluation work on site, and evaluation report time:
North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. officially commissioned North Huafei Technology Consulting Co., Ltd. to conduct safety acceptance evaluation work on its penicillin sodium salt (potassium salt) technology upgrade and relocation project, and signed a safety acceptance evaluation service contract. Hebei Huafei Technology Consulting Co., Ltd. established an evaluation team in a timely manner, carefully collected relevant evaluation materials, and went to the site again to inspect the project site selection, general layout, project construction content, specific process, etc., and made a good record. During the evaluation process, the members of the evaluation team carefully analyzed and sorted out the relevant materials provided by the enterprise and collected on site. After solid work, the completion and acceptance evaluation report of the safety facilities of this project was compiled in October 2018.