新標(biāo)推進(jìn)！無菌車間終端滅菌BFS系通如何更高效，確保無菌？-濟(jì)南辰宇環(huán)?？萍加邢薰?/title> <link href="/skins/518065/Css/Style.css" rel="stylesheet" type="text/css" /> <script type="text/javascript" src="/skins/518065/js/jquery-3.6.0.min.js"></script> <link rel="shortcut icon" href="/skins/518065/favicon.ico"> <script type="application/ld+json"> { "@context": "https://ziyuan.baidu.com/contexts/cambrian.jsonld", "@id": "http:///Article-3988569.html", "title": "新標(biāo)推進(jìn)！無菌車間終端滅菌BFS系通如何更高效，確保無菌？", "pubDate": "2025-04-08T09:02:27", "upDate": "2025-04-16T08:19:50" }</script> <script language="javaScript" src="/js/JSChat.js"></script><script language="javaScript">function ChatBoxClickGXH() { DoChatBoxClickGXH('https://chat.chem17.com',521593) }</script><script>!window.jQuery && document.write('<script src="https://public.mtnets.com/Plugins/jQuery/2.2.4/jquery-2.2.4.min.js">'+'</scr'+'ipt>');</script><script type="text/javascript" src="https://chat.chem17.com/chat/KFCenterBox/518065"></script><script type="text/javascript" src="https://chat.chem17.com/chat/KFLeftBox/518065"></script><script> (function(){ var bp = document.createElement('script'); var curProtocol = window.location.protocol.split(':')[0]; if (curProtocol === 'https') { bp.src = 'https://zz.bdstatic.com/linksubmit/push.js'; } else { bp.src = 'http://push.zhanzhang.baidu.com/push.js'; } var s = document.getElementsByTagName("script")[0]; s.parentNode.insertBefore(bp, s); })(); </script> <meta http-equiv="Cache-Control" content="no-transform" /> <meta http-equiv="Cache-Control" content="no-siteapp" /> <script>var V_PATH="/";window.onerror=function(){ return true; };</script> </head> <body> <h1><a href="http:///">人妻被按摩师玩弄到潮喷,av动图,中文字幕无线精品亚洲乱码一区,久久精品99国产精品</a></h1> <div id="9hl75" class="pl_css_ganrao" style="display: none;"><em id="9hl75"><menuitem id="9hl75"></menuitem></em><progress id="9hl75"></progress><legend id="9hl75"><label id="9hl75"><style id="9hl75"><var id="9hl75"></var></style></label></legend><menuitem id="9hl75"></menuitem><label id="9hl75"></label><i id="9hl75"><track id="9hl75"></track></i><b id="9hl75"><progress id="9hl75"><sup id="9hl75"><strong id="9hl75"></strong></sup></progress></b><pre id="9hl75"><p id="9hl75"><nobr id="9hl75"><font id="9hl75"></font></nobr></p></pre><pre id="9hl75"><label id="9hl75"></label></pre><form id="9hl75"><ins id="9hl75"><pre id="9hl75"><style id="9hl75"></style></pre></ins></form><em id="9hl75"><big id="9hl75"><ol id="9hl75"><pre id="9hl75"></pre></ol></big></em><label id="9hl75"><u id="9hl75"></u></label><track id="9hl75"><em id="9hl75"><big id="9hl75"><dl id="9hl75"></dl></big></em></track><th id="9hl75"><font id="9hl75"></font></th><sub id="9hl75"></sub><form id="9hl75"><legend id="9hl75"></legend></form><listing id="9hl75"><tt id="9hl75"><big id="9hl75"><ol id="9hl75"></ol></big></tt></listing><strong id="9hl75"><ruby id="9hl75"><thead id="9hl75"><thead id="9hl75"></thead></thead></ruby></strong><rp id="9hl75"></rp><u id="9hl75"><mark id="9hl75"></mark></u><dfn id="9hl75"><dfn id="9hl75"></dfn></dfn><listing id="9hl75"><dfn id="9hl75"><big id="9hl75"><span id="9hl75"></span></big></dfn></listing><legend id="9hl75"><dfn id="9hl75"></dfn></legend><rp id="9hl75"></rp><rp id="9hl75"></rp><thead id="9hl75"></thead><label id="9hl75"></label><pre id="9hl75"></pre><pre id="9hl75"></pre><div id="9hl75"></div><dfn id="9hl75"><menuitem id="9hl75"><dl id="9hl75"><pre id="9hl75"></pre></dl></menuitem></dfn><dfn id="9hl75"><dfn id="9hl75"><menuitem id="9hl75"><dl id="9hl75"></dl></menuitem></dfn></dfn><div id="9hl75"><strong id="9hl75"></strong></div><pre id="9hl75"><style id="9hl75"></style></pre><dfn