《中國(guó)藥典》2025更新！我們藥企該如何去更好地防范不可接受微生物？-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://m.szfalin.com/Article-3985400.html", "title": "《中國(guó)藥典》2025更新！我們藥企該如何去更好地防范不可接受微生物？", "pubDate": "2025-04-02T16:33:33", "upDate": "2025-04-03T11:39:42" }</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" 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<dd> <div id="ufmycnec" class="View"> <div id="ufmycnec" class="PageView"> <h1 id="inside_rnewtil">《中國(guó)藥典》2025更新！我們藥企該如何去更好地防范不可接受微生物？</h1> <div id="ufmycnec" class="inside_rnewtime">更新時(shí)間：2025-04-03 點(diǎn)擊次數(shù)：106次</div> <div id="ufmycnec" class="inside_rnewcon"><p style="text-align: center"><img src="https://img46.chem17.com/9/20250403/638792770630668617482.jpg" alt="《中國(guó)藥典》2025更新！我們藥企該如何去更好地防范不可接受微生物？"style="width:800px;"/></p><h3 style="margin-top:0;text-indent:28px;text-autospace:ideograph-numeric;line-height:29px"></h3><p style="text-align: center"><br/></p><h3 style="margin-top:0;text-indent:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:21px">一、</span><strong><span style=";font-family:宋體;font-size:21px">摘要</span></strong><strong></strong></h3><p style="margin-bottom: 33px;line-height: 29px"><span style=";font-family:宋體;font-size:16px"> </span><span style=";font-family:宋體;font-size:20px"> <span style="font-family:宋體">2025《中國(guó)藥典》對(duì)于不可接受微生物做出了更進(jìn)，將洋蔥伯克霍爾德菌（BCC）、嗜熱脂肪芽孢桿菌等納入了</span></span><span style=";font-family:宋體;font-size:20px">藥品生產(chǎn)</span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">的</span><span style="font-family:宋體">“不可接受微生物"范疇，要求相關(guān)企業(yè)建立完善的風(fēng)險(xiǎn)評(píng)估和完整的控制流程，新增指導(dǎo)原則，檢測(cè)方法的變化，對(duì)企業(yè)來(lái)說(shuō)是一個(gè)新的挑戰(zhàn)。 </span></span></p><p style="margin-bottom: 33px;line-height: 29px"><span style=";font-family:楷體;font-size:20px"> <span style="font-family:楷體">本文關(guān)鍵詞：《</span><span style="font-family:楷體">2025中國(guó)藥典》、藥典新規(guī)、不可接受微生物、醫(yī)藥、殺孢子劑、洋蔥伯克霍爾德菌、</span></span><span style=";font-family:楷體;font-size:20px"><span style="font-family:楷體">實(shí)驗(yàn)室消毒、工廠潔凈室微生物控制、生物工程</span><span style="font-family:楷體">GMP車(chē)間微生物、芽孢、BCC、生物膜、微生物限度、腐蝕性、有效性、微生物菌落控制、空氣物表消毒、洋蔥伯克霍爾德菌、一站式解決方案、技術(shù)咨詢服務(wù)、消毒滅菌。</span></span></p><h3 style="margin-top:0"><span style="font-family:宋體;font-size:21px">二. </span><strong><span style=";font-family:宋體;font-size:21px">什么是不可接受微生物</span></strong><strong></strong></h3><h4><strong><span style=";font-family:黑體;font-size:19px">（一）定義</span></strong><strong></strong></h4><p style="margin-left: 20px;line-height: 29px"><span style=";font-family:宋體;font-size:20px"> <span style="font-family:宋體">指在特定的條件、環(huán)境或產(chǎn)品中，其存在、數(shù)量、活性、或種類(lèi)</span></span></p><p style="margin-bottom: 33px;line-height: 29px"><span style=";font-family:宋體;font-size:20px">等方面不符合既定標(biāo)準(zhǔn)、規(guī)范、法規(guī)要求或預(yù)期用途，并可能來(lái)帶不良影響的污染物。