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   发布时间?019-07-25</p> </div> <div id="zhnhrrlr0s" class="pro_detail"> <p><span style="font-size:14px;">1  风险和风险控制的差异</span><br /> <br /> <span style="font-size:14px;">风险和风险控制的差异是两者差异的根源?/span><br /> <br /> <span style="font-size:14px;">电子产品出现残次品影响的是功能,手机坏了不能使用、显示器多了个亮点从老百姓角度出发无外乎退换货,影响不大;</span><br /> <br /> <span style="font-size:14px;">制药车间产品(也就是药?出现残次品将直接影响到人的健康,往往是致病、致残、致死甚至致几代人残疾,影响巨大?/span><br /> <br /> <span style="font-size:14px;">因此,两者对风险的理解和风险的控制有着较大的差异,这也导致了后面诸如水、电、暖、控、文件、验证等系统的差异?/span><br /> <br /> <span style="font-size:14px;">2 暖?(空调 )系统的差?/span><br /> <br /> <span style="font-size:14px;">暖通系统是两者大的相同点,也是净化工程公司拓展业务大的动力?/span><br /> <br /> <span style="font-size:14px;">这里要先提到在暖通系统上有很多相同点,都需要设计一定面积的无尘室,都需要在人流物流动线中设置更衣区域或缓冲区域,都需要在温度、湿度、压力、压差、尘埃粒子等方面进行检测和控制等等?/span><br /> <br /> <span style="font-size:14px;">但两者在暖通系统上也有一些不同,这些不同点主要有?/span><br /> <br /> <span style="font-size:14px;">工业无尘车间的洁净等级要求要高于制药车间,目前微电子行业已经进?0 n m甚至更低的范围,而细菌或细菌碎片要在几百nm以上,因此工业无尘车间一般的洁净等级以百级、千级、万级居?所谓百级,是指?.5m尘埃粒子不多?00个/ft3),要求高的工业无尘车间有十级和一级,一般制药车间以万级、十万级居多,要求高的制药车间有千级和局部百级,(局部百级是指房间是千级或万级,但房间内的某设备内部空间是百级,而非房间百级),制药车间没有十级和一级的无尘室;</span><br /> <img style="max-width:100%;" src="/uploads/image/20190725/20190725182228_9843.jpg" alt="" /><br /> <span style="font-size:14px;">由于静电对电子产品有比较大的影响,因此工业无尘车间的湿度控制要求比较严格,而制药车间对湿度要求比较宽泛,尤其是原料药或者封装成品药对房间湿度控制往往是“名存实亡”,有加湿设备但日常不需要运作,设计中需要弱化以节约成本?/span><br /> <br /> <span style="font-size:14px;">和工业无尘车间相比,制药车间的空调系统需要有消毒灭菌的设备,一般通过在AHU(组合式空调箱)中增加臭氧发生器、甲醛熏蒸设备、气态过氧化?VHP)发生器中的一种或多种来实?GMP要求需要两种或两种以上的灭菌方式以排除细菌的抗药性影??/span><br /> <br /> <span style="font-size:14px;">防静电要求和灭菌要求的差异影响到库板的选型,工业无尘车间的库板需要选择防静电的库板,制药车间没有此方面的要求,另外由于V H P的腐蚀性,制药车间的库板要选择质量过硬?a href="http://www.cqdaou.com/supply/29.html" target="_blank">彩钢?/a>,杂牌子的彩钢板因为被腐蚀会产生不可逆的影响?/span><br /> <br /> <span style="font-size:14px;">制药车间的排气系统也是设计中的重点,从生物安全性考虑,一些关键房间的排气要增加高效过滤网,防止细菌或病毒被排放到大气中,造成科幻片中的灾难后果;工业无尘车间因为可能使用砷、镓、氟等有毒有害气体,其排气往往需要经过洗涤塔处理,而且工业无尘车间排气量要比制药车间大的多,新风补充量也要大得多?/span><br /> <span style="font-size:14px;">重庆洁净?/span><br /> <span style="font-size:14px;">3  厂房结构的差?