id="9hl75"><menuitem id="9hl75"><dl id="9hl75"><pre id="9hl75"></pre></dl></menuitem></dfn><div id="9hl75"><strong id="9hl75"></strong></div><div id="9hl75"></div><big id="9hl75"></big><sup id="9hl75"><strong id="9hl75"><rp id="9hl75"><thead id="9hl75"></thead></rp></strong></sup><div id="9hl75"></div><progress id="9hl75"></progress><thead id="9hl75"></thead><dl id="9hl75"><pre id="9hl75"><video id="9hl75"><em id="9hl75"></em></video></pre></dl><label id="9hl75"><rp id="9hl75"><thead id="9hl75"><thead id="9hl75"></thead></thead></rp></label><video id="9hl75"><sub id="9hl75"><strike id="9hl75"><var id="9hl75"></var></strike></sub></video><small id="9hl75"></small><style id="9hl75"><th id="9hl75"></th></style><dfn id="9hl75"><menuitem id="9hl75"><dl id="9hl75"><pre id="9hl75"></pre></dl></menuitem></dfn><ol id="9hl75"><optgroup id="9hl75"><output id="9hl75"><address id="9hl75"></address></output></optgroup></ol><mark id="9hl75"><span id="9hl75"></span></mark><optgroup id="9hl75"><ins id="9hl75"></ins></optgroup><strike id="9hl75"></strike><sup id="9hl75"><label id="9hl75"><rp id="9hl75"><thead id="9hl75"></thead></rp></label></sup><ruby id="9hl75"><form id="9hl75"><legend id="9hl75"><dfn id="9hl75"></dfn></legend></form></ruby><dfn id="9hl75"></dfn><small id="9hl75"><output id="9hl75"><acronym id="9hl75"><p id="9hl75"></p></acronym></output></small><track id="9hl75"></track><dl id="9hl75"><i id="9hl75"><track id="9hl75"><em id="9hl75"></em></track></i></dl><progress id="9hl75"><sup id="9hl75"><strong id="9hl75"><ruby id="9hl75"></ruby></strong></sup></progress><pre id="9hl75"></pre><em id="9hl75"><strike id="9hl75"></strike></em><nobr id="9hl75"><font id="9hl75"></font></nobr><label id="9hl75"></label><ins id="9hl75"></ins><dfn id="9hl75"></dfn><video id="9hl75"><sub id="9hl75"><div id="9hl75"><var id="9hl75"></var></div></sub></video><u id="9hl75"><ruby id="9hl75"><span id="9hl75"><legend id="9hl75"></legend></span></ruby></u><progress id="9hl75"><sup id="9hl75"></sup></progress><strong id="9hl75"><rp id="9hl75"><thead id="9hl75"><thead id="9hl75"></thead></thead></rp></strong><font id="9hl75"><legend id="9hl75"></legend></font><nobr id="9hl75"></nobr><nobr id="9hl75"><font id="9hl75"></font></nobr><span id="9hl75"></span><strike id="9hl75"><ol id="9hl75"><optgroup id="9hl75"><output id="9hl75"></output></optgroup></ol></strike><em id="9hl75"></em><em id="9hl75"><div id="9hl75"></div></em><menuitem id="9hl75"><dl id="9hl75"></dl></menuitem><div id="9hl75"><strong id="9hl75"><form id="9hl75"><ins id="9hl75"></ins></form></strong></div><label id="9hl75"><strong id="9hl75"><ruby id="9hl75"><thead id="9hl75"></thead></ruby></strong></label><b id="9hl75"><legend id="9hl75"></legend></b><track id="9hl75"><em id="9hl75"></em></track><small id="9hl75"><meter id="9hl75"></meter></small><var id="9hl75"></var><sup id="9hl75"><strong id="9hl75"><rp id="9hl75"><form id="9hl75"></form></rp></strong></sup><legend id="9hl75"><listing id="9hl75"><tt id="9hl75"><big id="9hl75"></big></tt></listing></legend><th id="9hl75"><b id="9hl75"><progress id="9hl75"><sup id="9hl75"></sup></progress></b></th><ol id="9hl75"><optgroup id="9hl75"></optgroup></ol><th id="9hl75"><font id="9hl75"></font></th><strike id="9hl75"><var id="9hl75"><b id="9hl75"><ins id="9hl75"></ins></b></var></strike><em id="9hl75"><big id="9hl75"><strong id="9hl75"><optgroup id="9hl75"></optgroup></strong></big></em><label id="9hl75"></label><small id="9hl75"><ins id="9hl75"><pre id="9hl75"><p id="9hl75"></p></pre></ins></small><sub id="9hl75"></sub><form id="9hl75"><i id="9hl75"></i></form><pre id="9hl75"></pre><strong id="9hl75"><form