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#f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>浙江恒溫潔凈室設(shè)計(jì),潔凈室</p><p><span>***更新：</span>2020-12-29 03:17:26</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="ktoehxs" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">上海譽(yù)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(jī): </span>021-00000000</p><p><span>地址: </span>長(zhǎng)壽路868號(hào)中港匯大廈</p><p>[當(dāng)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="l2ojua8" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="illb8yj" class="box"><p><p style="text-indent:25px">潔凈注射用水的制備、儲(chǔ)存和使用應(yīng)符合下列規(guī)定:1.注射用水的制備方式應(yīng)保證其水質(zhì)符合現(xiàn)行《中華人民共和國(guó)藥典》的注射用水標(biāo)準(zhǔn)的規(guī)定。2.用于注射用水儲(chǔ)罐和輸送管道、管件等的材料應(yīng)無(wú)毒、耐腐蝕、耐高溫滅菌,并應(yīng)釆用內(nèi)壁拋光的較好不銹鋼管或其他不污染注射用水的材料。儲(chǔ)罐的通氣口應(yīng)安裝不脫落纖維的疏水性除菌過(guò)濾器。3，浙江恒溫潔凈室設(shè)計(jì).注射用水輸送管道系統(tǒng)應(yīng)采取循環(huán)方式，浙江恒溫潔凈室設(shè)計(jì)，浙江恒溫潔凈室設(shè)計(jì)。設(shè)計(jì)和安裝時(shí)不應(yīng)岀現(xiàn)使水滯留和不易清潔的死角。循環(huán)干管的回水流速不應(yīng)小于1m/s,循環(huán)溫度可保持在70℃以上,不循環(huán)支管長(zhǎng)度不宜大于支管管徑的3倍。注射用水終端凈化裝置的設(shè)置應(yīng)靠近使用點(diǎn)。4.注射用水儲(chǔ)存和輸送系統(tǒng)應(yīng)設(shè)置在線清洗、在線消毒設(shè)施。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。浙江恒溫潔凈室設(shè)計(jì)</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江恒溫潔凈室設(shè)計(jì),潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265316434128/1960022.png"></div><p style="text-indent:25px">潔凈廠址選擇和總平面布置：1.廠址選擇2.Ⅰ廠區(qū)位置的選擇應(yīng)經(jīng)技術(shù)經(jīng)濟(jì)方案比較后確定,并應(yīng)符合下列規(guī)定:3.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。4.應(yīng)遠(yuǎn)離鐵路、碼頭、機(jī)場(chǎng)、交通要道,以及散發(fā)大量粉塵和有害氣體的工廠、倉(cāng)儲(chǔ)、堆場(chǎng),遠(yuǎn)離嚴(yán)重空氣污染、水質(zhì)污染、振動(dòng)或噪聲干擾的區(qū)域;不能遠(yuǎn)離以上區(qū)域時(shí),應(yīng)位于其全年zui 小頻率風(fēng)向的下風(fēng)側(cè)。5.醫(yī)藥工業(yè)潔凈廠房?jī)艋諝庹{(diào)節(jié)系統(tǒng)的新風(fēng)口與交通主干道近基地側(cè)道路紅線之間的距離宜大于50m。浙江恒溫潔凈室設(shè)計(jì)潔凈室無(wú)菌生產(chǎn)潔凈室應(yīng)**于采用無(wú)菌生產(chǎn)工藝的藥品的生產(chǎn),不應(yīng)用于其他藥品的生產(chǎn)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江恒溫潔凈室設(shè)計(jì),潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265454890927/4884884.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)。</p><p style="text-indent:25px">潔凈無(wú)菌生產(chǎn)潔凈室內(nèi)不應(yīng)設(shè)置地漏和水斗。無(wú)菌生產(chǎn)潔凈室所用的水應(yīng)經(jīng)過(guò)滅菌處理。無(wú)菌生產(chǎn)潔凈室內(nèi)的設(shè)備/器具使用完畢后應(yīng)移出本區(qū)域清洗,并經(jīng)過(guò)滅菌后進(jìn)入。