</span></p><h4 style="margin-left:20px;text-indent:0"><span style="font-family:黑體;font-size:19px">（二）</span><strong><span style=";font-family:黑體;font-size:19px">不同區(qū)域常見(jiàn)的不可接受微生物</span></strong><strong></strong></h4><p style="margin-bottom: 11px;text-indent: 40px;line-height: 29px"><strong><span style=";font-family:宋體;font-size:19px">高級(jí)潔凈區(qū)：</span></strong><span style=";font-family:宋體;font-size:20px">理論上要求絕對(duì)無(wú)菌，任何微生物都不允許都屬于不可接受微生物。</span></p><p style="margin-bottom: 11px;text-indent: 40px;line-height: 29px"><strong><span style=";font-family:宋體;font-size:19px">B級(jí)潔凈區(qū)</span></strong><strong><span style=";font-family:宋體;font-size:19px">：</span></strong><span style=";font-family:宋體;font-size:20px">對(duì)洋蔥伯克霍爾德菌、金黃色葡萄球菌、銅綠假單細(xì)胞菌、枯草芽孢桿菌等不可接受，對(duì)非致病菌也有極低的限制要求，少量的普通細(xì)菌，霉菌和酵母菌超出一定的限度也屬于不可接受微生物。</span></p><p style="margin-bottom: 11px;text-indent: 40px;line-height: 29px"><strong><span style=";font-family:宋體;font-size:19px">C級(jí)潔凈區(qū)：</span></strong><span style=";font-family:宋體;font-size:20px">致病菌如大腸桿菌、沙門(mén)氏菌，銅綠假單胞菌等都屬于不可接受微生物，特定非致病菌如枯草芽孢桿菌，白色念珠菌等也都屬于不可接受微生物，影響藥品穩(wěn)定性的細(xì)菌超出一定限度通為不可接受微生物。</span></p><p style="margin-bottom: 33px;text-indent: 40px;line-height: 29px"><strong><span style=";font-family:宋體;font-size:19px">D級(jí)控制區(qū)</span></strong><strong><span style=";font-family:宋體;font-size:19px">：</span></strong><span style=";font-family:宋體;font-size:20px">對(duì)以上所述細(xì)菌真菌都有一定的限度，但超出限度劃分為不可接受微生物。</span></p><h3><strong><span style=";font-family:宋體;font-size:21px"><span style="font-family:宋體">三</span><span style="font-family:Calibri">.</span><span style="font-family:宋體">藥廠產(chǎn)品生產(chǎn)環(huán)境要求</span></span></strong><strong></strong></h3><h3 style="text-indent:43px"><strong><span style=";font-family:宋體;font-size:21px">廠房設(shè)施</span></strong><strong></strong></h3><h5 style="text-indent:37px"><strong><span style=";font-family:宋體;font-size:19px"><span style="font-family:Calibri">1.</span><span style="font-family:宋體">外部布局（選址）：</span></span></strong><strong></strong></h5><p style="margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"> <span style="font-family:宋體">遠(yuǎn)離重化工企業(yè)，垃圾處理場(chǎng)等，具有空氣污染污染源的場(chǎng)地，目的是減少外界污染物對(duì)于非無(wú)菌固體藥品生產(chǎn)的影響。</span></span></p><h5 style="text-indent:37px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px"><span style="font-family:Calibri">2.</span><span style="font-family:宋體">內(nèi)部布局：</span></span></strong><strong></strong></h5><p style="margin-bottom:33px;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">應(yīng)遵循工藝流程來(lái)劃分區(qū)域，如原料儲(chǔ)存區(qū)，生產(chǎn)操作區(qū)，中成品暫放區(qū)，成品包裝存放區(qū)，包材存放區(qū)，各區(qū)域之間需有有效隔離，避免環(huán)境交叉感染造成污染不可追尋，此外須有人員以及包裝物流單獨(dú)通道，防止污染侵入，在潔凈區(qū)必須設(shè)置緩沖房間，進(jìn)行人員更衣緩沖以及</span><span style="font-family:Calibri">VHP</span><span style="font-family:宋體">熏蒸緩沖，保護(hù)不同等級(jí)鏈接環(huán)境，</span></span></p><h3><strong><span style=";font-family:宋體;font-size:21px"><span style="font-family:宋體">四</span><span style="font-family:Calibri">.