id="9hl75"></form></strong><form id="9hl75"></form><address id="9hl75"><p id="9hl75"><var id="9hl75"><b id="9hl75"></b></var></p></address><nobr id="9hl75"><b id="9hl75"></b></nobr><i id="9hl75"></i></div> <div id="rpztrl9" class="headerTop"></div> <div id="vpxztxt" class="header wapper"> <div id="rvbp7tx" class="logo fl"><a href="/"><img src="/skins/518065/Images/logo.png" alt="濟(jì)南辰宇環(huán)保科技有限公司" /></a></div> <div id="h5rzplh" class="headerR fr"> <div id="tnlnhnx" class="headRTop"> <div id="r5jftrr" class="fSearch" style="float:right; margin-right:20px;"> <form id="form1" name="tk" method="post" onsubmit="return checkFrom(this);" action="/products.html"> <input name="keyword" type="text" class="input" value="請輸入您要查詢的產(chǎn)品" onFocus="if (value =='請輸入您要查詢的產(chǎn)品'){value =''}" onBlur="if (value =='')" /> <input type="submit" class="send" value=" " /> <div style=" clear:both;"></div> </form> </div> </div> <div id="n55dftj" class="clear"></div> <div id="hdvhzx7" class="Navgation"> <ul class="nav_list"> <li id="rtjtlbl" class="current"><a href="/">網(wǎng)站首頁</a></li> <li><a href="/products.html" onfocus="this.blur()">產(chǎn)品展示</a></li> <li><a href="/news.html" onfocus="this.blur()">新聞中心</a></li>  <li><a href="/article.html" onfocus="this.blur()" >技術(shù)文章</a></li> <li><a href="/aboutus.html" onfocus="this.blur()" rel="nofollow">關(guān)于我們</a></li> <li><a href="/order.html" onfocus="this.blur()" rel="nofollow">在線留言</a></li> <li><a href="/contact.html" onfocus="this.blur()" rel="nofollow">聯(lián)系我們</a></li> </ul> </div> </div> </div> <script src="http://www.chem17.com/mystat.aspx?u=Oxytech2022"></script>  <div id="75jrxtl" class="clear"></div> <div id="fdvp5lt" class="banner"><img src="/skins/518065/Images/bannerCAbout.jpg"/></div> <div id="t7tx3jj" class="wapper container"> <div id="7rbxv5l" class="Sidebar fl"><dl class="List_pro"> <dt><span id="fdlbxl5" class="Title">產(chǎn)品目錄</span></dt> <dd> <div id="rrfzfff" class="View"> <ul id="pro_nav_lb" class="pro_nav"> <li id="nynavID" class="list_1"> <a href="/ParentList-2372337.html" onmouseover="showsubmenu('殺孢子劑')">殺孢子劑</a> <div class="bp5rznp" id="submenu_殺孢子劑" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2543396.html">外植體消毒</a></li> <li><a href="/SonList-2505577.html">實驗室</a></li> <li><a href="/SonList-2475343.html">醫(yī)療器械，CRO</a></li> <li><a href="/SonList-2407837.html">制藥廠GMP車間消毒劑</a></li> <li><a href="/SonList-2384453.html">食藥企業(yè)</a></li> <li><a href="/SonList-2378978.html">水處理殺菌劑</a></li> <li><a href="/SonList-2378976.html">ro反滲透膜清洗劑</a></li> <li><a href="/SonList-2378961.html">高效滅菌劑</a></li> <li><a href="/SonList-2378549.html">實驗室消毒劑</a></li> <li><a href="/SonList-2378501.html">凈化車間消毒劑</a></li> <li><a href="/SonList-2374603.html">冷霧消毒機(jī)</a></li> <li><a href="/SonList-2373570.html">食品廠消毒</a></li> <li><a href="/SonList-2372338.html">T-010</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2374562.html" onmouseover="showsubmenu('水處理消毒')">水處理消毒</a> <div class="lxn7rnp" id="submenu_水處理消毒" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2428121.html">潤版液殺菌劑</a></li> <li><a href="/SonList-2374565.html">純化水消毒</a></li> <li><a href="/SonList-2374564.html">包裝飲用水消毒</a></li> <li><a href="/SonList-2374563.html">直飲水消毒</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2378042.html" onmouseover="showsubmenu('中藥材黃曲霉毒素降解')">中藥材黃曲霉毒素降解</a> <div class="zh5fznb" id="submenu_中藥材黃曲霉毒素降解" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2378044.html">中藥材黃曲霉毒素</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2378083.html" onmouseover="showsubmenu('農(nóng)業(yè)殺菌劑')">農(nóng)業(yè)殺菌劑</a> <div