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class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="udfroa7" class="box"><p><p style="text-indent:25px">潔凈醫(yī)藥潔凈室的布置應(yīng)符合下列規(guī)定:1.在滿足生產(chǎn)工藝和噪聲要求的前提下,空氣潔凈度級(jí)別高的醫(yī)藥潔凈室宜靠近空調(diào)機(jī)房布置,空氣潔凈度級(jí)別相同的工序和醫(yī)藥潔凈室的布置宜相對(duì)集中。2.不同空氣潔凈度級(jí)別醫(yī)藥潔浄室之間的人員出入和物料傳送應(yīng)有防止污染的措施。3.醫(yī)藥工業(yè)潔浄廠房內(nèi),宜靠近生產(chǎn)區(qū)設(shè)置與生產(chǎn)規(guī)模相適應(yīng)的原輔料、半成品和成品存放區(qū)域。存放區(qū)域內(nèi)宜設(shè)置待驗(yàn)區(qū)和合格品區(qū)，上海千級(jí)潔凈室工程,也可采取控制物料待檢和合格狀態(tài)的措施。不合格品應(yīng)設(shè)置專區(qū)存放。4.高致敏***品(青霉素類)、生物制品(如卡介苗類和結(jié)核菌素類)、血液制品的生產(chǎn)廠房應(yīng)**設(shè)置,其生產(chǎn)設(shè)施和設(shè)備應(yīng)**。5.生產(chǎn)β-內(nèi)酰胺結(jié)構(gòu)類藥品、性 ***類避孕藥品、含不同核素的放射***品生產(chǎn)區(qū)必須與其他藥品生產(chǎn)區(qū)嚴(yán)格分開。6，上海千級(jí)潔凈室工程，上海千級(jí)潔凈室工程.炭疽杄菌、肉毒梭狀芽孢杄菌、破傷風(fēng)梭狀芽孢杄菌應(yīng)使用**生產(chǎn)設(shè)施生產(chǎn)。7.某些 ***類、細(xì)胞毒性類、高活性化學(xué)藥品生產(chǎn)區(qū)應(yīng)使用**生產(chǎn)設(shè)施。特殊情況下,當(dāng)采取特別防護(hù)揹施并經(jīng)過必要的驗(yàn)證,上述藥品制劑則可通過階段性生產(chǎn)方式共用同一生產(chǎn)設(shè)施。潔凈室無菌生產(chǎn)潔凈室內(nèi)不應(yīng)設(shè)置地漏和水斗。上海千級(jí)潔凈室工程</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海千級(jí)潔凈室工程,潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265753475012/825781.png"></div><p style="text-indent:25px">潔凈生產(chǎn)區(qū)域的環(huán)境參數(shù)：一般規(guī)定1.藥品生產(chǎn)區(qū)域的環(huán)境參數(shù)應(yīng)符合現(xiàn)行《藥品生產(chǎn)質(zhì)量管理規(guī)范》的規(guī)定。2.醫(yī)藥潔凈室應(yīng)以微粒和微生物為主要控制對(duì)象,同時(shí)尚應(yīng)規(guī)定環(huán)境的溫度、濕度、壓差、照度、噪聲等參數(shù)。3.環(huán)境空氣中不應(yīng)有異味以及影響藥品質(zhì)量和人體健康的物質(zhì)。3藥品生產(chǎn)有關(guān)工序和環(huán)境區(qū)域的空氣潔凈度級(jí)別,應(yīng)符合現(xiàn)行《藥品生產(chǎn)質(zhì)量管理規(guī)范》和本標(biāo)準(zhǔn)附錄A的規(guī)定。確認(rèn) 證明廠房、設(shè)施、設(shè)備能正確運(yùn)行并達(dá)到預(yù)期結(jié)果的一系列活動(dòng)?；S潔凈室改造價(jià)格潔凈室布置應(yīng)根據(jù)凈化空氣調(diào)節(jié)系統(tǒng)的要求綜合協(xié)調(diào)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海千級(jí)潔凈室工程,潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265424246549/8062950.png"></div><p style="text-indent:25px">潔凈要求：在醫(yī)藥潔凈室隔墻上設(shè)置的傳遞物料和工器具的窗口,兩側(cè)裝有不能同時(shí)開啟的窗扇。1.潔凈工作服醫(yī)藥潔凈室內(nèi)使用的**工作服。2.空態(tài) 設(shè)施已經(jīng)建成,所有動(dòng)力接通并運(yùn)行,但無生產(chǎn)設(shè)備、物料及人員。3.靜態(tài)所有生產(chǎn)設(shè)備已經(jīng)安裝就位,但沒有生產(chǎn)活動(dòng)且無操作人員在現(xiàn)場的狀態(tài)。4.動(dòng)態(tài)設(shè)施以規(guī)定的狀態(tài)運(yùn)行,有規(guī)定的人員在場,并在商定的狀態(tài)下工作5.高效空氣過濾器在額定風(fēng)量下,按zui 易穿透粒徑(MPPS)粒子的捕集效率在99.95%以上的空氣過濾器。6.