</span><span style="font-family:宋體">潔凈區(qū)域條件及其防范</span></span></strong><strong></strong></h3><h5 style="margin-bottom:33px;text-indent:37px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px">1.潔凈級(jí)別：</span></strong><strong></strong></h5><p style="text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">無(wú)菌藥品主生產(chǎn)在</span><span style="font-family:Calibri">A</span><span style="font-family:宋體">、</span><span style="font-family:Calibri">B</span><span style="font-family:宋體">級(jí)，要求十分嚴(yán)格，</span><span style="font-family:Calibri">B</span><span style="font-family:宋體">級(jí)作為人員操作區(qū)域空氣潔凈度需要達(dá)到</span><span style="font-family:Calibri">ISO7</span><span style="font-family:宋體">級(jí)標(biāo)準(zhǔn)，即空氣懸浮粒子數(shù)</span><span style="font-family:Calibri">352000</span><span style="font-family:宋體">單位≥</span><span style="font-family:Calibri">0.5</span><span style="font-family:宋體">μ</span><span style="font-family:Calibri">m/m</span><span style="font-family:宋體">3，</span><span style="font-family:Calibri">2900</span><span style="font-family:宋體">單位≥</span><span style="font-family:Calibri">5</span><span style="font-family:宋體">μ</span><span style="font-family:Calibri">m/m</span><span style="font-family:宋體">3（不同公司內(nèi)部</span><span style="font-family:Calibri">sop</span><span style="font-family:宋體">標(biāo)準(zhǔn)不同），浮游菌最大允許數(shù)</span><span style="font-family:Calibri">70CFU</span><span style="font-family:宋體">≥</span><span style="font-family:Calibri">m</span><span style="font-family:宋體">3，沉降菌最大允許數(shù)</span><span style="font-family:Calibri">5CFU/90mm</span><span style="font-family:宋體">培養(yǎng)皿。</span></span></p><p style="margin-bottom:33px;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">目前非無(wú)菌固體產(chǎn)品面對(duì)</span><span style="font-family:Calibri">2025</span><span style="font-family:宋體">《中國(guó)藥典》不可接受微生物的更新，成為重點(diǎn)管控對(duì)象，多數(shù)非無(wú)菌固體產(chǎn)品的主生產(chǎn)在</span><span style="font-family:Calibri">C</span><span style="font-family:宋體">、</span><span style="font-family:Calibri">D</span><span style="font-family:宋體">級(jí)協(xié)作生產(chǎn)，人員操作區(qū)域在</span><span style="font-family:Calibri">D</span><span style="font-family:宋體">級(jí)，該區(qū)域空氣懸浮粒子（塵埃粒子）標(biāo)準(zhǔn)為≥</span><span style="font-family:Calibri">0.5</span><span style="font-family:宋體">μ</span><span style="font-family:Calibri">m/m</span><span style="font-family:宋體">3的粒子不超</span><span style="font-family:Calibri">3520000</span><span style="font-family:宋體">單位（不同公司內(nèi)部</span><span style="font-family:Calibri">SOP</span><span style="font-family:宋體">標(biāo)準(zhǔn)不同）：≥</span><span style="font-family:Calibri">5</span><span style="font-family:宋體">μ</span><span style="font-family:Calibri">m/m</span><span style="font-family:宋體">3的粒子數(shù)不超過(guò)</span><span style="font-family:Calibri">29000</span><span style="font-family:宋體">單位：微生物最大允許數(shù)浮游菌≤</span><span style="font-family:Calibri">10CFU</span><span style="font-family:宋體">，沉降菌≤</span><span style="font-family:Calibri">5CFU</span><span style="font-family:宋體">。