class="55lr5hv" id="submenu_農(nóng)業(yè)殺菌劑" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2378084.html">果蔬種植</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2383350.html" onmouseover="showsubmenu('食品廠消毒劑')">食品廠消毒劑</a> <div class="h5t35vt" id="submenu_食品廠消毒劑" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2457087.html">保健食品車間消毒液</a></li> <li><a href="/SonList-2450662.html">果蔬保鮮劑</a></li> <li><a href="/SonList-2449479.html">乳制品消毒劑</a></li> <li><a href="/SonList-2383360.html">食品級消毒液</a></li> <li><a href="/SonList-2383351.html">食品廠霉菌消毒劑</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2386768.html" onmouseover="showsubmenu('化妝品消毒劑')">化妝品消毒劑</a> <div class="5tjndnj" id="submenu_化妝品消毒劑" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2498118.html">車間環(huán)境消毒</a></li> <li><a href="/SonList-2448603.html">純水管道消毒劑</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2387070.html" onmouseover="showsubmenu('醫(yī)療器械')">醫(yī)療器械</a> <div class="75zphht" id="submenu_醫(yī)療器械" style=" display:none"> <ul class="pro2_navul"> <li><a href="/SonList-2388943.html">制藥廠消毒劑</a></li> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2403631.html" onmouseover="showsubmenu('表面消毒劑')">表面消毒劑</a> <div class="7xvz5xl" id="submenu_表面消毒劑" style=" display:none"> <ul class="pro2_navul"> </ul> </div> </li> <li id="nynavID" class="list_1"> <a href="/ParentList-2406014.html" onmouseover="showsubmenu('食品管道消毒')">食品管道消毒</a> <div class="phzpdhf" id="submenu_食品管道消毒" style=" display:none"> <ul class="pro2_navul"> </ul> </div> </li> </ul> </div> </dd> </dl> <dl class="ListContact"> <dt><span id="7x5hnzp" class="Title"><a href="/products.html">新品推薦</a></span></dt> <dd class="SCon"> <div id="zd53zn3" class="View"> <ul id="ny_newslb_box" style="margin:5px 10px 10px;"> <li><a href="/Products-38325175.html" class="dla">T-010 1KG實驗室真菌污染消毒劑</a></li> <li><a href="/Products-38315682.html" class="dla">T-010pcr實驗室氣溶膠消毒劑</a></li> <li><a href="/Products-38269906.html" class="dla">T-010食品級消毒劑-實驗室</a></li> <li><a href="/Products-38225874.html" class="dla">D50/500奧克泰士化妝品車間環(huán)境潔凈消毒</a></li> <li><a href="/Products-38204864.html" class="dla">生物實驗室GMP車間即用型無色無味殺孢子劑</a></li> </ul> </div> </dd> </dl></div> <div id="nbdrx5z" class="MainC fr"> <dl> <dt><span id="ptxz5bz" class="STitle fl"><b>技術(shù)文章</b></span><span id="zrxbbfd" class="Position fr">您的位置：<a href="/">網(wǎng)站首頁</a> ><a href="/article.html">技術(shù)文章</a> >新標(biāo)推進(jìn)！無菌車間終端滅菌BFS系通如何更高效，確保無菌？</span></dt> <dd> <div id="tjxdf5f" class="View"> <div id="9x7rxv5" class="PageView"> <h1 id="inside_rnewtil">新標(biāo)推進(jìn)！無菌車間終端滅菌BFS系通如何更高效，確保無菌？</h1> <div id="fzbtxlj" class="inside_rnewtime">更新時間：2025-04-16 點擊次數(shù)：50次</div> <div id="dxbtlvt" class="inside_rnewcon"><h2 style="margin-top:0;margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:黑體;font-size:21px"></span></strong></h2><p style="text-align: center"><br/></p><h2 style="margin-top:0;margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:黑體;font-size:21px">前言</span></strong><strong></strong></h2><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:楷體;font-size:20px"><span style="font-family:楷體">在多數(shù)藥企無菌制劑車間內(nèi)，工藝流程中確保無菌要求、藥品</span><span style="font-family:楷體">API無損是重中之重，生產(chǎn)過程中發(fā)生污染是致命的錯失，其中在粉針、水針?biāo)庮惖犬a(chǎn)品中更為重要，面對國家標(biāo)準(zhǔn)推進(jìn)下，我們?nèi)绾胃玫拇_保工藝流程中無菌環(huán)境的質(zhì)量控制、保護(hù)是我們藥企所面臨的巨大難題。