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href="http://www.cdcfah.com/cp/third-cjsb_wccj/">無塵車間</a>?純凈水生產(chǎn)潔凈室改造上海譽茂凈化科技供應</p><div id="z8qxzgf" class="leftbox clearfix"><h1>純凈水生產(chǎn)潔凈室改造上海譽茂凈化科技供應</h1><div id="3lnfcei" class="proBig"><div id="vebdvr4" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/shyumao/637387265488582337/3253507.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="rjwtv3a" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/shyumao/637387265488582337/3253507.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="s0frdkj" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>純凈水生產(chǎn)潔凈室改造,潔凈室</p><p><span>***更新：</span>2021-01-21 07:13:52</p><p><span id="click" >瀏覽次數(shù)：1次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="xl333pk" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">上海譽茂凈化科技有限公司</a></p><p><span>聯(lián)系人：</span>婁經(jīng)理</p><p><span>郵箱: </span>in@clenym.com</p><p><span>電話: </span>17269664943</p><p><span>傳真: </span>021_</p><p><span>網(wǎng)址: </span>https://www.cleanym.com</p><p><span>手機: </span>021-00000000</p><p><span>地址: </span>長壽路868號中港匯大廈</p><p>[當前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="wfxug77" class="page-proshow02"><p class="title">詳細說明</p><div id="mfm2zqu" class="box"><p><p style="text-indent:25px">潔凈無菌生產(chǎn)潔凈室內(nèi)不應設(shè)置地漏和水斗。無菌生產(chǎn)潔凈室所用的水應經(jīng)過滅菌處理。無菌生產(chǎn)潔凈室內(nèi)的設(shè)備/器具使用完畢后應移出本區(qū)域清洗,并經(jīng)過滅菌后進入。采用在線清洗在線消毒的生產(chǎn)設(shè)備,其下水/凝水應直接排出無菌生產(chǎn)潔凈室外。1.無菌生產(chǎn)潔凈室內(nèi)設(shè)備通氣口應設(shè)置除菌過濾器。滅菌產(chǎn)生的水蒸氣應排出無菌生產(chǎn)潔凈室。2.無菌生產(chǎn)潔凈室應設(shè)置環(huán)境消毒/滅菌設(shè)施.以降低環(huán)境的微生物負荷。無菌生產(chǎn)潔凈室內(nèi)使用的清洗劑/消毒劑應經(jīng)過滅菌/除菌處理。3，純凈水生產(chǎn)潔凈室改造.無菌生產(chǎn)潔凈室的凈化更衣設(shè)施應滿足本標準第5.2.2條、第5，純凈水生產(chǎn)潔凈室改造.2，純凈水生產(chǎn)潔凈室改造.4條的要求。潔凈室無菌藥品法定藥品標準中列有無菌檢査項目的制劑和原料藥。純凈水生產(chǎn)潔凈室改造</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="純凈水生產(chǎn)潔凈室改造,潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265488582337/3253507.png"></div><p style="text-indent:25px">潔凈特點：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。1.純化水蒸餾法、離子交換法、反滲透或其他適宜的方法制得的,不含任何附加劑,供藥用的水,其質(zhì)量符合現(xiàn)行《中華人民共和國藥典》純化水項下的規(guī)定2注射用水純化水經(jīng)蒸餾制得的水,其質(zhì)量符合現(xiàn)行《中華人民共和國藥典》注射用水項下的規(guī)定。3.自凈時間醫(yī)藥潔凈室被污染后,凈化空氣調(diào)節(jié)系統(tǒng)在規(guī)定的換氣次數(shù)條件下開始運行,直至恢復到固有的靜態(tài)標準時所需時間。4.恢復時間醫(yī)藥潔浄室生產(chǎn)操作全部結(jié)束、操作人員撤出現(xiàn)場,空氣中的懸浮粒子達到靜態(tài)標準時所需時間。5.無菌沒有***微生物存在。5.無菌藥品法定藥品標準中列有無菌檢査項目的制劑和原料藥。6.非無菌藥品法定藥品標準中未列有無菌檢査項目的制劑和原料藥。上海光學潔凈室潔凈室常溫保存的環(huán)境,其溫度范圍應為10℃~30℃。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="純凈水生產(chǎn)潔凈室改造,潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265588953471/8136390.png"></div><p style="text-indent:25px">潔凈物料凈化：1.