/span><br /> <br /> <span style="font-size:14px;">工业无尘车间是人员密集型产业,加上产量大,产品价值密度相对比较低(产品价值密度是指单位体积的产品价值,医药产品一般是按克或者毫克计量,产品价值密度要比工业无尘车间大几个数量?,往往工业无尘车间都设计的比较大,经常能见到几万甚至几十万m2的无尘室,制药车间一般为几千m2的无尘室,上万m2无尘室的制药车间凤毛麟角?/span><br /> <br /> <span style="font-size:14px;">结构方面,很多工业无尘车间采用“三明治”结构,三明治结构是指上层为送风层,中层是生产厂房,下层是回风夹道,这种结构适合大空间厂房,制药车间一般采用常规无尘室设计,使用送风管路和回风管路,没有“三明治”结构中的送回风层?/span><br /> <br /> <span style="font-size:14px;">“三明治”结构的中层地面多使用高架地板的设计,可以更好的控制气流方向,另外上下夹层设置DDC (干盘?,多使用FFU+MAU(风机过滤机单?新风机组)等都是工业无尘车间的特色,制药车间一般只是常规的AHU设计即可?/span><br /> <br /> <span style="font-size:14px;">和高大的工业无尘车间房不同,制药车间更侧重控菌和无菌的设计,往往房间比较小以方便控制气流流向,更衣程序复杂,进出采用更衣室的设计,而非风淋室设计,另外制药车间一般不采用闭门器,在库板连接处采用R角的结构,采用“中字吊梁”而非工业无尘车间采用的“酒杯梁”的等,这些差异都源于制药车间的无尘室的控菌、灭菌的要求?/span><br /> <br /> <span style="font-size:14px;">4 水系统的差异</span><br /> <br /> <span style="font-size:14px;">工业无尘车间用到的水一般叫做RO水和超纯水,类似水质在制药车间叫做纯水和注射水;</span><br /> <br /> <span style="font-size:14px;">工业无尘车间的RO水和制药车间的纯水都是用反渗透原理制备,设备相似,水质相似,都属于过渡水,制药车间因为需要热消毒,在RO膜之后要使用不锈钢材质,要求严格的制药车间一般从原水就开始使用不锈钢材质?/span><br /> <br /> <span style="font-size:14px;">单从水质上来讲,工业无尘车间的超纯水要强于制药车间的注射用水,工业无尘车间的超纯水一般为18M超纯?18M= 0.05m/c m),制药车间法规要求的注射水是<0.20m/cm即可?/span><br /> <br /> <span style="font-size:14px;">工业无尘车间的超纯水采用混床方法制备,采??回同程回路供水,不需要考虑死角和消毒灭菌;制药车间的注射用水采用蒸馏法制备,采用一供一回的大回路循环,用水点有防死角的设计和设备选型,往往和纯蒸汽发生器配合使用,需要有纯蒸汽灭菌;</span><br /> <br /> <span style="font-size:14px;">在消防水系统方面,工业无尘车间的喷淋头在无尘室里面和送回风夹层里面,在制药车间的消防方面有一个矛盾的地方,从消防法规要求,喷淋头、排烟口需要设置在无尘室内部,但从GMP的要求,有洁净等级的无尘室内不可以设置喷淋头、排烟口,因为喷淋头有死角,而且无法耐受消毒药剂(臭氧、甲醛或V H P)的腐蚀,国内常规的做法是无尘室内不设置消防喷淋和排?但需要设置消火栓),在上夹层中设置消防喷淋和排烟;</span><br /> <br /> <span style="font-size:14px;">由于工业无尘车间规模大,需要有很多节能方面的设计,如设??12℃和14?20℃两组冷却水回路,制药车间规模比较小一般只采用一组即可;工业无尘车间的纯水机组一般设置板式换热器提高水温以提高纯水制水率,制药车间纯水机组虽然也有换热器,但目的是热消,而非提高纯水制水率?/span><br /> <br /> <span style="font-size:14px;">5  文件系统的差?/span><br /> <br /> <span style="font-size:14px;">工业无尘车间的文件和大多数工厂相似,只需要达到业主需求即可,一般只需要现场验收资料,相比制药车间项目,因为对药品安全质量的严格要求,制药车间需要有完整的文件验证体系,主要包括U R S(用户需求描?、V M P(验证计划)、R A(风险分析)、FDS(功能规范描述)、DQ(设计确认)、IQ(安装确认)、OQ(操作确认)、PQ(运行确认)等文件,当然也包括FAT(工厂验收)、SAT(现场验收)这些通用验收文件,以上文件一般称为GM P验证文件或者说4Q验证文件,在净化工程建设中,制药车间G M P验证文件的编写要耗费相当的人力、物力、财力?/span><br /> <br /> <span style="font-size:14px;">工业无尘车间一般不需要单独设置资料室,但制药车间需要设置专门的文件档案室以存放资料文件,而且要配备非水消防系统?