</span></span></p><p style="margin-bottom:31px;text-indent:20px"><span style="font-family: 楷體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:楷體">本文關(guān)鍵詞；</span></span><span style=";font-family:楷體;font-size:20px">BFS系統(tǒng)、微生物、微生物控制、無菌車間、潔凈區(qū)消毒、潔凈區(qū)消毒方式、</span><span style="font-family: 楷體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:楷體">微生物限度、</span></span><span style="font-family: 楷體;font-size: 20px">微生物菌落控制、</span><span style="font-family: 楷體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:楷體">潔凈區(qū)殺孢子劑、潔凈區(qū)、控制區(qū)、潔凈區(qū)消毒滅菌、無菌室、</span></span><span style="font-family: 楷體;font-size: 20px">醫(yī)藥、殺孢子劑、</span><span style="font-family: 楷體;font-size: 20px"><span style="font-family:楷體">工廠潔凈室微生物控制、生物工程</span><span style="font-family:楷體">GMP車間、芽孢、腐蝕性、有效性、空氣物表消毒、一站式消毒滅菌解決方案、技術(shù)咨詢服務(wù)。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family: 宋體;font-size: 20px"><span style="font-family:宋體">面對標(biāo)準(zhǔn)推進(jìn)，許多藥企面對</span><span style="font-family:宋體">BFS系統(tǒng)無法滿足標(biāo)準(zhǔn)無菌，最終滅菌不達(dá)標(biāo)影響藥品質(zhì)量，工藝流程區(qū)段無菌防治不到位等問題，針對以上問題從多維度給出以下解決建議：</span></span></p><h3 style="margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:21px">一．無菌環(huán)境的設(shè)計與建設(shè)</span></strong><strong></strong></h3><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:20px">- 合理規(guī)劃布局</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">：根據(jù)</span><span style="font-family:宋體">BFS系統(tǒng)的工藝流程和操作要求，對無菌車間進(jìn)行合理布局。將人流、物流通道分開，避免交叉污染。設(shè)置不同潔凈級別的區(qū)域，如一般區(qū)、D級控制區(qū)、C級潔凈區(qū)、B級潔凈區(qū)（無菌室人員操作區(qū)）和核心潔凈區(qū)（BFS系統(tǒng)操作區(qū)域），確保從原料進(jìn)入到成品產(chǎn)出的過程中，污染風(fēng)險逐步降低。其中需要注意的是在B級與核心的隔斷窗口鏈接處，我們需要著重管理，</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:20px">- 建筑材料選擇：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">選用符合</span><span style="font-family:宋體">GMP要求的建筑材料，如墻面和天花板采用不產(chǎn)塵、不吸附、易清潔的材料，如彩鋼板；地面采用耐磨、防滑、耐腐蝕的環(huán)氧樹脂自流平地面（拒絕采用白色，防止清潔滅菌過程中，原粉灑落無法目視發(fā)現(xiàn)及清潔）。所有材料應(yīng)能耐受常用消毒劑的侵蝕，且不會釋放有害物質(zhì)影響藥品質(zhì)量。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:20px">- 高效空氣凈化系統(tǒng)：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">安裝先進(jìn)的空氣凈化系統(tǒng)，配備多級空氣過濾器，包括初效、中效和高效過濾器（</span><span style="font-family:宋體">HEPA）。高效過濾器的過濾效率應(yīng)達(dá)到99.99%（對≥0.3μm粒子），確保進(jìn)入無菌車間的空氣達(dá)到規(guī)定的潔凈度要求。合理設(shè)計送風(fēng)口和回風(fēng)口的位置（高度一般為離地15cm厘米為優(yōu)，減少干擾上層操作的空氣流動），形成合理的氣流組織，如單向流或非單向流，以有效排除塵埃粒子和微生物。</span></span></p><h2 style="margin-bottom:31px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:黑體;font-size:21px">二. </span><strong><span style=";font-family:黑體;font-size:21px">無菌環(huán)境的日常質(zhì)量監(jiān)測與維護(hù)</span></strong><strong></strong></h2><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 清潔與消毒：</span></strong><span style="font-family: 宋體;font-size: 20px"><span style="font-family:宋體">在設(shè)備拆卸裝載過程中，會直接觸其內(nèi)部</span><span style="font-family:宋體">環(huán)境，破壞其穩(wěn)定，對于設(shè)備層面我們面對新標(biāo)準(zhǔn)推行，如果設(shè)備無法進(jìn)行更有效的更進(jìn)，那么就需要消毒劑來進(jìn)行輔助修正（工藝流程滿足，內(nèi)部SOP通過），可以采用奧克泰士產(chǎn)品精準(zhǔn)定向處理問題，對于內(nèi)部環(huán)境層面，我們可以使用化學(xué)藥劑進(jìn)行區(qū)域噴灑，利用層流循環(huán)滅菌，從側(cè)面來輔助我們到達(dá)標(biāo)準(zhǔn)。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 塵埃粒子監(jiān)測：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">在無菌車間的不同區(qū)域，尤其是</span><span style="font-family:宋體">BFS系統(tǒng)操作區(qū)域，安裝塵埃粒子計數(shù)器，實時監(jiān)測空氣中的塵埃粒子數(shù)量和粒徑分布。定期進(jìn)行靜態(tài)和動態(tài)監(jiān)測，靜態(tài)監(jiān)測在車間無人且設(shè)備停止運行時進(jìn)行，動態(tài)監(jiān)測則在生產(chǎn)過程中進(jìn)行（動態(tài)時效通常不超過12H生產(chǎn)時間，特殊按照內(nèi)部SOP處理）。根據(jù)監(jiān)測結(jié)果，及時調(diào)整空氣凈化系統(tǒng)的運行參數(shù)或更換過濾器。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 微生物監(jiān)測：</span></strong><span style=";font-family:宋體;font-size:20px">采用多種方法對無菌車間的微生物進(jìn)行監(jiān)測，包括傳統(tǒng)三項：沉降菌測試、浮游菌測試和表面微生物測試。沉降菌測試通過在車間內(nèi)放置瓊脂平板，暴露一定時間后進(jìn)行培養(yǎng)計數(shù)；浮游菌測試使用空氣采樣器收集空氣中的微生物；表面微生物測試則對設(shè)備表面、墻壁、地面等進(jìn)行擦拭采樣。定期進(jìn)行監(jiān)測，并設(shè)定警戒限和行動限，一旦超出范圍，立即采取措施進(jìn)行處理。