醫(yī)藥工藝用水醫(yī)藥生產(chǎn)工藝過程中使用的水,包括生活飲用水、純化水、注射用水。</p><p style="text-indent:25px">潔凈醫(yī)藥潔凈室的照明應(yīng)根據(jù)生產(chǎn)要求設(shè)置,并應(yīng)符合下列規(guī)定:1、主要工作室一般照明的照度值宜為300lx2、輔助工作室、走廊、氣鎖、人員凈化和物料凈化用室的照度值宜為200lx;3、對(duì)照度有特殊要求的生產(chǎn)崗位可根據(jù)需要局部調(diào)整4、不同空氣潔凈度級(jí)別的醫(yī)藥潔凈室之間以及潔凈室與非潔凈室之間的空氣靜壓差不應(yīng)小于10Pa,醫(yī)藥潔凈室與室外大氣的靜壓差不應(yīng)小于10Pa。非單向流醫(yī)藥潔凈室的噪聲級(jí)(空態(tài))不應(yīng)大于60dB(A),單向流和混合流醫(yī)藥潔凈室的噪聲級(jí)(空態(tài))不應(yīng)大于65dB(A)。潔凈室潔凈室內(nèi)設(shè)備通氣口應(yīng)設(shè)置除菌過濾器。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="上海千級(jí)潔凈室工程,潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265560613581/2907407.png"></div><p style="text-indent:25px">醫(yī)藥工業(yè)潔凈廠房設(shè)計(jì)標(biāo)準(zhǔn)：1 總則1.為在醫(yī)藥工業(yè)潔浄廠房設(shè)計(jì)中貫徹執(zhí)行國家有關(guān)方針政策,做到技術(shù)先進(jìn)、安全可靠、確保質(zhì)量、節(jié)能環(huán)保,制定本標(biāo)準(zhǔn)。2.本標(biāo)準(zhǔn)適用于新建、擴(kuò)建和改建的醫(yī)藥工業(yè)潔凈廠房設(shè)計(jì)。生物制品、毒***品、**、**品以及放射***品的生產(chǎn)和質(zhì)量檢驗(yàn)設(shè)施除應(yīng)執(zhí)行本標(biāo)準(zhǔn)外,尚應(yīng)符合國家有關(guān)的監(jiān)管規(guī)定。3.醫(yī)藥工業(yè)潔凈廠房的設(shè)計(jì)應(yīng)為施工安裝、系統(tǒng)設(shè)施驗(yàn)證、維護(hù)管理、檢修測試和安全運(yùn)行創(chuàng)造必要的條件。4.醫(yī)藥工業(yè)潔凈廠房的設(shè)計(jì)除應(yīng)符合本標(biāo)準(zhǔn)外,尚應(yīng)符合國家現(xiàn)行有關(guān)標(biāo)準(zhǔn)規(guī)范的規(guī)定。潔凈室應(yīng)設(shè)置在大氣含塵、含菌濃度低、自然環(huán)境較好的區(qū)域。浙江千級(jí)潔凈室</p><p style="text-indent:25px">潔凈室室內(nèi)的管道絕熱保護(hù)層表面應(yīng)平整光滑,無顆粒性物質(zhì)脫落。上海千級(jí)潔凈室工程</p><p style="text-indent:25px">潔凈廠總平面布置：1.廠區(qū)的總平面布置應(yīng)符合國家有關(guān)工業(yè)企業(yè)總平面設(shè)計(jì)要求、滿足環(huán)境保護(hù)的要求,同時(shí)應(yīng)避免交叉污染。2.廠區(qū)應(yīng)按生產(chǎn)、行政、生活、輔助等不同使用功能合理分區(qū)布局。3.醫(yī)藥工業(yè)潔浄廠房應(yīng)布置在廠區(qū)內(nèi)環(huán)境清潔,且人流、物流不穿越或少穿越的地段,并應(yīng)根據(jù)藥品生產(chǎn)特點(diǎn)布局。4.兼有原料藥和制劑生產(chǎn)的藥廠,原料藥生產(chǎn)區(qū)應(yīng)位于制劑生產(chǎn)區(qū)全年zui 小頻率風(fēng)向的上風(fēng)側(cè)。三廢處理、鍋爐房等有較嚴(yán)重污染的區(qū)域,應(yīng)位于廠區(qū)全年zui 小頻率風(fēng)向的上風(fēng)側(cè)。5.青霉素類等高致敏***品的生產(chǎn)廠房,應(yīng)位于其他醫(yī)藥生產(chǎn)廠房全年zui 小頻率風(fēng)向的上風(fēng)側(cè)。上海千級(jí)潔凈室工程</p></p><br /><p>文章來源地址: http://m.cdcfah.com/cp/3061589.html</p></div></div></div></div></div><div id="ra3fyja" class="page-right twoColRt"><div id="2oqczli" class="box01 margin10 clearfix"><h3><a href="http://m.cdcfah.com/cp/">猜你喜歡</a></h3><div id="hwolse8" class="recomPic likePro"><a href="http://m.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" 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