</span></span></p><h5 style="text-indent:37px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px"><span style="font-family:Calibri">2.</span><span style="font-family:宋體">空氣系統(tǒng)：</span></span></strong><strong></strong></h5><p style="margin-bottom:33px;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">采取上傳下送的空氣流動(dòng)組織方式，在潔凈區(qū)域形成單向流動(dòng)，使得微生物停留在設(shè)備表面的時(shí)間減少，高效過(guò)濾器需要每周檢查一次，月更（視情況而定），季更（對(duì)于高要求強(qiáng)制），年更檢驗(yàn)（強(qiáng)制）高效過(guò)濾器需要過(guò)濾進(jìn)入的空氣，確保進(jìn)入的空氣進(jìn)行高效的過(guò)濾，形成良性循環(huán)。在潔凈區(qū)域，為避免懸浮粒子超標(biāo)、人員污染與影響生產(chǎn)，人員走動(dòng)速度設(shè)定為</span><span style="font-family:Calibri">0.49M/S</span><span style="font-family:宋體">，且人員切勿在回風(fēng)口處長(zhǎng)期停留，防止細(xì)菌攜帶造成大范圍的無(wú)追蹤污染，對(duì)于后續(xù)的處理有很大的難度。</span></span></p><h5 style="text-indent:37px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px"><span style="font-family:Calibri">3.</span><span style="font-family:宋體">壓差控制</span><span style="font-family:Calibri">:</span></span></strong><strong></strong></h5><p style="margin-bottom:33px;text-indent:40px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">潔凈區(qū)與控制區(qū)之間、不同潔凈區(qū)等級(jí)之間存在一定的壓強(qiáng)差，通常不會(huì)超過(guò)</span><span style="font-family:Calibri">10Pa</span><span style="font-family:宋體">，壓差會(huì)保持相對(duì)穩(wěn)定，壓差控制使高等級(jí)區(qū)域向低等級(jí)區(qū)域形成單向氣體流動(dòng)，是為了防止外界的可能污染物進(jìn)入潔凈區(qū)，保護(hù)了潔凈區(qū)的環(huán)境穩(wěn)定，倘若破壞了區(qū)域間的壓強(qiáng)差，需要及時(shí)關(guān)閉通口，進(jìn)行壓強(qiáng)復(fù)壓并且深度清潔滅菌區(qū)域鏈接以及緩沖間，運(yùn)用殺孢子劑進(jìn)行區(qū)域滅菌。</span></span></p><h5 style="text-indent:37px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px">4.輔助措施</span></strong><strong><span style=";font-family:宋體;font-size:19px">：</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">高效過(guò)濾器的運(yùn)用，控制最大通過(guò)風(fēng)速為</span><span style="font-family:宋體">0.27M/S，進(jìn)行有效的空氣過(guò)濾，滿足ISO7級(jí)標(biāo)準(zhǔn)</span></span><span style=";font-family:宋體;font-size:20px">，從空氣入手保護(hù)生產(chǎn)環(huán)境穩(wěn)定。</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">在關(guān)鍵區(qū)域持續(xù)打開(kāi)區(qū)域?qū)恿?/span><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">，風(fēng)速為</span><span style="font-family:宋體">0.36--0.54M/S（指導(dǎo)值）</span></span><span style=";font-family:宋體;font-size:20px">，防止微生物長(zhǎng)時(shí)間聚集，減少污染爆發(fā)的可能，從防范上著手治理。</span></p><p style="margin-bottom:33px;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">利用專(zhuān)業(yè)的消毒滅菌產(chǎn)品如奧克泰士等，能夠有效的控制生產(chǎn)高標(biāo)準(zhǔn)環(huán)境，是潔凈區(qū)的理想選擇，適合長(zhǎng)期規(guī)劃使用。