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| 化学药品原料药制造业自行监测技术指南设计研究 |
| Study on Design of Self monitoring Technology Guidelines for Chemical Medicine Active Pharmaceutical Ingredient Manufacturing Industry |
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| DOI： |
| 中文关键词: 化学药品原料药制造业 工艺类型 自行监测 |
| 英文关键词: Chemical medicine active pharmaceutical ingredient manufacturing industry Production type Self monitoring |
| 基金项目:中国环境监测总站“编制排污单位自行监测指南（化学药品原料药制造行业）”基金资助项目（JCZN-2015-06）；南京市环境保护局课题“南京市医药工业企业污染排放现状调查及防治对策”基金资助项目（201608） |
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| 中文摘要: |
| 通过分析化学药品原料药制造业的基本情况、产品种类和生产工艺，以及自行监测技术指南编制的目的和基本要求，梳理出确定监测点位和对应多项污染物排放标准为目前该行业自行监测技术指南编制工作的难点。根据以上分析，提出将指南按工艺类型拆分、监测点位和废气监测指标的确定、监测频次的优化、生产记录内容的设定列为指南编制工作的重点。 |
| 英文摘要: |
| Through the analysis on basic characteristic, product category, production process, and the objective and requirements of self monitoring technology guidelines design for chemical medicine active pharmaceutical ingredient (API) manufacturing industry, monitoring site setting and emission standards of pollutants were sought out as the difficulties in the guidelines design. According to those analysis above, it pointed out the guidelines should be classified by production types. The determination of monitoring site, monitoring factors and frequency, production records were listed as the key points to the guidelines compilation. |
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