醫(yī)藥潔凈室的原輔料、包裝材料和其他物品出入口,應設(shè)置物料凈化用室和設(shè)施。2.進入無菌生產(chǎn)潔浄室的原輔料、包裝材料和其他物品,除應符合本標準第5.3.1條的規(guī)定外,尚應在岀入口設(shè)置供物料、物品滅菌用的滅菌室和滅菌設(shè)施。3.物料清潔室或滅菌室與醫(yī)藥潔凈室之間應設(shè)置氣鎖或傳遞柜。氣鎖的靜態(tài)凈化級別應與其相鄰高級別醫(yī)藥潔凈室一致。4.傳遞柜應密閉良好,并應易于清潔。兩邊的傳遞門應有防止同時被開啟的措施。傳遞柜的尺寸和結(jié)構(gòu)應滿足傳遞物品的要求。傳送至無菌生產(chǎn)潔凈室的傳遞柜應有相應的凈化設(shè)施。5.醫(yī)藥潔凈室產(chǎn)生的廢棄物應有傳出通道。易產(chǎn)生污染的廢棄物應設(shè)置單獨的出口。具有活性或毒性的生物廢棄物應滅活后傳出。</p><p style="text-indent:25px">醫(yī)藥潔凈室環(huán)境微生物監(jiān)測的動態(tài)標準:1.藥品生產(chǎn)有關(guān)工序和環(huán)境區(qū)域的空氣潔凈度級別,應符合現(xiàn)行《藥品生產(chǎn)質(zhì)量管理規(guī)范》和本標準附錄A的規(guī)定。醫(yī)藥潔凈室的溫度和濕度設(shè)計參數(shù)應符合下列規(guī)定:1、藥品生產(chǎn)工藝及產(chǎn)品對溫度和濕度有特殊要求時,應根據(jù)工藝及產(chǎn)品要求確定;2、藥品生產(chǎn)工藝及產(chǎn)品對溫度和濕度無特殊要求時,空氣潔凈度A級、B級、C級的醫(yī)藥潔凈室溫度應為20℃~24℃,相對濕度應為45%~60%;空氣潔凈度D級的醫(yī)藥潔凈室溫度應為18℃~26℃,相對濕度應為45%~65%。潔凈室當工藝需要必須在醫(yī)藥潔凈室內(nèi)設(shè)置物料垂直輸送的裝置。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="純凈水生產(chǎn)潔凈室改造,潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265279461239/5769154.png"></div><p style="text-indent:25px">潔凈凈化空氣調(diào)節(jié)系統(tǒng)在下列生產(chǎn)場所中的空氣不應循環(huán)使用:1.生產(chǎn)中使用有機溶媒,且因氣體積聚可構(gòu)成或火災危險的工序。2.三類(含三類)危害程度以上病原體操作區(qū)。3.放射***品生產(chǎn)區(qū)。凈化空氣調(diào)節(jié)系統(tǒng)設(shè)計應合理利用回風。但下列生產(chǎn)場所的空氣不應循環(huán)使用:1.生產(chǎn)過程中散發(fā)粉塵的工序,當空氣經(jīng)處理仍不能避免交叉污染時;2.生產(chǎn)過程中產(chǎn)生有害物質(zhì)、異味、大量熱濕或揮發(fā)性氣體的工序。生產(chǎn)過程中散發(fā)粉塵較集中的設(shè)備或區(qū)域應設(shè)置除塵設(shè)施。采用單機除塵時,除塵器應設(shè)置在靠近發(fā)塵點的機房內(nèi);機房門向醫(yī)藥潔浄室方向開啟的.機房內(nèi)環(huán)境要求應與醫(yī)藥潔凈室相同。間歇使用的除塵系統(tǒng),應有防止醫(yī)藥潔凈室壓差變化的措施。凈化含有危險性粉塵的除塵系統(tǒng),應采用有泄爆和防靜電裝置的防爆除塵器。防爆除塵器應設(shè)置在排塵系統(tǒng)的負壓段,并應設(shè)置在**的機房內(nèi)或室外。潔凈室無菌生產(chǎn)潔凈室應**于采用無菌生產(chǎn)工藝的藥品的生產(chǎn),不應用于其他藥品的生產(chǎn)。純凈水生產(chǎn)潔凈室改造</p><p style="text-indent:25px">潔凈室傳入無菌生產(chǎn)潔凈室的物品應有滅菌和消毒設(shè)施。純凈水生產(chǎn)潔凈室改造</p><p style="text-indent:25px">潔凈凈化空氣調(diào)節(jié)系統(tǒng)：1.醫(yī)藥潔凈室空氣凈化處理應根據(jù)空氣潔凈度級別要求合理選用空氣過濾器。2.空氣過濾器的選用和布置方式應符合下列規(guī)定：3.中效空氣過濾器宜集中設(shè)置在凈化空氣處理機組的正壓段。4.高效空氣過濾器宜設(shè)置在浄化空氣調(diào)節(jié)系統(tǒng)的末端。服務于無菌藥品生產(chǎn)的凈化空氣調(diào)節(jié)系統(tǒng)空氣過濾器應設(shè)置在系統(tǒng)的末端。5.在回風和排風系統(tǒng)中,高效空氣過濾器及作為預過濾的中效過濾器應設(shè)置在系統(tǒng)的負壓段。6.空氣過濾器應按小于或等于額定風量選用。7.設(shè)置在同一醫(yī)藥潔凈室內(nèi)的高效過濾器運行時的阻力和效率宜相近。8.高效過濾器的安裝位置與方式應密封、可靠,易于檢漏和更換。純凈水生產(chǎn)潔凈室改造</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/2943590.html</p></div></div></div></div></div><div id="yspr2xj" class="page-right twoColRt"><div id="amjgkwd" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="8873k7n" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強信息推薦自業(yè)物資供應" class="vcenter" 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