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<li><a href="/Products-38204864.html" class="dla">生物實(shí)驗室GMP車(chē)間即用型無(wú)色無(wú)味殺孢子劑</a></li> </ul> </div> </dd> </dl></div> <div id="h5xzb1h" class="MainC fr"> <dl> <dt><span id="9l5r15x" class="STitle fl"><b>技術(shù)文章</b></span><span id="rf5vxrt" class="Position fr">您的位置：<a href="/">網(wǎng)站首頁(yè)</a> ><a href="/article.html">技術(shù)文章</a> >獸藥GMP潔凈室空氣中霉菌超標如何消殺</span></dt> <dd> <div id="9xfnjpj" class="View"> <div id="9px5thh" class="PageView"> <h1 id="inside_rnewtil">獸藥GMP潔凈室空氣中霉菌超標如何消殺</h1> <div id="9xfnntz" class="inside_rnewtime">更新時(shí)間：2023-05-18 點(diǎn)擊次數：537次</div> <div id="xp9ntt5" class="inside_rnewcon"><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">GMP的定義：《藥品生產(chǎn)質(zhì)量管理規范》（Good Manufacturing Practice of Medical Products，GMP）是藥品生產(chǎn)和質(zhì)量管理的基本準則，適用于藥品制劑生產(chǎn)的全過(guò)程和原料藥生產(chǎn)中影響成品質(zhì)量的關(guān)鍵工序。大力推行藥品GMP，是為了最大限度地避免藥品生產(chǎn)過(guò)程中的污染和交叉污染，降低各種差錯的發(fā)生，是提高藥品質(zhì)量的重要措施。</p><p class="ql-align-center" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; text-align: center; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><img src="https://img64.chem17.com/9/20230518/638200034081573080336.png" style="width:800px;"/></p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; text-align: justify; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">在中國，人藥生產(chǎn)和獸藥生產(chǎn)的GMP是不同的，在獸藥GMP廠(chǎng)房?jì)?，在生物制品生產(chǎn)過(guò)程中污染還是時(shí)有發(fā)生的，包括細菌，真菌，支原體污染，獸用生物制品生產(chǎn)過(guò)程中污染的途徑有如下幾個(gè)方面，細胞及種毒，細菌配養、疫苗生產(chǎn)原料及車(chē)間環(huán)境等。</p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; text-align: justify; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">為降低污染和交叉污染的風(fēng)險，廠(chǎng)房、生產(chǎn)設施和設備應當根據所生產(chǎn)獸藥的特性、工藝流程及相應潔凈度級別要求做好合理的消毒殺菌工作。</p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; text-align: justify; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">應當根據獸藥品種、生產(chǎn)操作要求及外部環(huán)境狀況等配置空氣凈化系統，使生產(chǎn)區有效通風(fēng)，并有溫度、濕度控制和空氣凈化過(guò)濾，保證獸藥的生產(chǎn)環(huán)境符合要求。潔凈區與非潔凈區之間、不同級別潔凈區之間的壓差應當不低于10帕斯卡。必要時(shí)，相同潔凈度級別的不同功能區域（操作間）之間也應當保持適當的壓差梯度，并應有指示壓差的裝置和（或）設置監控系統。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">獸藥生產(chǎn)潔凈室（區）分為B級、C級和D級4個(gè)級別。生產(chǎn)不同類(lèi)別獸藥的潔凈室（區）設計應當符合相應的潔凈度要求，包括達到“靜態(tài)"和“動(dòng)態(tài)"的標準。潔凈區的內表面（墻壁、地面、天棚）應當平整光滑、無(wú)裂縫、接口嚴密、無(wú)顆粒物脫落，避免積塵，便于有效清潔，必要時(shí)應當進(jìn)行消毒。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">霉菌，是制藥企業(yè)潔凈區相對來(lái)說(shuō)較難控制的微生物。霉菌的存在勢必會(huì )對產(chǎn)品造成不良的影響，那么本文將會(huì )提供一種新的消毒技術(shù)既可以高效殺滅霉菌抑制其生長(cháng)繁殖又可以輕松通過(guò)驗證，無(wú)毒無(wú)害無(wú)殘留無(wú)腐蝕等優(yōu)點(diǎn)。