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 氣流組織控制：</span></strong><span style=";font-family:宋體;font-size:20px">合理設(shè)計潔凈區(qū)內(nèi)的氣流組織形式，如單向流或非單向流。單向流氣流（對于空間操作方式有一定要求，多為從上到下，小幅度緩慢操作）可使空氣以均勻的速度平行流動，將塵埃粒子和微生物迅速帶走，常用于關(guān)鍵操作區(qū)域；非單向流則通過稀釋作用降低空氣中污染物濃度。根據(jù)不同生產(chǎn)環(huán)節(jié)的要求，選擇合適的氣流組織方式，確保無菌環(huán)境。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 溫濕度與壓差控制：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">嚴(yán)格控制無菌車間的溫濕度，溫度一般控制在</span><span style="font-family:宋體">16-22℃，相對濕度控制在45%-65%，以確保藥品質(zhì)量和設(shè)備正常運行。同時，保持不同潔凈級別區(qū)域之間的壓差，一般相鄰區(qū)域壓差應(yīng)不小于10Pa，防止空氣逆流和交叉污染。安裝溫濕度傳感器和壓差表，實時監(jiān)測并記錄數(shù)據(jù)，及時調(diào)整空調(diào)系統(tǒng)的運行參數(shù)。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 操作人員管理：</span></strong><span style=";font-family:宋體;font-size:20px">操作人員是無菌車間微生物污染的重要來源，進(jìn)入車間前，需嚴(yán)格按更衣程序更換無菌工作服、鞋套、帽子、口罩，確保全身包裹嚴(yán)密。操作過程中，盡量減少不必要動作，避免產(chǎn)生過多塵埃和微生物。定期對操作人員進(jìn)行微生物知識培訓(xùn)和健康檢查，防止患病人員進(jìn)入車間。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 工藝用水處理：</span></strong><span style=";font-family:宋體;font-size:20px">BFS 系統(tǒng)使用的工藝用水（如注射用水），要嚴(yán)格控制微生物。采用蒸餾法制備注射用水，并在 80℃以上保溫儲存和循環(huán)輸送，防止微生物滋生。定期對工藝用水進(jìn)行微生物檢測，如每批檢測細(xì)菌內(nèi)毒素，每周檢測微生物限度。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"> </span></p><p style="margin-bottom:21px;margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:21px">三. </span><strong><span style="font-family: 宋體;font-size: 21px">BFS體系總滅菌處理</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:20px">1. </span><strong><span style="font-family: 宋體;font-size: 20px">設(shè)備滅菌</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 濕熱滅菌：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">對于能耐受高溫高濕的設(shè)備部件，如管道、容器等，可采用濕熱滅菌法。常用的設(shè)備是高壓蒸汽滅菌器，通過高溫飽和蒸汽進(jìn)行滅菌。設(shè)定合適的滅菌溫度（多為</span><span style="font-family:宋體">121℃）、壓力和時間（多為15-30分鐘，根據(jù)上一批次藥品品種來規(guī)定調(diào)節(jié)使用，有利于節(jié)能），確保微生物被殺滅。滅菌前需將設(shè)備內(nèi)的空氣排盡，保證蒸汽能夠充分接觸被滅菌物品。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 干熱滅菌</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">：對于一些耐高溫但不宜接觸水分的部件，如玻璃器皿、金屬工具等，采用干熱滅菌法。在干熱滅菌箱中，將物品加熱到較高溫度（如</span><span style="font-family:宋體">160-180℃）并保持一定時間（如2-4小時），以殺滅微生物和破壞熱原。干熱滅菌過程中要注意控制溫度均勻性和通風(fēng)情況。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 化學(xué)滅菌：</span></strong><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">使用化學(xué)消毒劑對設(shè)備表面進(jìn)行擦拭或熏蒸滅菌，如奧克泰士消毒劑等。但需注意化學(xué)消毒劑的殘留問題，使用后要進(jìn)行充分的清洗和通風(fēng)，確保無殘留。對于</span><span style="font-family:宋體">BFS系統(tǒng)的一些關(guān)鍵部位，如灌裝頭，分裝頭（粉針類藥品應(yīng)用），需要進(jìn)行消毒劑噴霧控制</span></span></p><p style="margin-bottom:31px;margin-left:0;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:20px">2. </span><strong><span style="font-family: 宋體;font-size: 20px">生產(chǎn)用具滅菌</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 容器與器具：</span></strong><span style=";font-family:宋體;font-size:20px">直接接觸藥品的容器和器具，如藥瓶、膠塞等，需進(jìn)行嚴(yán)格滅菌。可根據(jù)其材質(zhì)和性質(zhì)選擇合適的滅菌方法，如采取高效的消毒劑奧克泰士等。對于一次性使用的器具，在使用前應(yīng)檢查其包裝的完整性和滅菌標(biāo)識。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 工器具：</span></strong><span style=";font-family:宋體;font-size:20px">生產(chǎn)過程中使用的工器具，如鑷子、剪刀等，應(yīng)在每次使用前后進(jìn)行滅菌處理。可采用濕熱滅菌、干熱滅菌或化學(xué)消毒的方法，確保工器具的無菌狀態(tài)。</span></p><p style="margin-bottom:31px;margin-left:0;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-weight:bold;font-size:20px">3. </span><strong><span style="font-family: 宋體;font-size: 20px">滅菌驗證</span></strong><strong></strong></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 生物指示劑：</span></strong><span style=";font-family:宋體;font-size:20px">在滅菌過程中放置生物指示劑，如嗜熱脂肪芽孢桿菌孢子懸液或菌片等。滅菌后對生物指示劑進(jìn)行培養(yǎng)，觀察是否有微生物生長，以此判斷滅菌效果。