/span><br /> <br /> <span style="font-size:14px;">6  造价和回款的差异</span><br /> <br /> <span style="font-size:14px;">工业无尘车间面积大,洁净等级高,净化工程方面造价(非专业设备造价) 往往达到几亿元甚至十几亿元,相比,制药车间由于面积小,洁净等级低,一般几千万元的造价就算比较大的项目,从单位面积造价来看,工业无尘车间一般要比制药车间高很多?/span><br /> <br /> <span style="font-size:14px;">电子产品更新换代比较快,业主从计划开始就会对工期十分敏感,恨不得立刻建厂、立刻生产、立刻销售,净化工程回款比较迅速,相比之下制药车间逊色很多,业主从计划开始需要经历药品研发,临床测试,申请药证等工作,其中临床和申领药证耗时往往需要若干年,期间进行建设净化工程规划往往是不紧不慢,净化工程款往往是能拖就拖,这个差异也是净化工程建设中不容小觑的一个因素!</span><br /> <br /> <span style="font-size:14px;">7     结论</span><br /> <br /> <span style="font-size:14px;">制制药车间和工业无尘车间虽然在建设净化工程方面有很多共性,但两者还存在一些差异:</span><br /> <br /> <span style="font-size:14px;">1.    风险和风险控制的差异?/span><br /> <br /> <span style="font-size:14px;">     2.    暖?空调)系统中的:洁净等级的差异、静电要求差异、灭菌设计差异、库板质量要求差异、排气系统差异等?/span><br /> <br /> <span style="font-size:14px;">  3. 厂房结构方面的:规模和密度的差异、结构差异、DDC/ FF U/ M AU/A H U设备使用的差异、更衣设计差异、闭门器差异、R角设计差异、吊梁设计差异等?/span><br /> <br /> <span style="font-size:14px;">     4.    水系统中的:纯水超纯水系统差异、消防设计差异、节能设计差异等?/span><br /> <br /> <span style="font-size:14px;">5.    文件系统的差异和资料室设计的差异等;</span><br /> <br /> <span style="font-size:14px;">6.    造价和回款的差异等?/span><br /> <br /> <span style="font-size:14px;">理解并在设计中体现这些差异会使得净化工程公司在业务拓展和净化工程建设中绕开很多弯路,减少不必要的浪费和损失,也可以更好的为服务社会,为公司创造价值?/span><br /> <span style="font-size:14px;"></span></p> <div id="zhnhrrlr0s" class="tag">相关标签?/div> <div id="zhnhrrlr0s" class="tag"><div>上一?<a href="227.html">重庆洁净室中的防静电</a></div> <div>下一?<a href="225.html">重庆车间净化教你如何申请《消毒产品生产企业卫生许可证?/a></div> </div> </div> <div id="zhnhrrlr0s" class="news_related"> <h4>相关资讯</h4> <ul> <li> <a href="/news/230.html" title="无尘净化车间如何去清洁? rel="nofollow">无尘净化车间如何去清洁?/a> <span class="fr">2019-09-26</span> </li> <li> <a href="/news/229.html" title="重庆净化车间分析洁净室技术发展趋? rel="nofollow">重庆净化车间分析洁净室技术发展趋?/a> <span class="fr">2019-08-17</span> </li> <li> <a href="/news/228.html" title="重庆净化室介绍各种空气过滤器分类及特点" rel="nofollow">重庆净化室介绍各种空气过滤器分类及特点</a> <span class="fr">2019-08-08</span> </li> <li> <a href="/news/227.html" title="重庆洁净室中的防静电" rel="nofollow">重庆洁净室中的防静电</a> <span class="fr">2019-07-25</span> </li> <li> <a href="/news/226.html" title="重庆洁净室分析制药车间和工业无尘车间的差? 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