</span></p><h3 style="margin-top:0;margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:21px"><span style="font-family:宋體">四</span><span style="font-family:宋體">.清潔滅菌防范不可接受微生物</span></span></strong><strong></strong></h3><h4 style="margin-top:0;margin-bottom:0;text-indent:19px;text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px">（一）日常清潔滅菌</span></strong><strong></strong></h4><p style="text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:16px"> </span></p><p style="text-indent:40px;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"><span style="font-family:宋體">制定嚴(yán)格的日常清潔滅菌制度，在每批次</span><span style="font-family:宋體">/班生產(chǎn)結(jié)束后對(duì)生產(chǎn)設(shè)備、地面、墻面、工作臺(tái)、輔助房間，生產(chǎn)干預(yù)工具進(jìn)行清潔滅菌。其中復(fù)次滅菌需要用到高效的殺孢子劑，傳統(tǒng)的消毒劑與殺孢子劑局限性太強(qiáng)且滅菌效果不理想、有殘留、腐蝕性、安全性、刺鼻氣味，推薦使用奧克泰士即用型殺孢子劑進(jìn)行高效的滅菌，保護(hù)生產(chǎn)環(huán)境的穩(wěn)定，</span></span><span style=";font-family:宋體;font-size:20px">滅菌效果更優(yōu)，對(duì)滅菌保護(hù)工藝設(shè)備層面有著很大的幫助，最終產(chǎn)物為水和氧氣，對(duì)人員安全有保障，其作用時(shí)間快，不影響區(qū)間操作。</span></p><p style="margin-bottom:33px;text-indent:40px;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">進(jìn)行定期消毒滅菌，每周對(duì)生產(chǎn)區(qū)進(jìn)行全面的清潔滅菌，傳統(tǒng)滅菌往往使用</span><span style="font-family:宋體">75%乙醇，季銨鹽類(lèi)消毒劑等，每周進(jìn)行交替消毒滅菌，但傳統(tǒng)的消毒劑滅菌效果欠佳且局限性大，容易導(dǎo)致高抗性的細(xì)菌出現(xiàn)，奧克泰士殺孢子劑解決了傳統(tǒng)方式可能帶來(lái)的問(wèn)題，由于其高質(zhì)量的成分：過(guò)氧化氫＋活性銀離子，極大程度的避免了高抗性微生物的產(chǎn)生，對(duì)生產(chǎn)環(huán)境有著高效的保障。</span></span></p><p style="margin-left:19px;text-indent:0;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:19px">(二) </span><strong><span style=";font-family:宋體;font-size:19px">緊急處理滅菌</span></strong><strong></strong></p><p style="text-autospace:ideograph-numeric;line-height:29px"><strong><span style=";font-family:宋體;font-size:19px"> </span></strong></p><p style="margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"> <span style="font-family:宋體">在藥品生產(chǎn)過(guò)程中，如果發(fā)生緊急污染，應(yīng)當(dāng)停機(jī)進(jìn)行緊急處理，在面對(duì)這樣的情況時(shí)，傳統(tǒng)的試劑對(duì)于藥品的影響是不容忽視的，在穩(wěn)定環(huán)境的同時(shí)會(huì)對(duì)該批次藥品做成一定不可逆的影響，其穩(wěn)定環(huán)境效果、時(shí)效、所需時(shí)間都嚴(yán)重影響到生產(chǎn)的進(jìn)行，生產(chǎn)時(shí)間延長(zhǎng)，效率下降，帶來(lái)后續(xù)生產(chǎn)污染處理的影響難以彌補(bǔ)，所以我推薦使用奧克泰士殺孢子劑，在同樣的環(huán)境下，奧克泰士憑借自己高效、無(wú)害、無(wú)腐蝕，安全性高的特點(diǎn)，在保障人員健康安全的同時(shí)，快速地穩(wěn)定了生產(chǎn)環(huán)境，減免了后續(xù)一系列的層進(jìn)影響，作為緊急處理滅菌的用品十分可靠。</span></span></p><h3 style="margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family:宋體;font-size:21px">五. </span><strong><span style=";font-family:宋體;font-size:21px">奧克泰士殺孢子劑的優(yōu)勢(shì)</span></strong><strong></strong></h3><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">高效廣譜殺菌，對(duì)芽孢、霉菌</span><span style="font-family:宋體">(孢子)等高抗性微生物殺菌率菌大于5個(gè)對(duì)數(shù)值(>99.999%)</span></span><span style=";font-family:宋體;font-size:20px">。