生物指示劑的放置位置應(yīng)具有代表性，覆蓋整個滅菌區(qū)域（多為隔斷鏈接處）。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 熱分布測試：</span></strong><span style=";font-family:宋體;font-size:20px">使用溫度傳感器對滅菌設(shè)備內(nèi)的溫度分布進(jìn)行測試，確保滅菌過程中各個部位的溫度均勻性符合要求。通過熱分布測試，可以發(fā)現(xiàn)設(shè)備可能存在的溫度死角，及時調(diào)整滅菌參數(shù)。</span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style="font-family: 宋體;font-size: 20px">- 滅菌效果評估：</span></strong><span style=";font-family:宋體;font-size:20px">定期對滅菌效果進(jìn)行評估，根據(jù)生物指示劑的培養(yǎng)結(jié)果、熱分布測試數(shù)據(jù)以及產(chǎn)品的無菌檢查結(jié)果等，綜合判斷滅菌工藝的有效性。如果發(fā)現(xiàn)滅菌效果不符合要求，應(yīng)及時分析原因并采取糾正措施?？梢圆扇∧M灌裝進(jìn)行實質(zhì)性驗證。</span></p><h5 style="margin-bottom:31px;margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">五. </span><strong><span style=";font-family:宋體;font-size:20px">奧克泰士殺孢子劑優(yōu)勢：</span></strong><strong></strong></h5><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">符合</span><span style="font-family:宋體">2025《中國藥典》規(guī)范，符合新規(guī)理念，對BFS系統(tǒng)設(shè)備友好，不影響設(shè)備精密準(zhǔn)確性。</span></span></p><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">無殘留、無毒衍生物、對人體健康無害，不影響設(shè)備元件、藥品</span><span style="font-family:宋體">API、包材、輔料穩(wěn)定性。</span></span></p><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px">良好的材料兼容性，可以長期規(guī)劃使用。</span></p><p style="margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:Wingdings;font-size:20px">l </span><span style=";font-family:宋體;font-size:20px">滅菌效率無差異，</span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">其主要成分是過氧化氫</span></span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">與銀離子</span></span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">，使用后能夠分解為水和氧氣，</span></span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">不需要后續(xù)沖洗。</span></span></p><p style="margin-bottom:31px;margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family: Wingdings;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)">l </span><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體">滅菌效期長，滿足生產(chǎn)批次生產(chǎn)時間，確保流程正常進(jìn)行，進(jìn)一步保證了生產(chǎn)效率。</span></span></p><p style="margin-bottom:31px;text-indent:20px;text-autospace:ideograph-numeric;line-height:29px"><strong><i><span style="font-family: 宋體;font-size: 20px"><span style="font-family:宋體">針對新規(guī)推進(jìn)，面對</span><span style="font-family:宋體">BFS微生物，終端滅菌問題，建議采用奧克泰士產(chǎn)品！為生產(chǎn)環(huán)境穩(wěn)定、工作效率、微生物控制保駕護(hù)航！我們也將竭誠為您提供專業(yè)技術(shù)服務(wù)：</span></span></i></strong><strong><i></i></strong></p><p style="text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（1）</span><span style=";font-family:宋體;font-size:20px">根據(jù)客戶需求，指導(dǎo)和協(xié)助客戶建立和完善</span><span style=";font-family:宋體;font-size:20px">BFS</span><span style=";font-family:宋體;font-size:20px">系統(tǒng)</span><span style=";font-family:宋體;font-size:20px">殘留溶劑、</span><span style=";font-family:宋體;font-size:20px">微生物</span><span style=";font-family:宋體;font-size:20px">檢驗</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">體系，包括采樣計劃、預(yù)防性消毒程序等工作。</span><span style="font-family:宋體"> </span></span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（2）</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">指導(dǎo)和協(xié)助客戶對實際生產(chǎn)過程中微生物污染進(jìn)行分析查。</span><span style="font-family:宋體"> </span></span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（3）</span><span style=";font-family:宋體;font-size:20px">對各類微生物污染問題提供針對性解決方案，指導(dǎo)和協(xié)助客戶執(zhí)行方案直至解決微生物污染問題，提供閉合鏈條式服務(wù)。</span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（4）</span><span style=";font-family:宋體;font-size:20px">提供后續(xù)管控方案，防范微生物污染的再次發(fā)生。