采用在線清洗在線消毒的生產(chǎn)設(shè)備,其下水/凝水應(yīng)直接排出無(wú)菌生產(chǎn)潔凈室外。1.無(wú)菌生產(chǎn)潔凈室內(nèi)設(shè)備通氣口應(yīng)設(shè)置除菌過(guò)濾器。滅菌產(chǎn)生的水蒸氣應(yīng)排出無(wú)菌生產(chǎn)潔凈室。2.無(wú)菌生產(chǎn)潔凈室應(yīng)設(shè)置環(huán)境消毒/滅菌設(shè)施.以降低環(huán)境的微生物負(fù)荷。無(wú)菌生產(chǎn)潔凈室內(nèi)使用的清洗劑/消毒劑應(yīng)經(jīng)過(guò)滅菌/除菌處理。3.無(wú)菌生產(chǎn)潔凈室的凈化更衣設(shè)施應(yīng)滿足本標(biāo)準(zhǔn)第5.2.2條、第5.2.4條的要求。潔凈室醫(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。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="浙江恒溫潔凈室設(shè)計(jì),潔凈室" src="https://tyunfile.71360.com/UploadFile/shyumao/637387265560613581/2907407.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(yīng)設(shè)置物料凈化用室和設(shè)施。2.進(jìn)入無(wú)菌生產(chǎn)潔浄室的原輔料、包裝材料和其他物品,除應(yīng)符合本標(biāo)準(zhǔn)第5.3.1條的規(guī)定外,尚應(yīng)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(yīng)設(shè)置氣鎖或傳遞柜。氣鎖的靜態(tài)凈化級(jí)別應(yīng)與其相鄰高級(jí)別醫(yī)藥潔凈室一致。4.傳遞柜應(yīng)密閉良好,并應(yīng)易于清潔。兩邊的傳遞門(mén)應(yīng)有防止同時(shí)被開(kāi)啟的措施。傳遞柜的尺寸和結(jié)構(gòu)應(yīng)滿足傳遞物品的要求。傳送至無(wú)菌生產(chǎn)潔凈室的傳遞柜應(yīng)有相應(yīng)的凈化設(shè)施。5.醫(yī)藥潔凈室產(chǎn)生的廢棄物應(yīng)有傳出通道。易產(chǎn)生污染的廢棄物應(yīng)設(shè)置單獨(dú)的出口。具有活性或毒性的生物廢棄物應(yīng)滅活后傳出。潔凈室醫(yī)藥工藝用水醫(yī)藥生產(chǎn)工藝過(guò)程中使用的水,包括生活飲用水、純化水、注射用水。浙江恒溫潔凈室設(shè)計(jì)</p><p style="text-indent:25px">潔凈室在線滅菌設(shè)施的下水及蒸汽凝水必須排出本區(qū)域外。浙江恒溫潔凈室設(shè)計(jì)</p><p style="text-indent:25px">潔凈人員凈化用室和生活用室的設(shè)計(jì)應(yīng)符合下列規(guī)定:1.人員凈化用室入口處應(yīng)設(shè)置凈鞋設(shè)施。2.存外衣區(qū)域應(yīng)單獨(dú)設(shè)置,存衣柜應(yīng)根據(jù)設(shè)計(jì)人數(shù)每人一柜。3.人員凈化用室應(yīng)按氣鎖設(shè)計(jì),脫外衣和穿潔凈衣的區(qū)域應(yīng)分開(kāi)。必要時(shí),可將進(jìn)入和離開(kāi)醫(yī)藥潔凈室的更衣間分開(kāi)設(shè)置。4.人員凈化用室的空氣凈化要求應(yīng)符合本標(biāo)準(zhǔn)第9.2.13條的規(guī)定。5.廁所和浴室不得設(shè)置在醫(yī)藥潔凈室內(nèi),且不得與生產(chǎn)區(qū)和倉(cāng)儲(chǔ)區(qū)直接相通。6.青霉素等高致敏***品、某些甾體藥品、高活***品及其他有毒有害藥品的人員凈化用室,應(yīng)采取防止有毒有害物質(zhì)被人體帶出人員凈化用室的措施。7.醫(yī)藥工業(yè)潔凈廠房?jī)?nèi)人員凈化用室和生活用室的面積,應(yīng)根據(jù)不同生產(chǎn)工藝要求和工作人員數(shù)量確定。浙江恒溫潔凈室設(shè)計(jì)</p><p style="text-indent:25px">上海譽(yù)茂凈化科技有限公司致力于建筑、建材，是一家服務(wù)型公司。公司業(yè)務(wù)涵蓋潔凈工程，潔凈工廠，潔凈車(chē)間，潔凈實(shí)驗(yàn)室等，價(jià)格合理，品質(zhì)有保證。公司注重以質(zhì)量為中心，以服務(wù)為理念，秉持誠(chéng)信為本的理念，打造建筑、建材良好品牌。在社會(huì)各界的鼎力支持下，持續(xù)創(chuàng)新，不斷鑄造***服務(wù)體驗(yàn)，為客戶成功提供堅(jiān)實(shí)有力的支持。</p></p><br /><p>文章來(lái)源地址: http://www.cdcfah.com/cp/2607884.html</p></div></div></div></div></div><div id="3uzfoz8" 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