</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">無(wú)殘留、無(wú)毒衍生物、對(duì)人體健康無(wú)害，不影響藥品的質(zhì)量。</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">操作簡(jiǎn)單便捷，作用迅速，短時(shí)間內(nèi)可以獲得高效的滅菌效果。</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，對(duì)工藝設(shè)備友好基本無(wú)腐蝕，大大延長(zhǎng)了設(shè)備的使用壽命，可以長(zhǎng)期規(guī)劃使用。</span></p><p style="margin-bottom:33px;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">其主要成分是過(guò)氧化氫，使用后能夠分解為水和氧氣，因此它是一種對(duì)環(huán)境友好的生態(tài)殺孢子劑，非常適合長(zhǎng)期使用。</span></span></p><p style="margin-bottom:33px;margin-left:28px;text-autospace:ideograph-numeric;line-height:29px"><span style="font-family: 宋體;letter-spacing: 0;font-size: 20px;background: rgb(255, 255, 255)"><span style="font-family:宋體"></span></span></p><p style="text-align: center"><br/></p><p style="margin-bottom:33px;text-indent:43px;text-autospace:ideograph-numeric"><span style="font-family: 楷體;font-size: 21px">奧克泰士為確保企業(yè)能夠充分利用奧克泰士產(chǎn)品的優(yōu)勢(shì)，我們提供的豐富有效專(zhuān)業(yè)技術(shù)指導(dǎo)！</span></p><p style="margin-bottom:33px;text-autospace:ideograph-numeric"><span style="font-family: 楷體;font-size: 21px">我們將提供以下針對(duì)性服務(wù)：</span></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"><span style="font-family:宋體">根據(jù)客戶需求，指導(dǎo)和協(xié)助客戶建立和完善生產(chǎn)系統(tǒng)微生物風(fēng)險(xiǎn)的防范體系，包括采樣計(jì)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(duì)實(shí)際生產(chǎn)過(guò)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(duì)各類(lèi)微生物污染問(wèn)題提供針對(duì)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(wèn)題，提供閉合鏈條式服務(wù)。</span></p><p style="margin-left: 0px; line-height: 29px; text-indent: 0em;"><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: 0px; text-indent: 0px; margin-bottom: 5px; line-height: 1.75em;"><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(duì)客戶現(xiàn)用消毒產(chǎn)品</span><span style="font-family:宋體">/方式的驗(yàn)證評(píng)估提供技術(shù)建議。</span></span></p><p style="margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體">（</span><span style="font-family:宋體">6）根據(jù)客戶需求，對(duì)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></span></p><p style="margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><span style=";font-family:宋體;font-size:20px"><span style="font-family:宋體"></span></span></p><p style="text-align: center"><img src="https://img49.chem17.com/9/20250403/638792771635256534771.jpg" alt="《中國(guó)藥典》2025更新！我們藥企該如何去更好地防范不可接受微生物？"style="width:800px;"/></p><p style="margin-bottom:33px;text-autospace:ideograph-numeric;line-height:29px"><br/></p><p style="text-align: center"><img src="https://img49.chem17.com/9/20250402/638792060027064297830.jpg" style="max-width:800px;max-height:300%;" title="德國(guó)與歐盟認(rèn)證.jpg"/></p><p style="text-align: center"><br/></p><p style="text-align: center"><br/></p><p><span 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