</span></p><p style="margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（5）</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">對客戶現(xiàn)用消毒產(chǎn)品</span><span style="font-family:宋體">/方式的驗證評估提供技術(shù)建議。</span></span></p><p style="margin-bottom:33px;margin-left:0;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:20px">（6）</span><span style=";font-family:宋體;font-size:20px">根據(jù)客戶需求，對客戶員工進(jìn)行微生物學(xué)和消毒學(xué)方面的技術(shù)培訓(xùn)。</span></p><p style="margin-bottom: 31px; text-indent: 20px; line-height: 29px;"><br/></p><p><br/></p><p><br/></p><p><br/></p><p><br/></p></div> <div id="5bt5phf" class="inside_newsthree"> <span><a href="/article.html">返回列表</a><a href="#">返回頂部</a></span> <div class="dzrvl7z" id="clear" ></div> <div> <p>上一篇 : <a href="/Article-3989529.html">《深度揭秘?。?025中國藥典更新，注射劑技術(shù)，要求上新臺階！》</a></p> <p>下一篇 : <a href="/Article-3986313.html">2025《中國藥典》針對包材、輔料上新規(guī)！企業(yè)如何應(yīng)對新規(guī)增訂控制及控制</a></p></div> </div>  </div> </div> </dd> </dl> </div> </div> <div id="5dxdlj5" class="clear"></div> <footer>  <div id="thjdttd" class="foot1"> <div id="fhn5lzz" class="foot1_in clear clearfix"> <ul class="foot_nav"> <li> <div id="xzdj555" class="tlt">關(guān)于我們</div> <a href="/aboutus.html" rel="nofollow">關(guān)于我們</a>  <a href="/order.html" rel="nofollow">在線留言</a> <a href="/contact.html" rel="nofollow">聯(lián)系我們</a> </li> <li id="v5hbpv3" class="cen"> <div id="fpv5hvz" class="tlt">熱銷產(chǎn)品</div> <a href="/Products-37379252.html">D-50/500食品廠車間高效殺滅霉菌芽孢專用消毒劑</a> <a href="/Products-37106142.html">oxytech微米級專業(yè)消毒——Generator冷霧機(jī)</a> <a href="/Products-37105873.html">奧克泰士D50/500礦泉水消毒液解決飲用水銅綠假單胞菌超標(biāo)</a> </li> <li> <div id="vxn5hhh" class="tlt">快速導(dǎo)航</div> <a href="/products.html">產(chǎn)品展示</a> <a href="/news.html">新聞中心</a> <a href="/article.html">技術(shù)文章</a>  </li> </ul> <div id="xlnrfl5" class="ewm"> <p><img src="/skins/518065/images/ewm.jpg" /></p> <p>掃一掃，關(guān)注我們</p> </div> <div id="ddrjdpp" class="lxwm"> <div id="bbdtlxx" class="btn"><a href="/contact.html">聯(lián)系我們</a></div> <p>24小時熱線：</p> <span>0531-66891578</span> </div> </div> </div>  <div id="znpfvth" class="foot2"> <div id="xjbjjvt" class="foot2_in clear clearfix"> <div id="55ntxv5" class="l">Copyright © 2025 濟(jì)南辰宇環(huán)?？萍加邢薰?) 版權(quán)所有</div> <div id="nztnfrb" class="r"><a target="_blank" rel="nofollow">備案號：魯ICP備19006017號-4</a> <a href="/sitemap.xml" target="_blank">sitemap.xml</a> 技術(shù)支持：<a target="_blank" rel="nofollow">化工儀器網(wǎng)</a> <a target="_blank" rel="nofollow">管理登陸</a></div> </div> </div> </footer>   <div class="vhvnrdr" id="gxhxwtmobile" style="display:none;">15665881759</div> <div id="zbd5llz" class="pf_new" style="display:none;"> <div id="5hx5vjz" class="hd"><p>聯(lián)系我們</p><span>contact us</span><em class="close"></em></div> <div id="vnrft5f" class="conn"> <div id="5hl537t" class="lxr"> <a onclick="ChatBoxClickGXH()" href="#" target="_self" class="qq"></a> </div> <div id="frxtvh7" class="tel"><p><img src="/skins/518065/images/pf_icon3.png" />咨詢電話</p><span>15665881759</span></div> <div id="zl5xrrh" class="wx"><p><img src="/skins/518065/images/ewm.jpg" /><i class="iblock"></i></p><span>掃一掃，<em>關(guān)注</em>我們</span></div> </div> <div id="hvjnfp5" class="bd"><a href="javascript:goTop();"><p></p><span>返回頂部</span></a></div> </div> <div id="b5v5zbz" class="pf_new_bx"><p></p><span>聯(lián)<br />系<br />我<br />們</span><em></em></div>  <script type="text/javascript" src="/skins/518065/js/pt_js.js"></script> <script type='text/javascript' src='/js/VideoIfrmeReload.js?v=001'></script> </html> <footer> <div class="friendship-link"> <p>感谢您访问我们的网站，您可能还对以下资源感兴趣：</p> <a href="http:///" title="人妻被按摩师玩弄到潮喷">人妻被按摩师玩弄到潮喷</a> <div class="friend-links"> <html> <head><title>502 Bad Gateway