关于山西嘉源药业有限公司高端生物蛋白药物产业化智能制造应用项目、国药集团威奇达药业有限公司头孢事业部头孢产品高端化升级项目环境影响评价文件拟进行审查公示

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山西嘉源药业有限公司高端生物蛋白药物产业化智能制造应用项目

大同经开区生物科技创新产业园

山西嘉源药业有限公司

山西清韵环保科技有限公司

本工程总投资20500万元。其中环保投资2050万元。建设内容及规模：对原有库房进行改造装修，建设为高端注射剂车间，新增生产设备122台、建设4条生产线，一期工程建设微球生产线及安瓿瓶水针线，生产规模为年产醋酸亮丙瑞林500万支、年产醋酸亮丙瑞林专用溶媒5000万支。二期工程建设卡式瓶针剂生产线及预灌封水针剂线，生产规模为年产司美格鲁肽注射液各500万支。

1、大气环境污染防治措施

一期工程微球生产线产生的有机废气经回收+二级活性炭装置吸附处理，处理后废气由20m高排气筒排放；微球生产线粉磨分装工序产生的颗粒物采取“负压集气+中效过滤器”进行处理。运营期废气中有组织排放的污染物NMHC及TVOC执行《制药工业大气污染物排放标准》（GB37823-2019）表2大气污染物特别排放限值的有关要求；无组织排放的污染物颗粒物执行《大气污染物综合排放标准》（GB16297-1996）表2新污染源大气污染物排放限值中无组织排放监控浓度限值的有关要求；厂区内VOCs无组织排放执行《制药工业大气污染物排放标准》（GB37823-2019）中附录C厂区内VOCs无组织排放限值的有关要求；企业边界无组织排放的污染物非甲烷总烃参照执行《山西省重点行业挥发性有机物（VOCs）2017年专项治理方案》中的有关要求 。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       

2、废水污染防治措施

清洗废水经厂区内现有污水处理站（采用“预处理+气浮+一级水解酸化+UASB厌氧塔+厌氧池+一级好氧+一级沉淀+二级水解酸化+二级好氧+二级沉淀+加药反应+MBR水解酸化池+MBR接触氧化池”处理工艺）处理后排入园区污水管网，最终进入大同市御东污水处理厂。废水排放执行与大同市御东污水处理厂签订的污水处理协议要求及《污水排入城镇下水道水质标准》（GB/T31962-2015）表1中污水排入城镇下水道水质控制项目B级限值。

3、噪声污染防治措施

合理布局，选用低噪设备，生产装置中含有泵类等产噪设备，要采用柔性接头和基础减振等措施，建立设备定期维护，保养的管理制度，以防止设备故障形成的非正常生产噪声；在厂界四周种植绿化带，降低噪声传播。厂界噪声执行《工业企业厂界环境噪声排放 标准》（GB12348-2008）3 类标准。

4、固体废物污染防治措施

废包装材料主要包括废西林瓶、安剖瓶、铝盖、胶塞等收集后外售相关物资回收部门进行综合利用；危险废物废活性炭、废药品、过滤器采用专用的容器收集后在厂区内现有的一座建筑面积为40m²的危险废物贮存点进行贮存，最后由广灵金隅水泥有限公司进行处置。危险废物收集、贮存及运输等过程执行《危险废物贮存污染控制标准》（GB18597-2023）中的有关规定；危险废物收集、贮存、运输过程执行《危险废物收集 贮存 运输技术规范》（HJ2025-2012）等相关要求；一般工业固体废物处置执行《一般工业固体废物贮存和填埋污染控制标准》（GB18599-2020）中的有关规定。

国药集团威奇达药业有限公司头孢事业部头孢产品高端化升级项目

大同经开区医药产业园

国药集团威奇达药业有限公司

大同市蓝创环保科技有限公司

本工程总投资5866.35万元。其中环保投资11万元。建设内容及规模：新增分装机、轧盖机、直线式外壁清洗机、直线式全自动灯检机、高速贴标机各2台、1台全自动装盒机等设备设施，对头孢产品生产线进行高端化升级。改造完成后，头孢制剂产品由1.2亿支/年提升至2亿支/年，其中Ⅰ线、Ⅱ线产能各由原有的6000万支/年提升至1亿支/年。

1、大气环境污染防治措施

分装在封闭车间内全自动分装机进行，新增一套吸尘器用于收集分装过程产生的颗粒物。无组织颗粒物排放执行《大气污染物综合排放标准》（GB16297-1996）表2限值。                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   

2、废水污染防治措施

废水包括注射剂瓶清洗废水、胶塞清洗废水、铝盖清洗废水、生产设备清洗废水、车间工人及办公人员生活污水、纯水制备排水、注射水制备排水、空调循环水系统排水及洗衣废水等，废水与公司其他车间低浓废水混合后进入公司污水站处理站，处理后废水排放大同市御东污水处理厂。废水排放执行与大同市御东污水处理有限责任公司签订的协议要求及《污水排入城镇下水道水质标准》（GB/T31962-2015）B级要求。

3、噪声污染防治措施

合理布局，选用低噪设备，采取基础减振、隔声等措施，降低噪声传播。厂界噪声执行《工业企业厂界环境噪声排放标准》（GB12348-2008）2类区限值要求。

4、固体废物污染防治措施

不合格原材料收集后返回生产厂家；包装桶收集后送废品收购站回收处置；除尘灰、原料药包装袋和不合格半成品暂存于危废贮存库内，定期交由有资质单位处置；生活垃圾集中收集后交由当地环卫部门统一处理。一般工业固体废物执行《一般工业固体废物贮存和填埋污染控制标准》（GB 18599-2020）；危险废物执行《危险废物贮存污染控制标准》（GB18597-2023）要求。