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">許多制藥企業(yè)依舊在沿用酒精對物體表面進(jìn)行擦拭，酒精對霉菌的抑制效果不是很好。如果采用其它的消毒方法要重新撰寫(xiě)驗證報告，又要考慮殘留和腐蝕性等諸多因素。酒精在標準實(shí)驗室測試可一定程度殺滅霉菌，但現場(chǎng)應用無(wú)法保證濃度，且不能?chē)姙⒌娇諝庵邢?，所以酒精也不能作為控制霉菌的有效方式?/p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">空氣中的霉菌應該怎么處理？</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">空氣樣品中的霉菌回收可能是由于多種原因造成的。表面污染物可能會(huì )傳播到空氣中，因此污染源可能是人員腳部或車(chē)輪帶來(lái)的污染。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">監測設備和擦拭程序不充分，可能是另一個(gè)原因。沒(méi)有HEPA過(guò)濾廢氣的監測設備是污染源。發(fā)生泄漏、HEPA過(guò)濾器損壞后，霉菌在墻壁中生長(cháng)，會(huì )導致空氣中會(huì )回收到霉菌。需要追蹤霉菌直到其來(lái)源，對回收區域進(jìn)行霉菌轉移通路分析，這一點(diǎn)也很重要。通常，死角區域、潔凈室和屏障系統的集成，可能會(huì )使污染物長(cháng)時(shí)間滯留。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">如果在灌裝區域（尤其是RAB中）中發(fā)現了霉菌，則說(shuō)明HEPA之間沒(méi)有擴散膜的區域很難清潔，并且可以容納可能被空氣傳播的污染物。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">最后，根據回收到的霉菌種類(lèi)，尤其是繁殖迅速的半知菌，應考慮非生物因素，例如水分、碳源、礦物油等。由于霉菌的抗性較高，能夠通過(guò)空氣傳播，那選擇的消毒產(chǎn)品必須能夠殺滅霉菌，且能夠用于空氣消毒。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">案例現場(chǎng)狀況：</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">某凈化車(chē)間，總面積約500m2，高度7m，經(jīng)檢測空氣中霉菌超標，需進(jìn)行滅殺工作。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">具體實(shí)施流程：</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">1. 測算空間大?。?00*7=3500m3，需要藥劑量（稀釋后）為：3500*10/1000=35L。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">2. 取3.5L奧克泰士消毒劑，31.5L純凈水，混合稀釋。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">3. 將噴霧設備和藥劑送入車(chē)間，確認車(chē)間無(wú)人后，將藥劑均勻噴灑到空氣中。（時(shí)間段：可選擇上班前60-90分鐘或下班后進(jìn)行）</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">4. 噴霧過(guò)程需關(guān)閉門(mén)窗和通風(fēng)設備，噴霧完畢后封閉60-90分鐘。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">5. 消殺完成。</p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">6. <span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">效果反饋：</span></p><p style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">7. 經(jīng)過(guò)奧克泰士處理后霉菌得到了很好的控制，后期每周進(jìn)行一次消毒工作，車(chē)間的霉菌問(wèn)題得到了解決。</p><p class="ql-align-justify" style="border: 0px; font-size: 16px; margin-top: 0.63em; margin-bottom: 1.8em; padding: 0px; counter-reset: list-1 0 list-2 0 list-3 0 list-4 0 list-5 0 list-6 0 list-7 0 list-8 0 list-9 0; text-align: justify; color: rgb(25, 25, 25); font-family: "PingFang SC", Arial, 微軟雅黑, 宋體, simsun, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="font-weight: 700; border: 0px; margin: 0px; padding: 0px;">針對霉菌，芽孢，支原體、衣原體、噬菌體污染問(wèn)題，基于國內多家客戶(hù)的實(shí)際情況，為實(shí)驗室、科研單位、生產(chǎn)單位、提供精準的支原體、衣原體、噬菌體污染解決方案。</span> 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